Document text
Page 1 of 456
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version01 DEC 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494113
Page 2 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/4/2021
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494114
Page 3 of 456
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [10091382]
2.Birth Date: 2006
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2022-5812-0494115
Page 4 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494116
Page 5 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494117
Page 6 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathJan/4/2021
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494118
Page 7 of 456
***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: 10091382 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:[ANXIETY]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[CELIAC DISEASE]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494119
Page 8 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494120
Page 9 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/4/2021
2.Weight: [156.2]
3.Unit: LB
4.Height: [63.0]
5.Unit: in
6.Body Mass Index: [27.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494121
Page 10 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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: Jan/4/2021
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:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494122
Page 11 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Jan/4/2021
2.Randomization Number: [24808]
3.Randomization Group: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494123
Page 12 of 456
***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: 10091382 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/4/2021
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 [BR5BNH]
5.bSample ID [BSJ3R2]
5.cSample ID [BR5BNG]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494124
Page 13 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/4/2021
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 [BGH063]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494125
Page 14 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Jan/4/2021 16:30
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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494126
Page 15 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494127
Page 16 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494128
Page 17 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494129
Page 18 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494130
Page 19 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494131
Page 20 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/25/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494132
Page 21 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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: Jan/25/2021
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:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494133
Page 22 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/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 [BR9FBK]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494134
Page 23 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Jan/25/2021 16:17
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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494135
Page 24 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494136
Page 25 of 456
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494137
Page 26 of 456
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494138
Page 27 of 456
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494139
Page 28 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR622B]
5.bSample ID [BR6229]
5.cSample ID [BSJ4CV]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494140
Page 29 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/19/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494141
Page 30 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: May/19/2021
2.Date of First Symptom
Started:May/15/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
May/20/2021
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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494142
Page 31 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete, Not Complete
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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: [ ]
5.bSymptoms - Other Text: [ ]
5.cSymptoms - Other Text: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494143
Page 32 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494144
Page 33 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494145
Page 34 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
May/19/2021
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 [RR11673]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494146
Page 35 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[self swab collected] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494147
Page 36 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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:YES
Number of Visits or Contacts:
[1]
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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494148
Page 37 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494149
Page 38 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494150
Page 39 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: 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: 10091382 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?
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494151
Page 40 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: 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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494152
Page 41 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494153
Page 42 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: 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: 10091382 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:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494154
Page 43 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494155
Page 44 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494156
Page 45 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494157
Page 46 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494158
Page 47 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494159
Page 48 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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:[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494160
Page 49 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494161
Page 50 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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 % [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494162
Page 51 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494163
Page 52 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: 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: 10091382 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):[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494164
Page 53 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494165
Page 54 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: 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: 10091382 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?
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494166
Page 55 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494167
Page 56 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: 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: 10091382 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:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494168
Page 57 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/2/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494169
Page 58 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jul/2/2021
2.Date of First Symptom
Started:Jun/29/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jul/3/2021
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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494170
Page 59 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 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: [rhinorrhea]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494171
Page 60 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494172
Page 61 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494173
Page 62 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
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: 10091382 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/8/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[date of collection is more than 4 days after symptom
resolution, PD captured]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RR23599]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494174
Page 63 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 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 [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494175
Page 64 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494176
Page 65 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494177
Page 66 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494178
Page 67 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 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?
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494179
Page 68 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494180
Page 69 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494181
Page 70 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 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:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494182
Page 71 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494183
Page 72 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494184
Page 73 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494185
Page 74 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494186
Page 75 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494187
Page 76 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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:[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494188
Page 77 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494189
Page 78 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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 % [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494190
Page 79 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494191
Page 80 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 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):[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494192
Page 81 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494193
Page 82 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 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?
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494194
Page 83 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494195
Page 84 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 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:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494196
Page 85 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494197
Page 86 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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 [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494198
Page 87 of 456
***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: 10091382 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:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494199
Page 88 of 456
***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: 10091382 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 [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494200
Page 89 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494201
Page 90 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Unplanned Assessments
1.Assessments
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494202
Page 91 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494203
Page 92 of 456
***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: 10091382 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:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494204
Page 93 of 456
***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: 10091382 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:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494205
Page 94 of 456
***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: 10091382 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?
