125742 45 S211 M5 c4591001 1009 10091294

Document text

Page 1 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493669
Page 2 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/7/2020
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493670
Page 3 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [10091294]
2.Birth Date: 2005
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0493671
Page 4 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/7/2020
2.Erroneous Visit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493672
Page 5 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493673
Page 6 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathDec/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493674
Page 7 of 444
***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: 10091294 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:[dermatitis, atopic]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[acne, generalized]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[menorrhagia]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493675
Page 8 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493676
Page 9 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Dec/7/2020
2.Weight: [113.4]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [17.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493677
Page 10 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/7/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493678
Page 11 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Dec/7/2020
2.Randomization Number: [21177]
3.Randomization Group: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493679
Page 12 of 444
***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: 10091294 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/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 [BR9FWD]
5.bSample ID [BR9FWF]
5.cSample ID [BSJ3K5]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493680
Page 13 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/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 [BGH00K]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493681
Page 14 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Dec/7/2020 11:38
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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493682
Page 15 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493683
Page 16 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493684
Page 17 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493685
Page 18 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493686
Page 19 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493687
Page 20 of 444
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Dec/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493688
Page 21 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/28/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493689
Page 22 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/28/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BGH04D]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493690
Page 23 of 444
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Dec/28/2020 09:36
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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493691
Page 24 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493692
Page 25 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493693
Page 26 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493694
Page 27 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493695
Page 28 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR61SH]
5.bSample ID [BR61SJ]
5.cSample ID [BSJ3V3]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493696
Page 29 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/16/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493697
Page 30 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Mar/16/2021
2.Date of First Symptom
Started:Mar/14/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Mar/18/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493698
Page 31 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493699
Page 32 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493700
Page 33 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493701
Page 34 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
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: 10091294 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:
Mar/16/2021
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 [RR12143]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493702
Page 35 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: 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: 10091294 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? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493703
Page 36 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493704
Page 37 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
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?NO
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493705
Page 38 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493706
Page 39 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493707
Page 40 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493708
Page 41 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493709
Page 42 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493710
Page 43 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493711
Page 44 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493712
Page 45 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493713
Page 46 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493714
Page 47 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493715
Page 48 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493716
Page 49 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493717
Page 50 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493718
Page 51 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493719
Page 52 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: OXYGENATION PARAMETERS
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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493720
Page 53 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493721
Page 54 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 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.Start Date: //
6.Ongoing?
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493722
Page 55 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493723
Page 56 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493724
Page 57 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/25/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493725
Page 58 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jun/25/2021
2.Date of First Symptom
Started:Jun/22/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jul/1/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493726
Page 59 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493727
Page 60 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice T
ypeForm Instan
ce
 1.Not Applic
able Not Appli
cable Not Applicable  Not Applicable  Not Appli
cable Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493728
Page 61 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection
Location:Not Applicable Comments
4.Assay Code and
Description:Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings
/Details:Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493729
Page 62 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
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: 10091294 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:
Jun/25/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RR26524]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493730
Page 63 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: 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: 10091294 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? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[NA]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493731
Page 64 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493732
Page 65 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
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?NO
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493733
Page 66 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatme
ntTreatme
ntStart Dat
eForm Instan
ce
 1.Not Applicab
le Not Applicable  Not Appli
cable Not Appli
cable Not Appli
cable Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493734
Page 67 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment
Identifier?Not Applicable
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493735
Page 68 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 2
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493736
Page 69 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493737
Page 70 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical
Event:Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493738
Page 71 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493739
Page 72 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493740
Page 73 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493741
Page 74 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493742
Page 75 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493743
Page 76 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493744
Page 77 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493745
Page 78 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493746
Page 79 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493747
Page 80 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: OXYGENATION PARAMETERS
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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493748
Page 81 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493749
Page 82 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 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.Start Date: //
6.Ongoing?
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493750
Page 83 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493751
Page 84 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493752
Page 85 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/27/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_C
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493753
Page 86 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jul/27/2021
2.Date of First Symptom
Started:Jul/23/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jul/24/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493754
Page 87 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [stomach ache]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493755
Page 88 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493756
Page 89 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493757
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
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: 10091294 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:
Jul/27/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RR23551]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493758
Page 91 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: 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: 10091294 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? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493759
Page 92 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493760
Page 93 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
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?NO
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493761
Page 94 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493762
Page 95 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493763
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493764
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493765
Page 98 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493766
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493767
Page 100 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493768
Page 101 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493769
Page 102 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493770
Page 103 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493771
Page 104 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493772
Page 105 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493773
Page 106 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493774
Page 107 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493775
Page 108 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: OXYGENATION PARAMETERS
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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493776
Page 109 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493777
Page 110 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 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.Start Date: //
6.Ongoing?
