125742 45 S211 M5 c4591001 1009 10091221

Document text

Page 1 of 251
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version06 OCT 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493418
Page 2 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/19/2020
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493419
Page 3 of 251
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [10091221]
2.Birth Date: 2006
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:
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0493420
Page 4 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493421
Page 5 of 251
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493422
Page 6 of 251
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493423
Page 7 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BILATERAL KNEE PAIN]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BILATERAL ANKLE PAIN]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[BILATERAL HIP PAIN]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493424
Page 8 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[TONSILLITIS]
Start Date: Aug/10/2017
Ongoing: NO
End Date:
Apr/UNK/2019
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[premenarchal]
Start Date: 2006
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[facial acne]
Start Date: Feb/UNK/2020
Ongoing: YES
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0493425
Page 9 of 251
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493426
Page 10 of 251
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/19/2020
2.Weight: [105.0]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [18.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493427
Page 11 of 251
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493428
Page 12 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/19/2020
2.Randomization Number: [20134]
3.Randomization Group: [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493429
Page 13 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BR9FM9]
5.bSample ID [BR9FM4]
5.cSample ID [BKYCTC]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493430
Page 14 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BP9GCC]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493431
Page 15 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/19/2020 13:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493432
Page 16 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493433
Page 17 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/7/2020
2.Erroneous Visit
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493434
Page 18 of 251
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?YES
Ongoing?
NO
Stop Date:
Oct/23/2020
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493435
Page 19 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493436
Page 20 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?YES
Ongoing?
NO
Stop Date:
Oct/23/2020
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493437
Page 21 of 251
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Nov/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493438
Page 22 of 251
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and
Address (Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493439
Page 23 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/7/2020
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 [BGGZY1]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493440
Page 24 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/7/2020 11:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493441
Page 25 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493442
Page 26 of 251
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493443
Page 27 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493444
Page 28 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493445
Page 29 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/10/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR5BGJ]
5.bSample ID [BR5BGH]
5.cSample ID [BSJ3LJ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493446
Page 30 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/14/2021
2.Erroneous Visit
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493447
Page 31 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
May/14/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BTLHCK]
5.bSample ID [BTLHCL]
5.cSample ID [BRTSSY]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493448
Page 32 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493449
Page 33 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493450
Page 34 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493451
Page 35 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493452
Page 36 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493453
Page 37 of 251
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493454
Page 38 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493455
Page 39 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493456
Page 40 of 251
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493457
Page 41 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493458
Page 42 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493459
Page 43 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493460
Page 44 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493461
Page 45 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493462
Page 46 of 251
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/20/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493463
Page 47 of 251
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/20/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493464
Page 48 of 251
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/20/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Oct/20/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493465
Page 49 of 251
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493466
Page 50 of 251
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 30-Apr-2021 01:41 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493467
Page 51 of 251
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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:
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493468
Page 52 of 251
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493469
Page 53 of 251
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493470
Page 54 of 251
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493471
Page 55 of 251
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/9/2021
2.Erroneous Visit
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493472
Page 56 of 251
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Apr/9/2021
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493473
Page 57 of 251
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Apr/9/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRTSPB]
5.bSample ID [BR9DNK]
5.cSample ID [BR9DNL]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493474
Page 58 of 251
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Apr/9/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9DTR]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493475
Page 59 of 251
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493476
Page 60 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/13/2021
2.Erroneous Visit
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493477
Page 61 of 251
***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, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is NOT willing to return for Vaccination 3 OR
otherwise not eligible
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493478
Page 62 of 251
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493479
Page 63 of 251
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  worsening right
ankle pain Oct/19/202
0 17:00 NO
End Date Time:
Oct/19/2020 UNK:
UNK
 Repeating
Pages
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493480
Page 64 of 251
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[worsening right ankle pain]
4.Start Date Time: Oct/19/2020 17:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/19/2020 UNK:UNK
6.Toxicity Grade: 3
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493481
Page 65 of 251
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[dance injury]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493482
Page 66 of 251
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493483
Page 67 of 251
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493484
Page 68 of 251
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493485
Page 69 of 251
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493486
Page 70 of 251
