Document text
Page 1 of 197
***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: 11471007 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 version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
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(b) (4)
FDA-CBER-2021-5683-0810830
Page 2 of 197
***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: 11471007 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
Aug/3/2020
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810831
Page 3 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11471007]
2.Birth Date: /1984
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:
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810832
Page 4 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/3/2020
2.Erroneous Visit
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810833
Page 5 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
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Page 6 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in
the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810835
Page 7 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810836
Page 8 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810837
Page 9 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810838
Page 10 of 197
***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: 11471007 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:[intermittent lumbosacral disc herniation]
Start Date: UNK/UNK/2006
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[menarche female]
Start Date: UNK/UNK/1996
Ongoing: YES
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810839
Page 11 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Aug/3/2020
2.Weight: [104.3]
3.Unit: kg
4.Height: [172.7]
5.Unit: cm
6.Body Mass Index: [35.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810840
Page 12 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/3/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810841
Page 13 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/3/2020
2.Randomization Number: [40580]
3.Randomization Group: [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810842
Page 14 of 197
***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: 11471007 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:
Aug/3/2020
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 [BPL417]
5.bSample ID [BPL418]
5.cSample ID [BM7Y2F]
5.dSample ID [BM7Y2G]
5.eSample ID [BM7Y2H]
5.fSample ID [BM7Y2J]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810843
Page 15 of 197
***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: 11471007 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:
Aug/3/2020
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 [BM7Y1G]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810844
Page 16 of 197
***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: 11471007 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: Aug/3/2020 15:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810845
Page 17 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810846
Page 18 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810847
Page 19 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/10/2020
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810848
Page 20 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810849
Page 21 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810850
Page 22 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/24/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810851
Page 23 of 197
***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: 11471007 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:
Aug/24/2020
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 [BPY322]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810852
Page 24 of 197
***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: 11471007 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: Aug/24/2020 10:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810853
Page 25 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810854
Page 26 of 197
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810855
Page 27 of 197
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810856
Page 28 of 197
***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: 11471007 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/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY3K2]
5.bSample ID [BPY3K3]
5.cSample ID [BPLF6L]
5.dSample ID [BPLF66]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810857
Page 29 of 197
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810858
Page 30 of 197
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810859
Page 31 of 197
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810860
Page 32 of 197
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 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 [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810861
Page 33 of 197
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810862
Page 34 of 197
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 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 [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810863
Page 35 of 197
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810864
Page 36 of 197
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810865
Page 37 of 197
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 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 [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810866
Page 38 of 197
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 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 [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810867
Page 39 of 197
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810868
Page 40 of 197
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810869
Page 41 of 197
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810870
Page 42 of 197
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 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 [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810871
Page 43 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810872
Page 44 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810873
Page 45 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810874
Page 46 of 197
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Not Applicable
//Comments
2.Phase of Disposition: Not Applicable Comments
3.Status: Not Applicable Comments
4.Specify Status: Not Applicable
[ ]Comments
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810875
Page 47 of 197
***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: 11471007 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:
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810876
Page 48 of 197
***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: 11471007 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 [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810877
Page 49 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Exposure during pre
gnancy Nov/UNK/2020 UN
K:UNK YES Repeating
Pages
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810878
Page 50 of 197
***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: 11471007 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)[Exposure during pregnancy]
4.Start Date Time: Nov/UNK/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: Not Applicable Comments
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810879
Page 51 of 197
***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: 11471007 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:
[Pregnancy]
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[ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810880
Page 52 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810881
Page 53 of 197
***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: 11471007 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[ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810882
Page 54 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medicati
onStart Da
teForm Instanc
e
1.1 VACCINATIONS
NO COVID-19 Vaccine
(Pfizer) Jan/18/2
021 Repeating
Pages
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810883
Page 55 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[COVID-19 Vaccine (Pfizer)]
5.Date: Jan/18/2021
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810884
Page 56 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810885
Page 57 of 197
***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: 11471007 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?
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810886
Page 58 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810887
Page 59 of 197
***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: 11471007 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?
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810888
Page 60 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810889
Page 61 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810890
Page 62 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810891
Page 63 of 197
***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: 11471007 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:
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810892
Page 64 of 197
***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: 11471007 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:
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810893
Page 65 of 197
***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: 11471007 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?