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493778
Page 111 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 3 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493779
Page 112 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493780
Page 113 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Apr/14/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/14/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493781
Page 114 of 444
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Apr/14/2021Form: 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: 10091294 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/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 [BR9DP8]
5.bSample ID [BR9DP9]
5.cSample ID [BSJ448]
5.dSample ID [BSJ449]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493782
Page 115 of 444
***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: 10091294 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:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493783
Page 116 of 444
***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: 10091294 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 [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493784
Page 117 of 444
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493785
Page 118 of 444
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Unplanned Assessments
1.Assessments
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493786
Page 119 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493787
Page 120 of 444
***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: 10091294 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:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493788
Page 121 of 444
***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: 10091294 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:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493789
Page 122 of 444
***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: 10091294 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?
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493790
Page 123 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493791
Page 124 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493792
Page 125 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Jan/25/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493793
Page 126 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/2/2021
2.Erroneous Visit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493794
Page 127 of 444
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493795
Page 128 of 444
***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: 10091294 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: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493796
Page 129 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#CategoryAE Ide
ntifierAdverse Ev
entStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  bilateral sho
ulder pain Dec/22/2020
UNK:UNK NO
End Date Time:
Dec/24/2020 UNK
:UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  body aches  Apr/6/2021 18
:00 NO
End Date Time:
Apr/7/2021 UNK:
UNK
 Repeating
Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493797
Page 130 of 444
***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: 10091294 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)[bilateral shoulder pain]
4.Start Date Time: Dec/22/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/24/2020 UNK:UNK
6.Toxicity Grade: 1
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493798
Page 131 of 444
***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: 10091294 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:
[lifting heavy object]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493799
Page 132 of 444
***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: 10091294 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?NO
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[ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493800
Page 133 of 444
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[body aches]
4.Start Date Time: Apr/6/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Apr/7/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493801
Page 134 of 444
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493802
Page 135 of 444
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12.Was a Non-Drug Treatment
given?NO
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[ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493803
Page 136 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493804
Page 137 of 444
***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: 10091294 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[ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493805
Page 138 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493806
Page 139 of 444
***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: 10091294 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: //
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493807
Page 140 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493808
Page 141 of 444
***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: 10091294 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?
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493809
Page 142 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493810
Page 143 of 444
***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: 10091294 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?
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493811
Page 144 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493812
Page 145 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493813
Page 146 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Apr/2/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493814
Page 147 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493815
Page 148 of 444
***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: 10091294 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: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493816
Page 149 of 444
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/6/2021
2.Erroneous Visit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493817
Page 150 of 444
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Apr/6/2021
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493818
Page 151 of 444
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 28-Mar-2021 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 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 Done
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493819
Page 152 of 444
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Apr/6/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493820
Page 153 of 444
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 28-Mar-2021 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Apr/6/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493821
Page 154 of 444
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 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/6/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9DN3]
5.bSample ID [BSJ43Z]
5.cSample ID [BRTSP1]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493822
Page 155 of 444
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 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/6/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9DT8]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493823
Page 156 of 444
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Apr/6/2021 09:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493824
Page 157 of 444
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493825
Page 158 of 444
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 28-Mar-2021 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Apr/28/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493826
Page 159 of 444
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 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/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 [BR9DRH]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493827
Page 160 of 444
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Apr/28/2021 09:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493828
Page 161 of 444
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/1/2021
2.Erroneous Visit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493829
Page 162 of 444
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 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:
Jun/1/2021
3.Comments: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493830
Page 163 of 444
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493831
Page 164 of 444
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493832
Page 165 of 444
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493833
Page 166 of 444
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493834
Page 167 of 444
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Jun/1/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493835
Page 168 of 444