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494206
Page 95 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494207
Page 96 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494208
Page 97 of 456
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/7/2021
2.Erroneous Visit
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494209
Page 98 of 456
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Apr/7/2021
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494210
Page 99 of 456
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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/7/2021
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 [BR9DND]
5.bSample ID [BR9DNF]
5.cSample ID [BRTSP7]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494211
Page 100 of 456
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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/7/2021
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 [BR9DTK]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494212
Page 101 of 456
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Feb/25/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494213
Page 102 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/13/2021
2.Erroneous Visit
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494214
Page 103 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494215
Page 104 of 456
***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: 10091382 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: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494216
Page 105 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# CategoryAE Id
entifie
rAdverse E
ventStart DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
1. ADVER
SE EVE
NT 1 RIGHT K
NEE PAIN
Jan/10/2021
UNK:UNK NO
End Date Time:
Jan/25/2021 U
NK:UNK
Repeating
Pages
2. ADVER
SE EVE
NT 2 chills Jun/3/2021
UNK:UNK NO
End Date Time:
Jun/3/2021 UN
K:UNK
Repeating
Pages
3. ADVER
SE EVE
NT 3 generalized
muscle pai
n May/15/202
1 UNK:UN
K NO
End Date Time:
May/20/2021
UNK:UNK
Repeating
Pages
4. DELETED ADVER
SE EVE
NT 4 Sore Throa
t May/15/202
1 UNK:UN
K NO
End Date Time:
May/20/2021
UNK:UNK
Repeating
Pages
5. ADVER
SE EVE
NT 5 dizziness May/15/202
1 UNK:UN
K NO
End Date Time:Repeating
Pages
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494217
Page 106 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# CategoryAE Id
entifie
rAdverse E
ventStart DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
May/16/2021
UNK:UNK
6. ADVER
SE EVE
NT 6 rhinorrhea May/15/202
1 UNK:UN
K NO
End Date Time:
May/17/2021
UNK:UNK
Repeating
Pages
7. ADVER
SE EVE
NT 7 nausea May/15/202
1 UNK:UN
K NO
End Date Time:
May/17/2021
UNK:UNK
Repeating
Pages
8. DELETED ADVER
SE EVE
NT 8 headache Jan/6/2021
14:00 NO
End Date Time:
Jan/6/2021 17:
01
Repeating
Pages
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494218
Page 107 of 456
***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: 10091382 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)[RIGHT KNEE PAIN]
4.Start Date Time: Jan/10/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/25/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494219
Page 108 of 456
***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: 10091382 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:
[DANCING OVERUSE]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494220
Page 109 of 456
***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: 10091382 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[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494221
Page 110 of 456
***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: 10091382 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)[chills]
4.Start Date Time: Jun/3/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/3/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494222
Page 111 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494223
Page 112 of 456
***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: 10091382 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[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494224
Page 113 of 456
***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: 10091382 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: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[generalized muscle pain]
4.Start Date Time: May/15/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
May/20/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494225
Page 114 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494226
Page 115 of 456
***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: 10091382 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[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494227
Page 116 of 456
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Sore Throat ]
4.Start Date Time: May/15/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
May/20/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494228
Page 117 of 456
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494229
Page 118 of 456
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494230
Page 119 of 456
***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: 10091382 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: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[dizziness]
4.Start Date Time: May/15/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
May/16/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494231
Page 120 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494232
Page 121 of 456
***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: 10091382 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[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494233
Page 122 of 456
***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: 10091382 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: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[rhinorrhea]
4.Start Date Time: May/15/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
May/17/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494234
Page 123 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494235
Page 124 of 456
***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: 10091382 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[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494236
Page 125 of 456
***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: 10091382 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: [7]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[nausea]
4.Start Date Time: May/15/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
May/17/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494237
Page 126 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494238
Page 127 of 456
***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: 10091382 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[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494239
Page 128 of 456
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[headache]
4.Start Date Time: Jan/6/2021 14:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/6/2021 17:01
6.Toxicity Grade: 1
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494240
Page 129 of 456
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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?YES
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494241
Page 130 of 456
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494242
Page 131 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494243
Page 132 of 456
***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: 10091382 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[ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494244
Page 133 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494245
Page 134 of 456
***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: 10091382 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: //
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494246
Page 135 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494247
Page 136 of 456
***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: 10091382 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?
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494248
Page 137 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494249
Page 138 of 456
***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: 10091382 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?