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810894
Page 66 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810895
Page 67 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810896
Page 68 of 197
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810897
Page 69 of 197
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810898
Page 70 of 197
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 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 [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810899
Page 71 of 197
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 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 [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810900
Page 72 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810901
Page 73 of 197
***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: 11471007 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 NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810902
Page 74 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810903
Page 75 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810904
Page 76 of 197
***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: 11471007 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: [ ]
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810905
Page 77 of 197
***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: 11471007 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 Sep/21/2020
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810906
Page 78 of 197
***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: 11471007 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
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810907
Page 79 of 197
***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: 11471007 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
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810908
Page 80 of 197
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormMar-08-2021 17:26:38 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810909
Page 81 of 197
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Mar-08-2021 17:26:38 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810910
Page 82 of 197
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Mar-08-2021 17:26:38 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810911
Page 83 of 197
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormMar-08-2021 17:27:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810912
Page 84 of 197
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Mar-08-2021 17:27:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810913
Page 85 of 197
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Mar-08-2021 17:27:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810914
Page 86 of 197
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Mar-08-2021 17:27:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810915
Page 87 of 197
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Mar-08-2021 17:27:16 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0810916
Page 88 of 197
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormMar-12-2021 07:52:26 (UTC-06:00) Central
Time (US & Canada)James
McMullenNot Applicable
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810917
Page 89 of 197
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Mar-12-2021 07:52:26 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Applicable
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810918
Page 90 of 197
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Mar-12-2021 07:52:26 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Applicable
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810919
Page 91 of 197
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
3Mar-12-2021 07:52:26 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Applicable
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810920
Page 92 of 197
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
4Mar-12-2021 07:52:26 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Applicable
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810921
Page 93 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
6Mar-10-2021 10:37:03 (UTC-06:00) Central
Time (US & Canada)James McMullen Not Applicable
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810922
Page 94 of 197
***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: 11471007 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-12-2021 10:36:28 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Julia
Garcia-Diaz Approved Oct-08-2020 20:41:12 (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 Sep-21-2020 11:05:33 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Julia
Garcia-Diaz Approved Sep-11-2020 13:59:36 (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.
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810923
Page 95 of 197
***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: 11471007 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
Aug-04-2020 09:09:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-04-2020 09:09:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810924
Page 96 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-04-2020 09:09:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/3/2020Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810925
Page 97 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-04-2020 09:09:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11471007Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-10-2020 03:36:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed DOB year updated
Aug-07-2020 08:47:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Aug-07-2020 08:47:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
/1984New Information
Aug-07-2020 04:02:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Opened PDQ: Subject's age
was 86 YEARS
when randomized
into the study.
Please confirm
whether the date of
birth entered is
correct. Also,
confirm whether
the subject has met
Inclusion criteria #
1. Please review
and update as
appropriate.
Otherwise, clarify.
Aug-04-2020 09:09:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc (autocalc) Data Entry:
/1934Enrollment Entry
3. Sex:
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810926
Page 98 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-04-2020 09:10:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-04-2020 09:10:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-04-2020 09:10:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d76\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-2021-5683-0810927
Page 99 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-04-2020 09:10:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/3/2020Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810928
Page 100 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion D
escrip
tion:Male or female participan
ts between the ages of 18
and 55 years, inclusive, 6
5 and 85 years, inclusive,
or 18 and 85 years, inclus
ive, at randomization (de
pendent upon study stage
)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Male or female participants betwe
en the ages of 18 and 55 years, in
clusive, 65 and 85 years, inclusiv
e, or 18 and 85 years, inclusive, atInitial Entry
090177e196ae3d76\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-2021-5683-0810929
Page 101 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
randomization (dependent upon st
udy stage)
1.a Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Des
criptio
n:Participants who are will
ing and able to comply w
ith all scheduled visits, v
accination plan, laborato
ry tests, lifestyle conside
rations, and other study p
rocedures
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN02A00Initial Entry
090177e196ae3d76\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-2021-5683-0810930
Page 102 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Inclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participants who are willing and a
ble to comply with all scheduled
visits, vaccination plan, laborator
y tests, lifestyle considerations, an
d other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:3Initial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810931