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493487
Page 71 of 251
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493488
Page 72 of 251
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493489
Page 73 of 251
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493490
Page 74 of 251
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493491
Page 75 of 251
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493492
Page 76 of 251
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493493
Page 77 of 251
***Confidential***
 
Header Text: c4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill
Family Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493494
Page 78 of 251
***Confidential***
 
Header Text: c4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 13-Apr-2021 01:26 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill
Family Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493495
Page 79 of 251
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Apr/18/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/18/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493496
Page 80 of 251
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Apr/18/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Apr/18/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA45840]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493497
Page 81 of 251
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Apr/28/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/28/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493498
Page 82 of 251
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Apr/28/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Apr/28/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA45841]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493499
Page 83 of 251
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on May/09/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/9/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK6
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493500
Page 84 of 251
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on May/09/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
May/9/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA45844]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493501
Page 85 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : May/13/2021
2.Primary Reason for
Unblinding:OTHER
If other, specify:
[parent preference]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493502
Page 86 of 251
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493503
Page 87 of 251
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493504
Page 88 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/10/2020
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493505
Page 89 of 251
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493506
Page 90 of 251
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493507
Page 91 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormOct-19-2020 15:55:11 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493508
Page 92 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormOct-19-2020 15:59:29 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493509
Page 93 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Oct-19-2020 15:59:29 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493510
Page 94 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Oct-19-2020 15:59:29 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493511
Page 95 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Oct-19-2020 15:59:29 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493512
Page 96 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Oct-19-2020 15:59:29 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493513
Page 97 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Oct-19-2020 15:59:29 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493514
Page 98 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aOct-19-2020 15:59:29 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493515
Page 99 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aOct-19-2020 15:59:29 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493516
Page 100 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aOct-19-2020 15:59:29 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493517
Page 101 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormNov-07-2020 11:28:03 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493518
Page 102 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Nov-07-2020 11:28:03 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493519
Page 103 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Nov-07-2020 11:28:03 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493520
Page 104 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Nov-07-2020 11:28:03 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493521
Page 105 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Nov-07-2020 11:28:03 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493522
Page 106 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Nov-07-2020 11:28:03 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493523
Page 107 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aNov-07-2020 11:28:03 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493524
Page 108 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aNov-07-2020 11:28:03 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493525
Page 109 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6.aNov-07-2020 11:28:03 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493526
Page 110 of 251
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Apr-20-2021 09:30:22 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Apr-13-2021 17:10:38 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, 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.
 N/A Apr-09-2021 14:39:55 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0493527
Page 111 of 251
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
N/A
 Approved Mar-09-2021 21:31:14 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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.
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0493528
Page 112 of 251
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-19-2020
15:54:27
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-19-2020
15:54:27
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493529
Page 113 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-19-2020
15:54:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Oct/19/2020Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493530
Page 114 of 251
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-19-2020
15:54:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
10091221Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-19-2020
15:54:01
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2006Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-19-2020
15:54:49
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493531
Page 115 of 251
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Oct-19-2020
15:54:49
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-19-2020
15:54:49
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
WHITEInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493532
Page 116 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020
15:55:01
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Oct/19/2020Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493533
Page 117 of 251
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-19-2020
15:55:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020
15:55:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020
15:55:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493534
Page 118 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.a
Date Location User Value Reason
Oct-19-2020
15:56:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:BILATERAL
KNEE PAIN
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-19-2020
15:56:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-03-2020
17:43:23
(UTC-07:00)
Mountain Time (USACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493535
Page 119 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada)
Oct-31-2020
11:13:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered Changed data per
query
Oct-26-2020
08:02:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Luke
CunliffeQuery 1: Reissued:Opened All female
subjects of
childbearing
potential should
have a UPT
included as a
pre-vaccination
procedure. For
adolescents that
are not of
childbearing
potential,
‘premenarchal’
should be added
to medical
history. Thank
you.