***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: 10091294 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 Jan/25/2021
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493836
Page 169 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493837
Page 170 of 444
***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: 10091294 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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493838
Page 171 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormDec-07-2020 12:34:03 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493839
Page 172 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMar-16-2021 15:53:05 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493840
Page 173 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Mar-16-2021 15:53:05 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493841
Page 174 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Mar-16-2021 15:53:05 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493842
Page 175 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Mar-16-2021 15:53:05 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493843
Page 176 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Mar-16-2021 15:53:05 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493844
Page 177 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Mar-16-2021 15:53:05 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493845
Page 178 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Mar/16/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6Mar-16-2021 15:53:05 (UTC-07:00)
Mountain Time (US & Canada)Not Done
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Clinic South
Subject No: 10091294 Subject Initials: ---
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2Jun-28-2021 11:55:28 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
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(b) (4), 
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Clinic South
Subject No: 10091294 Subject Initials: ---
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ItemDate User Comment
3Jun-28-2021 11:55:28 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
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Clinic South
Subject No: 10091294 Subject Initials: ---
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ItemDate User Comment
4Jun-28-2021 11:55:28 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
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(b) (4), 
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Clinic South
Subject No: 10091294 Subject Initials: ---
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ItemDate User Comment
5Jun-28-2021 11:55:28 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
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(b) (4), 
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
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Back to Form
ItemDate User Comment
6Jun-28-2021 11:55:28 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
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Clinic South
Subject No: 10091294 Subject Initials: ---
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Back to Form
ItemDate User Comment
7Jun-28-2021 11:55:28 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
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(b) (4), 
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
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Back to Form
ItemDate User Comment
8Jun-28-2021 11:55:28 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
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(b) (4), 
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
9Jun-28-2021 11:55:28 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-28-2021 11:58:43 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jun-28-2021 11:58:43 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
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(b) (4), 
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-28-2021 11:58:43 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-28-2021 11:58:43 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
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(b) (4), 
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-28-2021 11:58:43 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jun-28-2021 11:58:43 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6Jun-28-2021 11:58:43 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJun-28-2021 11:59:33 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
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Mountain Time (US & Canada)Not Applicable
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jun-28-2021 11:59:33 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jun-28-2021 11:59:33 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
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Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jun/25/2021Form: ILLNESS DETAILS - SEVERE - Comments
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jun-28-2021 11:59:33 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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FormJul-28-2021 09:17:09 (UTC-07:00)
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Unscheduled Visit on Jul/27/2021Form: MICROBIOLOGY SPECIMEN - Comments
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jul-28-2021 09:17:09 (UTC-07:00)
Mountain Time (US & Canada)Not Done
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Page 206 of 444
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Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: MICROBIOLOGY SPECIMEN - Comments
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jul-28-2021 09:17:09 (UTC-07:00)
Mountain Time (US & Canada)Not Done
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Page 207 of 444
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Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: MICROBIOLOGY SPECIMEN - Comments
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jul-28-2021 09:17:09 (UTC-07:00)
Mountain Time (US & Canada)Not Done
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Page 208 of 444
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Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: MICROBIOLOGY SPECIMEN - Comments
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jul-28-2021 09:17:09 (UTC-07:00)
Mountain Time (US & Canada)Not Done
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FDA-CBER-2022-5812-0493876
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Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: MICROBIOLOGY SPECIMEN - Comments
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jul-28-2021 09:17:09 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
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FDA-CBER-2022-5812-0493877
Page 210 of 444
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Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: MICROBIOLOGY SPECIMEN - Comments
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Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6Jul-28-2021 09:17:09 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493878
Page 211 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
7Jul-28-2021 09:17:09 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493879
Page 212 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
8Jul-28-2021 09:17:09 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493880
Page 213 of 444
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 3 -
Unscheduled Visit on Jul/27/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
9Jul-28-2021 09:17:09 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493881
Page 214 of 444
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 28-Mar-2021 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormApr-06-2021 12:05:56 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0493882
Page 215 of 444
***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: 10091294 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-14-2021 09:45:18 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Apr-13-2021 18:30:54 (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-12-2021 14:48:36 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0493883
Page 216 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
N/A
 Approved Apr-06-2021 19:22:41 (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-06-2021 12:04:49 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-18-2021 18:59:59 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0493884
Page 217 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 Mar-18-2021 12:26:07 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-16-2021 18:16:34 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0493885
Page 218 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 Mar-16-2021 15:51:49 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-13-2021 16:59:33 (UTC-07:00)
Mountain Time (US & Canada)BOOK Signed
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0493886
Page 219 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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.