Page 103 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Criter
ion De
scripti
on:Healthy participants who
are determined by medic
al history, physical exam
ination, and clinical judg
ment of the investigator t
o be eligible for inclusio
n in the study
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810932
Page 104 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.c Inclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Healthy participants who are dete
rmined by medical history, physic
al examination, and clinical judg
ment of the investigator to be elig
ible for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810933
Page 105 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Criteri
on Des
criptio
n:Capable of giving person
al signed informed conse
nt, which includes compl
iance with the requireme
nts and restrictions listed
in the ICD and in this pr
otocol
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN04A00
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810934
Page 106 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d Inclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Capable of giving personal signed
informed consent, which includes
compliance with the requirements
and restrictions listed in the ICD a
nd in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion N
umber
:1Initial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810935
Page 107 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Criter
ion De
scripti
on:Other medical or psychia
tric condition incl. recent
(within past year) or acti
ve suicidal ideation/beha
vior/lab abnormality that
may increase the risk of s
tudy participation
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Other medical or psychiatric cond
ition incl. recent (within past year
) or active suicidal ideation/behav
ior/lab abnormality that may incre
ase the risk of study participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae3d76\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-2021-5683-0810936
Page 108 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Num
ber:2
Criterio
n Descri
ption:Known infection with
human immunodeficie
ncy virus (HIV), hepati
tis C virus (HCV), or h
epatitis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810937
Page 109 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.b Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Known infection with human im
munodeficiency virus (HIV), hep
atitis C virus (HCV), or hepatitis
B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810938
Page 110 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Criteri
on Des
criptio
n:History of severe advers
e reaction associated wit
h a vaccine and/or severe
allergic reaction (eg, ana
phylaxis) to any compon
ent of the study intervent
ion(s)
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810939
Page 111 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.c Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
History of severe adverse reaction
associated with a vaccine and/or s
evere allergic reaction (eg, anaph
ylaxis) to any component of the st
udy intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion N
umber:4
Criterion De
scription:Receipt of medicat
ions intended to pr
event COVID-19
Criterion m
et?:NOInitial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810940
Page 112 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Criterion ID
: (For Pfizer
use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of medications intended t
o prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:8Initial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810941
Page 113 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodefici
ency, as determined by h
istory and/or laboratory/
physical examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX08A00
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810942
Page 114 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.e Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Immunocompromised individuals
with known or suspected immuno
deficiency, as determined by histo
ry and/or laboratory/physical exa
minationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810943
Page 115 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Criteri
on Des
criptio
n:Bleeding diathesis or co
ndition associated with p
rolonged bleeding that w
ould, in the opinion of th
e investigator, contraindi
cate intramuscular inject
ion
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX10A00
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0810944
Page 116 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.f Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bleeding diathesis or condition as
sociated with prolonged bleeding
that would, in the opinion of the i
nvestigator, contraindicate intram
uscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion Nu
mber:11
Criterion Des
cription:Women who are
pregnant or brea
stfeeding
Criterion met
?:NOInitial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810945
Page 117 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Criterion ID:
(For Pfizer us
e only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Women who are pregnant or breas
tfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusion N
umber:12
Criterion De
scription:Previous vaccinati
on with any coron
avirus vaccineInitial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810946
Page 118 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Previous vaccination with any cor
onavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numb
er:13Initial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810947
Page 119 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive the
rapy, such as cytotoxic
agents or systemic cort
icosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Subjects who receive immunosup
pressive therapy, such as cytotoxi
c agents or systemic corticosteroi
dsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX13A01Initial Entry
090177e196ae3d76\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-2021-5683-0810948
Page 120 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.j
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclus
ion Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglob
ulin, from 60 days befor
e study intervention adm
inistration or planned rec
eipt throughout the study
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX14A01Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810949
Page 121 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.j Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Receipt of blood/plasma products
or immunoglobulin, from 60 days
before study intervention adminis
tration or planned receipt through
out the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX14A01Initial Entry
090177e196ae3d76\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-2021-5683-0810950
Page 122 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
2.k
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Desc
ription:Participation in other st
udies involving study i
ntervention within 28 d
ays prior to study entry
and/or during study par
ticipation
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX15A01Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810951
Page 123 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.k Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participation in other studies invo
lving study intervention within 2
8 days prior to study entry and/or
during study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Exclusio
n Numbe
r:17
Criterio
n Descri
ption:Previous participation
in other studies involv
ing study intervention
containing lipid nanop
articlesInitial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810952
Page 124 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Previous participation in other stu
dies involving study intervention
containing lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Exclu22Initial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810953
Page 125 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada) sion N
umbe
r:
Criter
ion De
scripti
on:Investigator site staff or
Pfizer employees directl
y involved in the conduct
of the study, site staff oth