Oct-23-2020
12:04:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered not usually
captured in
medical history
as absence of a
period is a
normal state for
children. I will
double check
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493536
Page 120 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Oct-21-2020
19:30:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Opened ClinQuery:
Please confirm if
pt is
premenarchal if
so please could
this be added to
the Med Hx CRF
Oct-19-2020
15:56:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BILATERAL KNEE PAINInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-19-2020
15:56:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-19-2020
15:56:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493537
Page 121 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.b
Date Location User Value Reason
Oct-19-2020
15:56:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:BILATERAL
ANKLE PAIN
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493538
Page 122 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.b Line/MH Number:
Date Location User Value Reason
Oct-19-2020
15:56:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020
15:56:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BILATERAL ANKLE PAINInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-19-2020
15:56:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493539
Page 123 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Oct-19-2020
15:56:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-19-2020
15:57:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:BILATERAL
HIP PAIN
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493540
Page 124 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.c Line/MH Number:
Date Location User Value Reason
Oct-19-2020
15:57:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020
15:57:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BILATERAL HIP PAINInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-19-2020
15:57:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493541
Page 125 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Oct-19-2020
15:57:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-19-2020
15:57:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histo
ry Term:TONSILLIT
IS
Start Date: Aug/10/2017
Ongoing: NO
End Date:
Apr/UNK
/2019Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493542
Page 126 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.d Line/MH Number:
Date Location User Value Reason
Oct-19-2020
15:57:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020
15:57:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
TONSILLITISInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-19-2020
15:57:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Aug/10/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493543
Page 127 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Oct-19-2020
15:57:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NO
End Date:
Apr/UNK/2019Initial Entry
1.e
Date Location User Value Reason
Oct-31-2020 11:13:22
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:premenarc
hal
Start Date: 200
6
Ongoing: YESInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493544
Page 128 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.e Line/MH Number:
Date Location User Value Reason
Oct-31-2020 11:13:22
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-24-2020
09:02:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Nov-23-2020
09:38:45
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered Changed data
per query
Nov-20-2020
14:08:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Opened Sorry no where
else to put this
query. Subject
reported Facial
Acne start date
UNK/FEB
/2020. Please
confirm or
clarify.
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493545
Page 129 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Oct-31-2020
11:13:22
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
premenarchalInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-31-2020
11:13:22
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
/2006Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-31-2020
11:13:22
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Nov-23-2020
09:38:34
(UTC-07:00)
Mountain Time (USACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493546
Page 130 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada) Medical History
Term:facial acne
Start Date: Feb/UNK/
2020
Ongoing: YES
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493547
Page 131 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.f Line/MH Number:
Date Location User Value Reason
Nov-23-2020
09:38:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-23-2020
09:38:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
facial acneInitial Entry
1.f Start Date:
Date Location User Value Reason
Nov-23-2020
09:38:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/UNK/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493548
Page 132 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Nov-23-2020
09:38:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493549
Page 133 of 251
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-19-2020
15:58:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
The subject is NOT known to
be HIV POSITIVEInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493550
Page 134 of 251
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-19-2020
15:59:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Oct/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-19-2020
15:59:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
105.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-19-2020
15:59:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
LBInitial Entry
4. Height:
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493551
Page 135 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Oct-19-2020
15:59:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-19-2020
15:59:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-19-2020
15:59:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
18.0Initial Entry
7.a
Date Location User Value Reason
Oct-19-2020
15:59:12
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
Record Identifi 1Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493552
Page 136 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)er::
Temperature: 98.1
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITY
7.a Record Identifier:
Date Location User Value Reason
Oct-19-2020
15:59:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-19-2020
15:59:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-19-2020
15:59:12
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493553
Page 137 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)
7.a Temperature Location:
Date Location User Value Reason
Oct-19-2020
15:59:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493554
Page 138 of 251
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-19-2020
15:59:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-19-2020
15:59:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-03-2020
15:05:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Luke Cunliffe Query 1: Closed Response
satisfies query
Oct-31-2020
11:13:46ACV0PF
EINFP60Query 1: Answered Changed data
per query
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493555
Page 139 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00 
Oct-26-2020
08:01:01
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Luke Cunliffe Query 1: Reissued:Open
edPlease add
'premenarchal' to
medical history
CRF. For
adolescents that
are not of
childbearing
potential,
‘premenarchal’
should be added
to medical
history and a
UPT is not
required. Thank
you.