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494250
Page 139 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494251
Page 140 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494252
Page 141 of 456
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Apr/17/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/17/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494253
Page 142 of 456
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Apr/17/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Apr/17/2021
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 [AA45711]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494254
Page 143 of 456
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Apr/28/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/28/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494255
Page 144 of 456
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Apr/28/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Apr/28/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA45779]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494256
Page 145 of 456
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on May/12/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/12/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK6
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494257
Page 146 of 456
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on May/12/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
May/12/2021
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 [AA45780]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494258
Page 147 of 456
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : May/13/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494259
Page 148 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494260
Page 149 of 456
***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: 10091382 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: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494261
Page 150 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/14/2021
2.Erroneous Visit
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494262
Page 151 of 456
***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: 10091382 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
May/14/2021
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494263
Page 152 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494264
Page 153 of 456
***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: 10091382 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 :May/14/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494265
Page 154 of 456
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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: May/14/2021
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:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494266
Page 155 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
May/14/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRTSSS]
5.bSample ID [BTLHCB]
5.cSample ID [BTLHC9]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494267
Page 156 of 456
***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: 10091382 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:
May/14/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BTLH7P]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494268
Page 157 of 456
***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: 10091382 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: May/14/2021 09:08
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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494269
Page 158 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/2/2021
2.Erroneous Visit
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494270
Page 159 of 456
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Apr-2021 01:41 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 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: Jun/2/2021
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:
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494271
Page 160 of 456
***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: 10091382 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:
Jun/2/2021
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 [BTLH8Y]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494272
Page 161 of 456
***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: 10091382 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: Jun/2/2021 09:54
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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494273
Page 162 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/2/2021
2.Erroneous Visit
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494274
Page 163 of 456
***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: 10091382 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:
Jul/2/2021
3.Comments: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494275
Page 164 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494276
Page 165 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494277
Page 166 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494278
Page 167 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494279
Page 168 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Jul/2/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494280
Page 169 of 456
***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: 10091382 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 Feb/25/2021
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494281
Page 170 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494282
Page 171 of 456
***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: 10091382 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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494283
Page 172 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-04-2021 16:49:21 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494284
Page 173 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMay-21-2021 10:52:11 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494285
Page 174 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1May-21-2021 10:52:11 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494286
Page 175 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2May-21-2021 10:52:11 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494287
Page 176 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3May-21-2021 10:52:11 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494288
Page 177 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4May-21-2021 10:52:11 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494289
Page 178 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5May-21-2021 10:52:11 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494290
Page 179 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6May-21-2021 10:52:11 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494291
Page 180 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
7May-21-2021 10:52:11 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494292
Page 181 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
8May-21-2021 10:52:11 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494293
Page 182 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
9May-21-2021 10:52:11 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494294
Page 183 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on May/19/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMay-21-2021 10:52:50 (UTC-07:00)
Mountain Time (US & Canada)
FormMay-20-2021 09:56:23 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494295
Page 184 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1May-21-2021 10:52:50 (UTC-07:00)
Mountain Time (US & Canada)
1May-20-2021 09:56:23 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494296
Page 185 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2May-21-2021 10:52:50 (UTC-07:00)
Mountain Time (US & Canada)
2May-20-2021 09:56:23 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494297
Page 186 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3May-21-2021 10:52:50 (UTC-07:00)
Mountain Time (US & Canada)
3May-20-2021 09:56:23 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494298
Page 187 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - Comments
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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4May-21-2021 10:52:50 (UTC-07:00)
Mountain Time (US & Canada)
4May-20-2021 09:56:23 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494299
Page 188 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJul-06-2021 08:16:55 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494300
Page 189 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jul-06-2021 08:16:55 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494301
Page 190 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jul-06-2021 08:16:55 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494302
Page 191 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jul-06-2021 08:16:55 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494303
Page 192 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jul-06-2021 08:16:55 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494304
Page 193 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jul-06-2021 08:16:55 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494305
Page 194 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6Jul-06-2021 08:16:55 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494306
Page 195 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
7Jul-06-2021 08:16:55 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494307
Page 196 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
8Jul-06-2021 08:16:55 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494308
Page 197 of 456
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 -
Unscheduled Visit on Jul/02/2021Form: 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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
9Jul-06-2021 08:16:55 (UTC-07:00)
Mountain Time (US & Canada)Not Done
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494309
Page 198 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMay-14-2021 10:23:08 (UTC-07:00)
Mountain Time (US & Canada)Not Applicable
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494310
Page 199 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
N/A Apr-20-2021 09:42:22 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Apr-13-2021 18:55:07 (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-07-2021 17:17:29 (UTC-07:00)
Mountain Time (US & Canada)Edit - All
signatures
invalidated
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0494311
Page 200 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
N/A
Approved Mar-11-2021 21:49:21 (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.