erwise supervised by the
investigator, and their res
pective family members
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810954
Page 126 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.m Exclusion Number:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Investigator site staff or Pfizer e
mployees directly involved in the
conduct of the study, site staff oth
erwise supervised by the investig
ator, and their respective family
membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-04-2020 09:13:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EX21A01Initial Entry
090177e196ae3d76\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-2021-5683-0810955
Page 127 of 197
***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: 11471007 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
Aug-04-2020 09:13:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-04-2020 09:13:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-04-2020 09:13:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810956
Page 128 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Aug-04-2020 09:14:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:intermittent lumbosa
cral disc herniation
Start Date: UNK/UNK/2006
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-04-2020 09:14:33
(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
Aug-04-2020 09:14:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
intermittent lumbosacral disc hern
iationInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-04-2020 09:14:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2006Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-04-2020 09:14:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
090177e196ae3d76\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-2021-5683-0810957
Page 129 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-04-2020 09:14:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:menarche fem
ale
Start Date: UNK/UNK/1
996
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-04-2020 09:14:56
(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
Aug-04-2020 09:14:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
menarche femaleInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-04-2020 09:14:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-04-2020 09:14:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d76\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-2021-5683-0810958
Page 130 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Aug-04-2020 09:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-04-2020 09:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
104.3Initial Entry
3. Unit:
Date Location User Value Reason
Aug-04-2020 09:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-04-2020 09:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
172.7Initial Entry
5. Unit:
Date Location User Value Reason
Aug-04-2020 09:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-04-2020 09:16:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
35.0Initial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810959
Page 131 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.a
Date Location User Value Reason
Aug-04-2020 09:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.9
Temperature Unit
:C
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-04-2020 09:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-04-2020 09:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-04-2020 09:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-04-2020 09:16:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810960
Page 132 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-04-2020 09:16:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-04-2020 09:16:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-04-2020 09:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/3/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-04-2020 09:16:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-04-2020 09:16:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-04-2020 09:16:38
(UTC-06:00) Central TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810961
Page 133 of 197
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-04-2020 09:16:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-04-2020 09:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-04-2020 09:16:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810962
Page 134 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-04-2020 09:16:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-04-2020 15:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
40580Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810963
Page 135 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-04-2020 09:16:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-04-2020 09:16:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-05-2020 02:19:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Luke Cunliffe Query 3: Closed Response satisfies
query.
Aug-04-2020 16:22:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered missing barcodes
have been scanned
Aug-04-2020 14:40:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Luke Cunliffe Query 3: Opened Clinical review:
Subject has <5
aliquot barcodes
(expecting 5) and no
comment has been
added to explain the
low blood draw.
What is the reason
for the low number
of aliquots?
Aug-04-2020 09:18:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Aug-04-2020 09:17:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810964
Page 136 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
entered. Please
review and correct
as appropriate.
Aug-04-2020 09:17:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-04-2020 09:17:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/3/2020New Information
Aug-04-2020 09:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Sample Collected?'
is marked as No and
'If no sample was
collected or sample
was not collected
according to
protocol, please
provide reason' is
missing. Please
review and update
as appropriate.
Aug-04-2020 09:16:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Aug-04-2020 09:18:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPL417Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-04-2020 09:18:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPL417Initial Entry
5.b
090177e196ae3d76\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-2021-5683-0810965
Page 137 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-04-2020 09:18:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPL418Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-04-2020 09:18:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPL418Initial Entry
5.c
Date Location User Value Reason
Aug-04-2020 16:20:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM7Y2FInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-04-2020 16:20:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM7Y2FInitial Entry
5.d
Date Location User Value Reason
Aug-04-2020 16:21:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM7Y2GInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-04-2020 16:21:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM7Y2GInitial Entry
5.e
090177e196ae3d76\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-2021-5683-0810966
Page 138 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-04-2020 16:21:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM7Y2HInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-04-2020 16:21:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM7Y2HInitial Entry
5.f
Date Location User Value Reason
Aug-04-2020 16:21:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM7Y2JInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-04-2020 16:21:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM7Y2JInitial Entry
090177e196ae3d76\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-2021-5683-0810967
Page 139 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-04-2020 09:19:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-04-2020 09:19:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-04-2020 09:19:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-04-2020 09:19:21
(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.