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0493887
Page 220 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Dec-07-2020
12:33:07
(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
Dec-07-2020
12:33:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493888
Page 221 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-07-2020
12:33:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obt
ained
Dec/7/2020Initial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493889
Page 222 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject ID
Date Location User Value Reason
Dec-07-2020
12:32:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
10091294Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Dec-07-2020
12:32:55
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2005Enrollment Entry
3. Sex:
Date Location User Value Reason
Dec-07-2020
12:33:25
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493890
Page 223 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Dec-07-2020
12:33:25
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
HISPANIC OR LATINO(A
) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Dec-07-2020
12:33:25
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
WHITEInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493891
Page 224 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-07-2020
12:33:40
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/7/2020Initial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493892
Page 225 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Dec-07-2020
12:34:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-07-2020
12:34:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Dec-07-2020
12:34:19
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493893
Page 226 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.a
Date Location User Value Reason
Dec-07-2020
12:35:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical Histor
y Term:dermatitis,
atopic
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Dec-07-2020
12:35:52
(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
Dec-07-2020
12:35:52
(UTC-07:00)
Mountain Time (USACV0PF
EINFP60
00 Data Entry:
dermatitis, atopicInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493894
Page 227 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada)
1.a Start Date:
Date Location User Value Reason
Dec-07-2020
12:35:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Dec-07-2020
12:35:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Dec-07-2020
12:36:36
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:acne, gene
ralized
Start Date: UNK/UN
K/2017
Ongoing: YESTranscription
Error
090177e19891a03d\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-2022-5812-0493895
Page 228 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Dec-07-2020
12:36:06
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:acne
Start Date: UNK/UN
K/2017
Ongoing: YESInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493896
Page 229 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.b Line/MH Number:
Date Location User Value Reason
Dec-07-2020
12:36:06
(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
Dec-07-2020
12:36:36
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
acne, generalizedTranscription
Error
Dec-07-2020
12:36:06
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
acneInitial Entry
1.b Start Date:
Date Location User Value Reason
Dec-07-2020
12:36:06
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2017Initial Entry
090177e19891a03d\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-2022-5812-0493897
Page 230 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.b Ongoing:
Date Location User Value Reason
Dec-07-2020
12:36:06
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Dec-28-2020
16:35:10
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical Histor
y Term:menorrhagi
a
Start Date: UNK/UNK
/2018
Ongoing: YESInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493898
Page 231 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.c Line/MH Number:
Date Location User Value Reason
Dec-28-2020
16:35:10
(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
Dec-28-2020
16:35:10
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
menorrhagiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Dec-28-2020
16:35:10
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493899
Page 232 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Dec-28-2020
16:35:10
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493900
Page 233 of 444
***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: 10091294 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
Dec-07-2020
12:37:12
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
The subject is NOT known
to be HIV POSITIVEInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493901
Page 234 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Dec-07-2020
12:37:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Dec-07-2020
12:37:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
113.4Initial Entry
3. Unit:
Date Location User Value Reason
Dec-07-2020
12:37:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
LBInitial Entry
4. Height:
090177e19891a03d\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-2022-5812-0493902
Page 235 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Dec-07-2020
12:37:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Dec-07-2020
12:37:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Dec-07-2020
12:37:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
17.8Initial Entry
7.a
Date Location User Value Reason
Dec-07-2020
12:37:47
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
Record Identif 1Initial Entry
090177e19891a03d\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-2022-5812-0493903
Page 236 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)ier::
Temperature: 99.0
Temperature
Unit:F
Temperature
Location::ORAL CA
VITY
7.a Record Identifier:
Date Location User Value Reason
Dec-07-2020
12:37:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Dec-07-2020
12:37:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
99.0Initial Entry
7.a Unit:
Date Location User Value Reason
Dec-07-2020
12:37:47
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
090177e19891a03d\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-2022-5812-0493904
Page 237 of 444
***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: 10091294 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
Dec-07-2020
12:37:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493905
Page 238 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-07-2020
12:38:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-07-2020
12:38:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-07-2020
12:38:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/7/2020Initial Entry
4. Laboratory Name and Address (Derived)
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493906
Page 239 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Dec-07-2020
12:38:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-07-2020
12:38:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Dec-07-2020
12:38:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493907
Page 240 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Dec-07-2020
12:38:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-07-2020
12:38:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Result:
Date Location User Value Reason
Dec-07-2020
12:38:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NEGATIVEInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493908
Page 241 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Dec-07-2020
12:38:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Dec-07-2020
12:38:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
21177Initial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493909
Page 242 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-07-2020
12:42:31
(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
Dec-07-2020
12:42:31
(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
Dec-07-2020
12:42:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-07-2020
12:42:31ACV0PF
EINFP60auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493910
Page 243 of 444
***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: 10091294 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.