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0494312
Page 201 of 456
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jan-04-2021
16:48:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
01 DEC 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jan-04-2021
16:48:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494313
Page 202 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-04-2021
16:48:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obt
ained
Jan/4/2021Initial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494314
Page 203 of 456
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject ID
Date Location User Value Reason
Jan-04-2021 16:48:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
10091382Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Jan-04-2021 16:48:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2006Enrollment Entry
3. Sex:
Date Location User Value Reason
Jan-04-2021
16:49:04
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jan-04-2021 ACV0PF Data Entry: Initial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (6)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494315
Page 204 of 456
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
16:49:04
(UTC-07:00)
Mountain Time (US
& Canada)EINFP60
00 HISPANIC OR LATINO(A
) OR OF SPANISH ORIGI
N
5. Race: (Check X all that apply):
Date Location User Value Reason
Jan-04-2021
16:49:04
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
WHITEInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494316
Page 205 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-04-2021
16:49:14
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/4/2021Initial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494317
Page 206 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jan-04-2021
16:49:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/4/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-04-2021 16:49:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jan-04-2021
16:49:33
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494318
Page 207 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.a
Date Location User Value Reason
Jan-04-2021 16:51:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical Histor
y Term:ANXIETY
Start Date: UNK/UNK
/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jan-04-2021 16:51:13
(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
Jan-04-2021
16:51:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
ANXIETYInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494319
Page 208 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.a Start Date:
Date Location User Value Reason
Jan-04-2021
16:51:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jan-04-2021
16:51:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jan-04-2021 16:55:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:CELIAC DI
SEASE
Start Date: UNK/UNK/
2013
Ongoing: YESInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494320
Page 209 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.b Line/MH Number:
Date Location User Value Reason
Jan-04-2021 16:55:16
(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
Jan-05-2021
13:22:41
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: Closed Response satisfies
query
Jan-05-2021
11:09:19
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: Answered they have not
received
exclusionary
medication
Jan-05-2021
10:25:52
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PF
EINFP60
00 Query 1: Opened GPD Clin: Please
confirm if
participant has/has
not received
systemic
corticosteroids or
immunosuppressants
(eg. azathioprine)
for refractory Celiac
Disease.
090177e19891a03f\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-2022-5812-0494321
Page 210 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-04-2021
16:55:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PF
EINFP60
00 Data Entry:
CELIAC DISEASEInitial Entry
1.b Start Date:
Date Location User Value Reason
Jan-04-2021
16:55:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2013Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jan-04-2021
16:55:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03f\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-2022-5812-0494322
Page 211 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Jan-04-2021
16:55:22
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
The subject is NOT known
to be HIV POSITIVEInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494323
Page 212 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-04-2021
16:55:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/4/2021Initial Entry
2. Weight:
Date Location User Value Reason
Jan-04-2021
16:55:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
156.2Initial Entry
3. Unit:
Date Location User Value Reason
Jan-04-2021
16:55:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
LBInitial Entry
4. Height:
090177e19891a03f\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-2022-5812-0494324
Page 213 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-04-2021
16:55:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
63.0Initial Entry
5. Unit:
Date Location User Value Reason
Jan-04-2021
16:55:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jan-04-2021 16:55:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
27.7Initial Entry
7.a
Date Location User Value Reason
Jan-04-2021
16:55:48
(UTC-07:00)
Mountain Time (USACV0PF
EINFP60
00 Data Entry:
Record Identif
ier::1Initial Entry
090177e19891a03f\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-2022-5812-0494325
Page 214 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada) Temperature: 98.1
Temperature
Unit:F
Temperature
Location::ORAL CA
VITY
7.a Record Identifier:
Date Location User Value Reason
Jan-04-2021
16:55:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jan-04-2021
16:55:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Jan-04-2021
16:55:48
(UTC-07:00)
Mountain Time (USACV0PF
EINFP60
00 Data Entry:
FInitial Entry
090177e19891a03f\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-2022-5812-0494326
Page 215 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada)
7.a Temperature Location:
Date Location User Value Reason
Jan-04-2021
16:55:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494327
Page 216 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-04-2021 16:56:03
(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
Jan-04-2021 16:56:03
(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
Jan-04-2021
16:56:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/4/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494328
Page 217 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-04-2021 16:56:03
(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
Jan-04-2021 16:56:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-04-2021 16:56:03
(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:
Date Location User Value Reason
Jan-04-2021 16:56:03
(UTC-07:00)ACV0PF
EINFP60auto calc
(autocalc)Data Entry:
113Initial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494329
Page 218 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)00
6.a Test:
Date Location User Value Reason
Jan-04-2021
16:56:03
(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
Jan-04-2021
16:56:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NEGATIVEInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494330
Page 219 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jan-04-2021
16:56:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/4/2021Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jan-04-2021
16:56:16
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
24808Initial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494331
Page 220 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-04-2021 16:58:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-04-2021 16:58:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-04-2021
16:58:27
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-04-2021
16:58:18
(UTC-07:00)
Mountain Time (USACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494332
Page 221 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada) entered. Please
review and
correct as
appropriate.