Aug-04-2020 09:19:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/3/2020Initial Entry
5.a
Date Location User Value Reason
Aug-04-2020 09:19:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM7Y1GInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810968
Page 140 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Aug-04-2020 09:19:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM7Y1GInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810969
Page 141 of 197
***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: 11471007 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
Aug-04-2020 09:20:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-04-2020 09:20:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-04-2020 09:20:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-04-2020 09:20:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/3/2020 15:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-04-2020 09:20:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-04-2020 09:20:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d76\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-2021-5683-0810970
Page 142 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7. Route:
Date Location User Value Reason
Aug-04-2020 09:20:47
(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
Aug-04-2020 09:20:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-04-2020 09:20:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810971
Page 143 of 197
***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: 11471007 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
Aug-04-2020 09:20:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810972
Page 144 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-24-2020 11:29:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810973
Page 145 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-27-2020 10:20:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
Symptom:: FATIGUEChanged
Information
090177e196ae3d76\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) (4)
FDA-CBER-2021-5683-0810974
Page 146 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:YES
Ongoing
?
NO
Stop
Date:
Au
g/1
0/2
020
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0810975
Page 147 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.b Symptom:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 07:44:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-27-2020 10:20:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Aug-27-2020 10:20:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
YES
Ongoing?
NO
Stop Date:
Aug/10/2020Changed
Information
Aug-25-2020 04:48:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened e-Diary: Per eDiary
records, FATIGUE
is reported on Last
day (Day 7)
however the last
day in inform is
entered as 'No' for
the same. Please
verify and update.
Else, clarify.
Thanks.
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
090177e196ae3d76\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) (4)
FDA-CBER-2021-5683-0810976
Page 148 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3d76\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-2021-5683-0810977
Page 149 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.d Symptom:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810978
Page 150 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d76\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-2021-5683-0810979
Page 151 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.g Symptom:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810980
Page 152 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
3. Injection Site Location:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
090177e196ae3d76\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-2021-5683-0810981
Page 153 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
090177e196ae3d76\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-2021-5683-0810982
Page 154 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-24-2020 11:31:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810983
Page 155 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Aug-24-2020 11:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2.a
Date Location User Value Reason
Aug-24-2020 11:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.6
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-24-2020 11:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-24-2020 11:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.6Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-24-2020 11:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3d76\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)
FDA-CBER-2021-5683-0810984
Page 156 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - 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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.a Temperature Location:
Date Location User Value Reason
Aug-24-2020 11:32:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810985
Page 157 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-24-2020 11:33:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-24-2020 11:33:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-24-2020 11:33:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-24-2020 11:33:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-24-2020 11:33:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-24-2020 11:33:03
(UTC-06:00) Central TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810986
Page 158 of 197
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-24-2020 11:33:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-24-2020 11:33:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-24-2020 11:33:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810987
Page 159 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020 11:33:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 11:33:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020 10:03:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-25-2020 07:17:22
(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.
Aug-24-2020 11:33:11
(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.
Aug-24-2020 11:33:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810988
Page 160 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-25-2020 10:03:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY322Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-25-2020 10:03:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY322Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810989
Page 161 of 197
***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: 11471007 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
Aug-24-2020 11:33:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-24-2020 11:33:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020 11:33:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-24-2020 11:33:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020 10:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-24-2020 11:33:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-24-2020 11:33:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d76\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-2021-5683-0810990
Page 162 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7. Route:
Date Location User Value Reason
Aug-24-2020 11:33:33
(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
Aug-24-2020 11:33:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-24-2020 11:33:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0810991
Page 163 of 197
***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: 11471007 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-03-2020 13:09:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-02-2020 13:39:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenQuery 1: Answered Per protocol,
symptoms reported
within 7 days of
injection does not
trigger a COVID
visit. Subject
reported “YES”
within 7 days of
injection.
Oct-02-2020 07:23:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened As per Illness
ediary records,
subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
28SEP2020. But
there is no COVID
Illness visit reported
in the database.
Please clarify.