Dec-07-2020
12:42:31
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Dec/7/2020Initial Entry
5.a
Date Location User Value Reason
Dec-07-2020
12:42:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR9FWDInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-07-2020
12:42:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BR9FWDInitial Entry
5.b
090177e19891a03d\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-2022-5812-0493911
Page 244 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Dec-07-2020
12:42:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR9FWFInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-07-2020
12:42:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BR9FWFInitial Entry
5.c
Date Location User Value Reason
Dec-07-2020
12:43:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BSJ3K5Initial Entry
090177e19891a03d\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-2022-5812-0493912
Page 245 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Sample ID
Date Location User Value Reason
Dec-07-2020
12:43:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BSJ3K5Initial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493913
Page 246 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-07-2020
12:41:57
(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
Dec-07-2020
12:41:57
(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
Dec-07-2020
12:42:06
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-07-2020
12:41:57ACV0PF
EINFP60auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0493914
Page 247 of 444
***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: 10091294 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.
Dec-07-2020
12:41:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Dec/7/2020Initial Entry
5.a
Date Location User Value Reason
Dec-07-2020
12:42:06
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BGH00KInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-07-2020
12:42:06
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BGH00KInitial Entry
090177e19891a03d\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-2022-5812-0493915
Page 248 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-07-2020
12:39:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-07-2020
12:39:03
(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
Dec-07-2020
12:39:03
(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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493916
Page 249 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Dec-07-2020
12:39:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/7/2020 11:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-07-2020
12:39:03
(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
Dec-07-2020
12:39:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-07-2020
12:39:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493917
Page 250 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-07-2020
12:39:03
(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
Dec-07-2020
12:39:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493918
Page 251 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Dec-07-2020
12:39:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES - REACTOGENICIT
Y E-DIARY COLLECTED
FOR THIS SUBJECTInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0493919
Page 252 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-28-2020
13:03:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/28/2020Initial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493920
Page 253 of 444
***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: 10091294 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
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-28-2020
13:04:28
(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
Dec-28-2020
13:04:28
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
090177e19891a03d\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-2022-5812-0493921
Page 254 of 444
***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: 10091294 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
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-28-2020
13:04:28
(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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493922
Page 255 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Dec-28-2020
13:04:28
(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
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e19891a03d\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-2022-5812-0493923
Page 256 of 444
***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: 10091294 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
Dec-28-2020
13:04:28
(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
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-28-2020
13:04:28
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HIInitial Entry
090177e19891a03d\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-2022-5812-0493924
Page 257 of 444
***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: 10091294 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
Dec-28-2020
13:04:28
(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
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Dec-28-2020
13:04:28ACV0PF
EINFP60Data Entry:
Symptom:: VOInitial Entry
090177e19891a03d\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-2022-5812-0493925
Page 258 of 444
***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: 10091294 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
Dec-28-2020
13:04:28
(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
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e19891a03d\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-2022-5812-0493926
Page 259 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Dec-28-2020
13:04:28
(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
Dec-28-2020
13:04:28
(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
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
090177e19891a03d\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-2022-5812-0493927
Page 260 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Dec-28-2020
13:04:28
(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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493928
Page 261 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.g Symptom:
Date Location User Value Reason
Dec-28-2020
13:04:28
(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
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AINInitial Entry
090177e19891a03d\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-2022-5812-0493929
Page 262 of 444
***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: 10091294 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
Dec-28-2020
13:04:28
(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
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-28-2020
13:04:28ACV0PF
EINFP60auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493930
Page 263 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00 
4. Injection Site Body Side:
Date Location User Value Reason
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Dec-28-2020
13:04:28
(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
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493931
Page 264 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Dec-28-2020
13:04:28
(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
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-28-2020
13:04:28
(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
090177e19891a03d\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-2022-5812-0493932
Page 265 of 444
***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: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-28-2020
13:04:28
(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
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reac
tion::PAIN
AT INJ
ECTI
ON SI
TEInitial Entry
090177e19891a03d\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-2022-5812-0493933
Page 266 of 444
***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: 10091294 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
Dec-28-2020
13:04:28
(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
Dec-28-2020
13:04:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a03d\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2022-5812-0493934
Page 267 of 444
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091294 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Dec-28-2020
13:04:49
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/28/2020Initial Entry
2.a
Date Location User Value Reason

…[truncated]