Jan-04-2021
16:58:18
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/4/2021Initial Entry
5.a
Date Location User Value Reason
Jan-04-2021
16:58:27
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR5BNHInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-04-2021
16:58:27
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BR5BNHInitial Entry
5.b
Date Location User Value Reason
090177e19891a03f\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-2022-5812-0494333
Page 222 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-04-2021
16:58:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BSJ3R2Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-04-2021
16:58:57
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BSJ3R2Initial Entry
5.c
Date Location User Value Reason
Jan-04-2021
16:59:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR5BNGInitial Entry
090177e19891a03f\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-2022-5812-0494334
Page 223 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.c Sample ID
Date Location User Value Reason
Jan-04-2021
16:59:07
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BR5BNGInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494335
Page 224 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-04-2021 16:57:46
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-04-2021 16:57:46
(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
Jan-04-2021
16:57:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-04-2021
16:57:46
(UTC-07:00)
Mountain Time (USACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494336
Page 225 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada) entered. Please
review and
correct as
appropriate.
Jan-04-2021
16:57:46
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/4/2021Initial Entry
5.a
Date Location User Value Reason
Jan-04-2021
16:57:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BGH063Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-04-2021
16:57:54
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BGH063Initial Entry
090177e19891a03f\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-2022-5812-0494337
Page 226 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-04-2021
16:56:39
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-04-2021 16:56:39
(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
Jan-04-2021 16:56:39
(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
Jan-04-2021 ACV0PF Data Entry: Initial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494338
Page 227 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
16:56:39
(UTC-07:00)
Mountain Time (US
& Canada)EINFP60
00 Jan/4/2021 16:30
5. Anatomical Location:
Date Location User Value Reason
Jan-04-2021 16:56:39
(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
Jan-25-2021
17:34:47
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTTranscription
Error
Jan-04-2021
16:56:39
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Jan-04-2021 16:56:39
(UTC-07:00)ACV0PF
EINFP60auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e19891a03f\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-2022-5812-0494339
Page 228 of 456
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)00
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-04-2021 16:56:39
(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
Jan-04-2021
16:56:39
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494340
Page 229 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Jan-04-2021
16:56:48
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES - REACTOGENICIT
Y E-DIARY COLLECTED
FOR THIS SUBJECTInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0494341
Page 230 of 456
***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: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-25-2021
17:05:30
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/25/2021Initial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494342
Page 231 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
090177e19891a03f\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-2022-5812-0494343
Page 232 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-25-2021
17:05:59
(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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494344
Page 233 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e19891a03f\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-2022-5812-0494345
Page 234 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NO
2.c Symptom:
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HIInitial Entry
090177e19891a03f\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-2022-5812-0494346
Page 235 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)LL
S
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
O
2.d Symptom:
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-25-2021
17:05:59ACV0PF
EINFP60Data Entry:
Symptom:: VOInitial Entry
090177e19891a03f\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-2022-5812-0494347
Page 236 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-07:00)
Mountain Time (US
& Canada)00 MI
TIN
G
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NO
2.e Symptom:
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
090177e19891a03f\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-2022-5812-0494348
Page 237 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
090177e19891a03f\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-2022-5812-0494349
Page 238 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Feb-01-2021
12:23:41
(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?:NOentered DCF to
change data.