Sep-21-2020 11:05:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
Sep/21/2020Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b)
(4),
(b)(6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810992
Page 164 of 197
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
Symptom:: FA
TIG
UEInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810993
Page 165 of 197
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810994
Page 166 of 197
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.c Symptom:
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810995
Page 167 of 197
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810996
Page 168 of 197
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.f Symptom:
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NOInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810997
Page 169 of 197
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.h
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-21-2020 11:17:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0810998
Page 170 of 197
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-21-2020 11:17:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTTranscription Error
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Injection Site Body
Side entered on this
page is not matching
with Body Side
entered on
Vaccination page of
V2VX2L. Please
review and update
as appropriate.
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NOInitial Entry
090177e196ae3d76\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-2021-5683-0810999
Page 171 of 197
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.b
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811000
Page 172 of 197
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-21-2020 11:06:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
NOInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811001
Page 173 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-21-2020 11:06:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 11:06:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020 09:26:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-22-2020 01:46:08
(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-21-2020 11:06:50
(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.
Sep-21-2020 11:06:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Fredrick
OkworiData Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
5.a
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811002
Page 174 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-22-2020 09:26:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY3K2Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 09:26:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY3K2Initial Entry
5.b
Date Location User Value Reason
Sep-22-2020 09:26:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPY3K3Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-22-2020 09:26:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPY3K3Initial Entry
5.c
Date Location User Value Reason
Sep-22-2020 09:30:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLF6LInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-22-2020 09:30:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLF6LInitial Entry
5.d
090177e196ae3d76\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-2021-5683-0811003
Page 175 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Sep-22-2020 09:41:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPLF66Initial Entry
5.d Sample ID
Date Location User Value Reason
Sep-22-2020 09:41:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPLF66Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811004
Page 176 of 197
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021 17:26:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-08-2021 17:26:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811005
Page 177 of 197
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021 17:27:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021 17:27:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021 17:27:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Mar-08-2021 17:27:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3d76\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-2021-5683-0811006
Page 178 of 197
***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: 11471007 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-02-2020 12:38:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-02-2020 12:38:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-02-2020 12:38:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0811007
Page 179 of 197
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 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
Mar-12-2021 07:52:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-12-2021 07:51:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry: Changed
Information
Mar-08-2021 17:35:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-12-2021 07:52:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Mar-12-2021 07:51:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Changed
Information
Mar-08-2021 17:35:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Mar-12-2021 09:52:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Closed Response satisfies
query
Mar-12-2021 07:52:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-12-2021 07:52:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed
Information
090177e196ae3d76\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-2021-5683-0811008
Page 180 of 197
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-12-2021 07:52:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry: Changed
Information
Mar-12-2021 01:33:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened CLINQUERY: Page
update needed per
query response -
subject remaining on
trial
Mar-11-2021 15:17:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Reissued:Candidate CLINQUERY: Page
update needed per
query response -
subject remaining on
trial
Mar-11-2021 07:43:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenQuery 2: Answered Subject not
discontinued from
study. Site is now
aware that the
subject may stay in
study in which the
subject has agreed
to. Please unfreeze
Mar-11-2021 07:20:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 2: Opened CLINQUERY: FUP
(end of study) is
reported to be linked
to pregnancy.
However, the AE
entry for pregnancy
is not marked as
'yes' for the question
'Did the adverse
event cause the
subject to be
discontinued from
the study?'. Please
review entries
Mar-08-2021 17:38:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-08-2021 17:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Status"
is PREGNANCY
but "Specify Status"
is Provided.
090177e196ae3d76\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-2021-5683-0811009
Page 181 of 197
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-08-2021 17:35:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PREGNANCYInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-12-2021 07:52:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
Not ApplicableInitial Entry
Mar-08-2021 17:38:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Mar-08-2021 17:37:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
At REVAX CONT and at unblin
ding pt was eligible for Vax#3 b
ut later met excl. #11 per prot#1
2Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811010
Page 182 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenForm Created
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811011
Page 183 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-10-2021 10:36:43
(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
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
Exposure during pregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-10-2021 10:37:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-10-2021 10:37:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
Nov/UNK/2020 UNK:UNKTranscription Error
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For Exposure
during pregnancy
Start Date
UNK/Nov/2021, is
a future date relative
to when it was
entered on 10/Mar
/2021. Please
correct.