Oct-23-2020
12:03:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered patient
premenarchal
Oct-22-2020
14:27:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Opened Clinical review:
Please specify
why a pregnancy
test was not
performed. It is
not clear from
the subject’s
medical history
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493556
Page 140 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
and age (under
60 years) that
they are not of
childbearing
potential. Please
refer to protocol
section 10.4.3
WOCBP for
guidance.
Oct-22-2020
14:18:06
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Luke Cunliffe Query 1: Candidate Clinical review:
Please specify
why a pregnancy
test was not
performed. It is
not clear from
the subject’s
medical history
and age (under
60 years) that
they are not of
childbearing
potential. Please
refer to protocol
section 10.4.3
WOCBP for
guidance.
Oct-19-2020
15:59:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493557
Page 141 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-19-2020
15:59:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-19-2020
15:59:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-19-2020
15:59:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sponsor-Defined
Identifier:Not Appl
icable
Test:: Not Appl
icable
Result:: Not Appl
icable
Not Done:: Not Appl
icableInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493558
Page 142 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
6.a Sponsor ID:
Date Location User Value Reason
Oct-19-2020
15:59:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-19-2020
15:59:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-19-2020
15:59:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493559
Page 143 of 251
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Oct-19-2020
15:59:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493560
Page 144 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-19-2020
15:59:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Oct/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-19-2020
15:59:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
20134Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493561
Page 145 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020
16:03:42
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
16:03:42
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
16:04:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
16:03:42ACV0PF
EINFP60auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493562
Page 146 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00  Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-19-2020
16:03:42
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
16:04:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR9FM9Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
16:04:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BR9FM9Initial Entry
5.b
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493563
Page 147 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Oct-19-2020
16:05:21
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR9FM4Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020
16:05:21
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BR9FM4Initial Entry
5.c
Date Location User Value Reason
Oct-19-2020
16:05:42
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BKYCTCInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493564
Page 148 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Sample ID
Date Location User Value Reason
Oct-19-2020
16:05:42
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BKYCTCInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493565
Page 149 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-19-2020
16:02:44
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-19-2020
16:02:44
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020
16:02:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
16:02:44ACV0PF
EINFP60auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493566
Page 150 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00  Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-19-2020
16:02:44
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Oct/19/2020Initial Entry
5.a
Date Location User Value Reason
Oct-19-2020
16:02:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BP9GCCInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020
16:02:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BP9GCCInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493567
Page 151 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-19-2020
16:00:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-19-2020
16:00:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-19-2020
16:00:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493568
Page 152 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Oct-26-2020
00:23:45
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: Closed UNPL updated
Oct-23-2020
11:39:21
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: Answered Changed data per
query
Oct-22-2020
01:15:22
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: Reissued:
OpenedPDQ RQ1: Thank
you for confirming
subject was
contacted. Subjects
experiencing Grade
3
symptoms/reactions
should be
contacted. Per
CCR, please
consider updating
UNPLANNED
VISIT form and
select appropriate
Contact Outcome
option present on
UNPLANNED
VISIT.
Oct-21-2020
10:11:15
(UTC-07:00)
Mountain TimeACV0PF
EINFP60
00 Query 1: Answered subject was
contacted, no
unplanned visit was
deemed necessary
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493569
Page 153 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(US & Canada)
Oct-21-2020
03:28:35
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy PFE SDQ PROD Query 1: Opened PDQ: Subject has
reported with
Severe
symptoms/reactions
on '2020-10-19'.
Per protocol,
subjects
experiencing Grade
3 local reactions
should be
contacted. Please
confirm if an
UNPLANNED
CONTACT was
made and update
the corresponding
form as
appropriate.
Oct-19-2020
16:00:26
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PF
EINFP60
00 Data Entry:
Oct/19/2020 13:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-19-2020
16:00:26ACV0PF
EINFP60auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493570
Page 154 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00 
6. Body Side:
Date Location User Value Reason
Oct-19-2020
16:00:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-19-2020
16:00:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-19-2020
16:00:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493571
Page 155 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
investigational product administration?
Date Location User Value Reason
Oct-19-2020
16:00:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493572
Page 156 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-19-2020
16:00:36
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED FO
R THIS SUBJECTInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493573
Page 157 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-07-2020
10:59:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Nov/7/2020Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493574
Page 158 of 251
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020
11:27:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493575
Page 159 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?
:NOInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493576
Page 160 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HEADA
CHEInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493577
Page 161 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:YES
Ongoin
g?
NO
Stop
Date
:
Oct
/23
/20
20
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493578
Page 162 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Ongoing?
NO
Stop Date:
Oct/23/2020Initial Entry
2.d
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
SInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493579
Page 163 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
O
2.d Symptom:
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (USACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TINInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493580
Page 164 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada) G
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NO
2.e Symptom:
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-07-2020
11:27:23ACV0PF
EINFP60Data Entry:
Symptom:: DIInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493581
Page 165 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00  AR
RH
EA
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NO
2.f Symptom:
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493582
Page 166 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED MU
SCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493583
Page 167 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.h
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:NOInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493584
Page 168 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.h Symptom:
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-07-2020
11:27:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493585
Page 169 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493586
Page 170 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::SW
ELL
ING
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493587
Page 171 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site R
eaction::PAIN AT I
NJECTIO
N SITEInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493588
Page 172 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were injection
site reactions pr
esent on the last
day the Subject
Diary was com
pleted?:YES
Ongoing
?
NO
Stop
Date:
Oct/
23/2
020
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493589
Page 173 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 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
Nov-07-2020
11:27:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Ongoing?
NO
Stop Date:
Oct/23/2020Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493590
Page 174 of 251
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Nov-07-2020
11:27:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Nov/7/2020Initial Entry
2.a
Date Location User Value Reason
Nov-07-2020
11:27:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identifi
er::1
Temperature: 98.7
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-07-2020
11:27:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493591
Page 175 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.a Temperature:
Date Location User Value Reason
Nov-07-2020
11:27:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
98.7Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-07-2020
11:27:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-07-2020
11:27:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493592
Page 176 of 251
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-07-2020
11:28:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-07-2020
11:28:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-07-2020
11:28:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493593
Page 177 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Nov-07-2020
11:28:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-07-2020
11:28:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Nov-07-2020
11:28:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sponsor-Defined Id
entifier:Not D
one
Test:: Not D
one
Result:: Not D
one
Not Done:: Not D
oneInitial Entry
6.a Sponsor ID:
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493594
Page 178 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Nov-07-2020
11:28:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Nov-07-2020
11:28:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Nov-07-2020
11:28:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Nov-07-2020
11:28:03
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
Not DoneInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493595
Page 179 of 251
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493596
Page 180 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-07-2020
11:00:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-07-2020
11:00:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-07-2020
11:00:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-07-2020
11:00:29ACV0PF
EINFP60auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493597
Page 181 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00  Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Nov-07-2020
11:00:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Nov/7/2020Initial Entry
5.a
Date Location User Value Reason
Nov-07-2020
11:00:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BGGZY1Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-07-2020
11:00:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BGGZY1Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493598
Page 182 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-07-2020
11:31:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-07-2020
11:31:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-07-2020
11:31:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493599
Page 183 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Nov-07-2020
11:31:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Nov/7/2020 11:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-07-2020
11:31:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-07-2020
11:31:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-07-2020
11:31:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493600
Page 184 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-07-2020
11:31:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-07-2020
11:31:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493601
Page 185 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-01-2021
01:13:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Jan-29-2021
14:51:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered Changed data
per query
Jan-27-2021
04:25:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Opened DM: The
treatment period
is defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination.
Please complete
treatment
disposition CRF
and update date
of EOT to match
date of visit at
visit 3.
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493602
Page 186 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-25-2021
13:05:46
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/10/2020Transcription
Error
Jan-25-2021
13:04:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/25/2021Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493603
Page 187 of 251
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493604
Page 188 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?
:NOInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493605
Page 189 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493606
Page 190 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NO
2.c Symptom:
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HIInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493607
Page 191 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)LL
S
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
O
2.d Symptom:
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-25-2021
13:05:05ACV0PF
EINFP60Data Entry:
Symptom:: VOInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493608
Page 192 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00  MI
TIN
G
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NO
2.e Symptom:
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493609
Page 193 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493610
Page 194 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:NOInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493611
Page 195 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.g Symptom:
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED MU
SCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AINInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493612
Page 196 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:NO
2.h Symptom:
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Jan-25-2021 13:05:05
(UTC-07:00)ACV0PF
EINFP60auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493613
Page 197 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)00 
4. Injection Site Body Side:
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-25-2021
13:05:05ACV0PF
EINFP60Data Entry:
REDNESSInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493614
Page 198 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00 
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::SW
ELL
ING
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493615
Page 199 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reac
tion::PAIN
AT INJ
ECTI
ON SI
TEInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493616
Page 200 of 251
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 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
Jan-25-2021
13:05:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493617
Page 201 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-25-2021 13:05:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-25-2021 13:05:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-25-2021
13:06:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Jan-25-2021
13:06:07
(UTC-07:00)
Mountain Time (USACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493618
Page 202 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada)
Jan-25-2021
13:06:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Dec/10/2020Transcription
Error
Jan-25-2021
13:05:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Jan-25-2021
13:05:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Date of
Assessment is a
future date
relative to when
it was entered.
Please correct.
Jan-25-2021
13:05:26
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Dec/10/2021Initial Entry
5.a
Date Location User Value Reason
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493619
Page 203 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-25-2021
13:06:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR5BGJInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-25-2021
13:06:56
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BR5BGJInitial Entry
5.b
Date Location User Value Reason
Jan-25-2021
13:09:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR5BGHInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493620
Page 204 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Jan-25-2021
13:09:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BR5BGHInitial Entry
5.c
Date Location User Value Reason
Jan-25-2021
13:09:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BSJ3LJInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-25-2021
13:09:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BSJ3LJInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493621
Page 205 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
May-14-2021
15:31:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
May/14/2021Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493622
Page 206 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
May-14-2021
15:31:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
May-14-2021
15:31:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
May-14-2021
15:31:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
May-14-2021
15:31:33ACV0PF
EINFP60auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493623
Page 207 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00  Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
May-14-2021
15:31:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
May/14/2021Initial Entry
5.a
Date Location User Value Reason
May-14-2021
15:31:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BTLHCKInitial Entry
5.a Sample ID
Date Location User Value Reason
May-14-2021
15:31:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BTLHCKInitial Entry
5.b
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493624
Page 208 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
May-14-2021
15:32:01
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BTLHCLInitial Entry
5.b Sample ID
Date Location User Value Reason
May-14-2021
15:32:01
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BTLHCLInitial Entry
5.c
Date Location User Value Reason
May-14-2021
15:32:20
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRTSSYInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493625
Page 209 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Sample ID
Date Location User Value Reason
May-14-2021
15:32:20
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BRTSSYInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493626
Page 210 of 251
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/20/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-24-2020
09:02:20
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Nov-23-2020
09:39:04
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered Transcription
Error
Nov-23-2020
09:39:04
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Oct/20/2020Transcription
Error
Nov-20-2020
14:10:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Opened Per source
documents date
of visit is
20/OCT/2020.
Please confirm
or clarify.
Oct-23-2020
11:36:57
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
Oct/21/2020Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493627
Page 211 of 251
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/20/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493628
Page 212 of 251
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/20/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Assessments
Date Location User Value Reason
Oct-23-2020
11:38:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-23-2020
11:38:32
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Contact
Outcome is
ticked however
'CONTACT
OUTCOME'
form is not
entered. Please
review and
update as
appropriate.
Oct-23-2020
11:38:32
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493629
Page 213 of 251
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/20/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Contact Type:
Date Location User Value Reason
Oct-23-2020 11:38:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Nov-25-2020
02:54:36
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Date of Contact
is updated as
Date of Visit
20/Oct/2020.
Nov-24-2020
10:27:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered Answer Auto
Query
Nov-24-2020
10:27:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Contact:
Oct/20/2020
Contact Outcome:Transcription
Error
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493630
Page 214 of 251
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/20/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
VISIT NOT REQUIRE
D, INVESTIGATOR D
ECISION
Nov-23-2020
21:48:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Reissued:Opene
dDM : Form is
unfrozen now.
Date of Contact
21/Oct/2020 is
not equal to the
Date of Visit
20/Oct/2020
within same
unplanned visit.
Please review
and update as
appropriate.