Muscle pain
should be
entered as an
AE of knee pain
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:YES
Ongoing
?
YESInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b)
(4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494350
Page 239 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.g Symptom:
Date Location User Value Reason
Jan-25-2021
17:05:59
(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
Feb-02-2021
05:25:08
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Trial Max data
updated.
Feb-01-2021
12:23:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered entered DCF to
change data.
Muscle pain
should be
entered as an AE
of knee pain
Feb-01-2021
12:23:41
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOentered DCF to
change data.
Muscle pain
should be
entered as an AE
of knee pain
090177e19891a03f\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-2022-5812-0494351
Page 240 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-01-2021
07:18:53
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Reissued:Opened eDiary RQ: Per
Diary records,
MUSCLE PAIN
is not ongoing
on 25Jan21
which is Day 1
of VAX2. Please
reconcile and
update as stop
date. Else,
clarify in query
response.
Thanks.
Jan-29-2021
14:41:46
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered correct as is.
ongoing at visit
2
Jan-27-2021
05:16:49
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Opened eDiary: Per
Diary records,
'NEW OR
WORSENED
MUSCLE PAIN'
reported post
Vaccination 1 is
not ongoing
through
Vaccination 2.
Please reconcile
and consider to
update stop date
090177e19891a03f\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-2022-5812-0494352
Page 241 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
here. Else,
clarify in query
response.
Thanks.
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Ongoing?
YESInitial Entry
2.h
Date Location User Value Reason
Jan-25-2021
17:13:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:NOInitial Entry
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENEDInitial Entry
090177e19891a03f\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-2022-5812-0494353
Page 242 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
JOINT P
AIN
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:
2.h Symptom:
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
17:13:13
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494354
Page 243 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-25-2021 17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Jan-26-2021
06:35:52
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Jan-25-2021
17:13:27
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered correct as is
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Injection Site
Body Side
entered on this
page is not
matching with
Body Side
entered on
Vaccination page
of V1D1VX1L.
Please review
and update as
appropriate.
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494355
Page 244 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-25-2021
17:05:59
(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
090177e19891a03f\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-2022-5812-0494356
Page 245 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Jan-25-2021
17:05:59
(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
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494357
Page 246 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reac
tion::PAIN
AT INJ
ECTI
ON SI
TEInitial Entry
090177e19891a03f\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-2022-5812-0494358
Page 247 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-25-2021
17:05:59
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494359
Page 248 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-25-2021
17:06:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/25/2021Initial Entry
2.a
Date Location User Value Reason
Jan-25-2021
17:06:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identifi
er::1
Temperature: 97.1
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-25-2021
17:06:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
090177e19891a03f\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-2022-5812-0494360
Page 249 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.a Temperature:
Date Location User Value Reason
Jan-25-2021
17:06:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
97.1Initial Entry
2.a Unit:
Date Location User Value Reason
Jan-25-2021
17:06:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Jan-25-2021
17:06:50
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a03f\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-2022-5812-0494361
Page 250 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-25-2021 17:07:01
(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
Jan-25-2021 17:07:01
(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
Jan-25-2021
17:07:01
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/25/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494362
Page 251 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-25-2021 17:07:01
(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
Jan-25-2021 17:07:01
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-25-2021 17:07:01
(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:
Date Location User Value Reason
Jan-25-2021 17:07:01
(UTC-07:00)ACV0PF
EINFP60auto calc
(autocalc)Data Entry:
113Initial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494363
Page 252 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mountain Time (US
& Canada)00
6.a Test:
Date Location User Value Reason
Jan-25-2021
17:07:01
(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
Jan-25-2021
17:07:01
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
NEGATIVEInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0494364
Page 253 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-25-2021 17:09:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-25-2021 17:09:09
(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
Jan-25-2021
17:09:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-25-2021
17:09:09
(UTC-07:00)
Mountain Time (USACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0494365
Page 254 of 456
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1009 Site Name: (1009) J. Lewis Research, Inc. Foothill Family
Clinic South
Subject No: 10091382 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
& Canada) entered. Please
review and
correct as
appropriate.
Jan-25-2021
17:09:09
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/25/2021Initial Entry
5.a
Date Location User Value Reason
Jan-25-2021
17:09:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BR9FBKInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-25-2021
17:09:28
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
BR9FBKInitial Entry
090177e19891a03f\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-C
…[truncated]