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811012
Page 184 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
Nov/UNK/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021 07:51:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Answer Auto Query
Mar-10-2021 13:46:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate reached out to Triad
Team to discuss
with CTM/CRA to
help site FUP does
not need to be
completed for
pregnancy
Mar-10-2021 10:37:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenQuery 1: Answered Pregnancy still
ongoing
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is
still ongoing. Please
review and update
as appropriate.
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-10-2021 10:37:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
Not ApplicableInitial 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
090177e196ae3d76\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-2021-5683-0811013
Page 185 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-10-2021 13:11:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-10-2021 10:38:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenQuery 2: Answered Details correct
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least
one seriousness
criteria is missing.
Please review and
update as
appropriate.
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Exposure
during pregnancy :
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require
or prolong hospitalization?
NOInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811014
Page 186 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
PregnancyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
NOInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811015
Page 187 of 197
***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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-10-2021 10:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
NOInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811016
Page 188 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-22-2021 13:32:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenForm Created
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811017
Page 189 of 197
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Feb-22-2021 13:32:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Feb-22-2021 13:32:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Feb-22-2021 13:32:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown, enter
the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route, use,
formulation).
Date Location User Value Reason
Feb-22-2021 13:32:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
COVID-19 Vaccine (Pfizer)Initial Entry
5. Date:
Date Location User Value Reason
Feb-22-2021 13:32:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
Jan/18/2021Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811018
Page 190 of 197
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-12-2021 10:45:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/22/2020Transcription Error
Feb-12-2021 10:40:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/21/2020Transcription Error
Feb-12-2021 10:36:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/12/2021Initial Entry
090177e196ae3d76\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-2021-5683-0811019
Page 191 of 197
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-08-2021 05:13:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-05-2021 12:56:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed
Information
Mar-05-2021 12:56:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenData Entry:
Participant is NOT willing to re
turn for Vaccination 3 OR other
wise not eligibleChanged
Information
Mar-05-2021 12:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Form is
unfrozen.Please
review and update as
appropriate
Mar-05-2021 08:48:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 James
McMullenQuery 2: Answered Please unfreeze. The
subject is not
eligible
Mar-05-2021 01:46:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Participant is
eligible and
confirmed to have
received Placebo,
but Date Written
Consent Obtained is
missing in Informed
Consent - Further
Vaccination CRF.
Please review and
update as
appropriate.
Feb-12-2021 10:44:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-12-2021 10:36:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811020
Page 192 of 197
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-12-2021 10:36:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per other protocol al
lowance(s) and confirmed to
have received only placebo a
t Vaccination 1/2Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0811021
Page 193 of 197
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - 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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-12-2021 10:44:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/11/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Mar-09-2021
10:36:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Rivkah Rosen Query
1: Clo
sedResponse satisfies
query
Mar-08-2021
17:39:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dAt REVAX CONT and
at unblinding pt was
eligible for Vax#3 but
later met excl. #11 per
prot#12 as reported in
FUP disposition
Mar-05-2021
22:09:44
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7624465;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Feb-12-2021
10:44:17
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Data
Entry
:
ASSE
SS ELInitial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b)
(4),
(b)(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0811022
Page 194 of 197
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - 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: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Canada) IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ON
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811023
Page 195 of 197
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-12-2021 07:52:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPChanged
Information
Mar-09-2021 04:48:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-08-2021 17:39:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered visit 4 updated as
not done
Mar-08-2021 17:35:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Mar-08-2021 06:33:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Visit 4 is
overdue based on
expected visit
window. Please
enter data or, if visit
will never occur,
mark Date of Visit
as ‘Not Done’ with
form level
comment. If subject
is no longer in the
trial, complete the
Disposition FUP
form.
Oct-02-2020 12:38:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-04-2020 09:16:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-04-2020 09:13:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
090177e196ae3d76\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-2021-5683-0811024
Page 196 of 197
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1147 Site Name: (1147) Ochsner Health System
Subject No: 11471007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2. Subject Status Date
Date Location User Value Reason
Mar-12-2021 07:52:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/21/2020Changed
Information
Mar-12-2021 07:51:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/21/2020Changed
Information
Mar-08-2021 17:35:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Feb/17/2021Initial Entry
Oct-02-2020 12:38:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/21/2020Initial Entry
Aug-04-2020 09:16:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/3/2020Initial Entry
Aug-04-2020 09:13:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/3/2020Initial Entry
090177e196ae3d76\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0811025
Page 197 of 197
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail H
…[truncated]