Nov-23-2020
09:41:02
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered please unfreeze
and I will update
to 10/20/20
Nov-23-2020
09:39:04
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Date of Contact
21/Oct/2020 is
not equal to the
Date of Visit
20/Oct/2020
within same
unplanned visit.
Please review
and update as
appropriate.
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493631
Page 215 of 251
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled
Visit on Oct/20/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Oct-23-2020
11:38:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Contact:
Oct/21/2020
Contact Outcome:
VISIT NOT REQUIRE
D, INVESTIGATOR D
ECISIONInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493632
Page 216 of 251
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Apr-09-2021
14:39:55
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Apr/9/2021Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493633
Page 217 of 251
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Apr-09-2021
14:40:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obt
ained
Apr/9/2021Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493634
Page 218 of 251
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Apr-09-2021
14:40:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Apr-09-2021
14:40:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Apr-09-2021
14:56:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Apr-09-2021
14:40:23ACV0PF
EINFP60auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493635
Page 219 of 251
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00  Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Apr-09-2021
14:40:23
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Apr/9/2021Initial Entry
5.a
Date Location User Value Reason
Apr-09-2021
14:56:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRTSPBInitial Entry
5.a Sample ID
Date Location User Value Reason
Apr-09-2021
14:56:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BRTSPBInitial Entry
5.b
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493636
Page 220 of 251
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Apr-09-2021
14:56:21
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR9DNKInitial Entry
5.b Sample ID
Date Location User Value Reason
Apr-09-2021
14:56:21
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BR9DNKInitial Entry
5.c
Date Location User Value Reason
Apr-09-2021
14:56:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR9DNLInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493637
Page 221 of 251
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Sample ID
Date Location User Value Reason
Apr-09-2021
14:56:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BR9DNLInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493638
Page 222 of 251
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Apr-09-2021
14:40:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Apr-09-2021
14:40:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Apr-09-2021
14:56:55
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Apr-09-2021
14:40:35ACV0PF
EINFP60auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493639
Page 223 of 251
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00  Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Apr-09-2021
14:40:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Apr/9/2021Initial Entry
5.a
Date Location User Value Reason
Apr-09-2021
14:56:55
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR9DTRInitial Entry
5.a Sample ID
Date Location User Value Reason
Apr-09-2021
14:56:55
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BR9DTRInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493640
Page 224 of 251
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-29-2021
14:51:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-29-2021 14:51:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Jan-29-2021
14:51:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493641
Page 225 of 251
***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: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
May-14-2021
08:43:25
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
May/13/2021Initial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493642
Page 226 of 251
***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, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
May-14-2021
08:43:38
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Participant is NOT willing t
o return for Vaccination 3 O
R otherwise not eligibleInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493643
Page 227 of 251
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Date Location User Value Reason
Nov-11-2020
11:52:36
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493644
Page 228 of 251
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-11-2020
11:52:36
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-11-2020
11:52:36
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-25-2020
22:52:38
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Nov-25-2020
09:00:08ACV0PF
EINFP60auto query
(autoquery)Query 1: Answered Changed
Information
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2022-5812-0493645
Page 229 of 251
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time
(US & Canada)00 
Nov-25-2020
09:00:08
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PF
EINFP60
00 Data Entry:
worsening right ankle
painChanged
Information
Nov-25-2020
07:53:07
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PF
EINFP60
00.InFor
mAdapte
r.Discrep
ancy PFE SDQ PROD Query 1: Opened The AE right
ankle pain was
reported but is
also listed in
Medical
History. Please
clarify if this is
a worsening of
the baseline
condition, and if
so, please
consider adding
"worsening" to
the AE term.
AE as baseline
conditions
should only be
reported as AEs
if they worsen.
Nov-11-2020
11:52:36ACV0PF
EINFP60Data Entry:
right ankle painInitial Entry
090177e19891a03e\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493646
Page 230 of 251
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091221 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time
(US & Canada)00 
4. Start Date Time:
Date Location User Value Reason
Nov-11-2020
11:52:36
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Oct/19/2020 17:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-11-2020
11:53:49
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-11-2020
11:53:49
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NO
End Date Time:
Oct/19/2020 UNK:UNKTranscription
Error
Nov-11-2020
11:52:36
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened For right ankle
pain En
…[truncated]