Document text
Page 1 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496501
Page 2 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/15/2020
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496502
Page 3 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [11501210]
2.Birth Date: 2008
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0496503
Page 4 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496504
Page 5 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496505
Page 6 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathDec/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496506
Page 7 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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:[Seasonal Allergies]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Premenarchal]
Start Date: Nov/UNK/2020
Ongoing: YES
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496507
Page 8 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496508
Page 9 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Dec/15/2020
2.Weight: [86.1]
3.Unit: LB
4.Height: [59.0]
5.Unit: in
6.Body Mass Index: [17.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496509
Page 10 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/15/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496510
Page 11 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Dec/15/2020
2.Randomization Number: [22400]
3.Randomization Group: [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496511
Page 12 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/15/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRD38V]
5.bSample ID [BRD38W]
5.cSample ID [BLB0RX]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496512
Page 13 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/15/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRD38T]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496513
Page 14 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Dec/15/2020 15:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496514
Page 15 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496515
Page 16 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496516
Page 17 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496517
Page 18 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
3.Injection Site Location: DELTOID MUSCLE
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496518
Page 19 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496519
Page 20 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/7/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496520
Page 21 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/7/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496521
Page 22 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/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 [BPTYBJ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496522
Page 23 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/7/2021 11:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496523
Page 24 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496524
Page 25 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496525
Page 26 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
3.Injection Site Location: DELTOID MUSCLE
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496526
Page 27 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496527
Page 28 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/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 [BRF9S1]
5.bSample ID [BRF9S2]
5.cSample ID [BPMDLN]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496528
Page 29 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/21/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496529
Page 30 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jul/21/2021
2.Date of First Symptom
Started:Jul/15/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jul/21/2021
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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496530
Page 31 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Nasal Congestion]
5.bSymptoms - Other Text: [Runny nose]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496531
Page 32 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice T
ypeForm Instan
ce
1.Not Applic
able Not Appli
cable Not Applicable Not Applicable Not Appli
cable Repeating
Pages
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496532
Page 33 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection
Location:Not Applicable Comments
4.Assay Code and
Description:Not Applicable Comments
5.Device Type: Not Applicable Comments
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings
/Details:Not Applicable
[ ]Comments
9.Trade Name Other, Specify: Not Applicable
[ ]Comments
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496533
Page 34 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/21/2021
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 [RR27093]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496534
Page 35 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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 only]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496535
Page 36 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496536
Page 37 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496537
Page 38 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496538
Page 39 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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?
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496539
Page 40 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496540
Page 41 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496541
Page 42 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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:
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496542
Page 43 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496543
Page 44 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 10-Dec-2020 02:24 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496544
Page 45 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496545
Page 46 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 10-Dec-2020 02:28 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496546
Page 47 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496547
Page 48 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: VITAL SIGNS - COVID
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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:[ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496548
Page 49 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496549
Page 50 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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 % [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496550
Page 51 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496551
Page 52 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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):[ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496552
Page 53 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496553
Page 54 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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?
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496554
Page 55 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496555
Page 56 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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:
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496556
Page 57 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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:
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496557
Page 58 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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 [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496558
Page 59 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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:
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496559
Page 60 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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 [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496560
Page 61 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496561
Page 62 of 337
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Unplanned Assessments
1.Assessments
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496562
Page 63 of 337
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496563
Page 64 of 337
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 30-Apr-2021 01:41 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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:
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496564
Page 65 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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:
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496565
Page 66 of 337
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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?
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496566
Page 67 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496567
Page 68 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496568
Page 69 of 337
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496569
Page 70 of 337
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
Feb/4/2021
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496570
Page 71 of 337
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[sample collected for visit 3 blood samples, combined visits]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496571
Page 72 of 337
***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, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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:
Feb/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 [BRF9S0]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496572
Page 73 of 337
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/18/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK2
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496573
Page 74 of 337
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/18/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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:
Feb/18/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA10471]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496574
Page 75 of 337
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/05/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK4
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496575
Page 76 of 337
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Mar/05/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Mar/5/2021
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 [AA09971]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496576
Page 77 of 337
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/21/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/21/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK6
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496577
Page 78 of 337
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/21/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Mar/21/2021
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 [AA04972]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496578
Page 79 of 337
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 4 -
Unscheduled Visit on Apr/05/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/5/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK8
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496579
Page 80 of 337
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 4 -
Unscheduled Visit on Apr/05/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/5/2021
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 [AA05556]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496580
Page 81 of 337
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 5 -
Unscheduled Visit on Apr/19/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Apr/19/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK10
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496581
Page 82 of 337
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 5 -
Unscheduled Visit on Apr/19/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/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 [BTZY7V]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496582
Page 83 of 337
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 6 -
Unscheduled Visit on May/04/2021Form: DATE OF VISIT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/4/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance
Visit:SSWAB_WEEK12
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496583
Page 84 of 337
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 6 -
Unscheduled Visit on May/04/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT
SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/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 [AA05597]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496584
Page 85 of 337
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/4/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496585
Page 86 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496586
Page 87 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496587
Page 88 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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: [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496588
Page 89 of 337
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Pain at inject
ion site May/24/2021
18:00 NO
End Date Time:
May/26/2021 UN
K:UNK
Repeating
Pages
2.ADVERSE
EVENT 2 Pain at inject
ion site Jun/14/2021 1
8:00 NO
End Date Time:
Jun/16/2021 UNK:
UNK
Repeating
Pages
3.ADVERSE
EVENT 3 Muscle Pain Jun/14/2021 1
8:00 NO
End Date Time:
Jun/16/2021 UNK:
UNK
Repeating
Pages
4.ADVERSE
EVENT 4 Generalized j
oint Pain Jun/14/2021 1
8:00 NO
End Date Time:
Jun/16/2021 UNK:
UNK
Repeating
Pages
5.ADVERSE
EVENT 5 Fever Jun/15/2021
UNK:UNK NO
End Date Time:
Jun/15/2021 UNK:
UNKRepeating
Pages
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496589
Page 90 of 337
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Event
Still OngoingForm Instan
ce
6.ADVERSE
EVENT 6 Fatigue Jun/14/2021 1
8:00 NO
End Date Time:
Jun/16/2021 UNK:
UNK
Repeating
Pages
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496590
Page 91 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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)[Pain at injection site]
4.Start Date Time: May/24/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
May/26/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496591
Page 92 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
12.Was a Non-Drug Treatment
given?NO
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496592
Page 93 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496593
Page 94 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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)[Pain at injection site]
4.Start Date Time: Jun/14/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/16/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496594
Page 95 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
12.Was a Non-Drug Treatment
given?NO
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496595
Page 96 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496596
Page 97 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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)[Muscle Pain]
4.Start Date Time: Jun/14/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/16/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496597
Page 98 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
12.Was a Non-Drug Treatment
given?NO
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496598
Page 99 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496599
Page 100 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Generalized joint Pain]
4.Start Date Time: Jun/14/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/16/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496600
Page 101 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
12.Was a Non-Drug Treatment
given?NO
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496601
Page 102 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496602
Page 103 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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)[Fever]
4.Start Date Time: Jun/15/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/15/2021 UNK:UNK
6.Toxicity Grade: 1
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496603
Page 104 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
12.Was a Non-Drug Treatment
given?NO
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496604
Page 105 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496605
Page 106 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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)[Fatigue]
4.Start Date Time: Jun/14/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/16/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496606
Page 107 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
12.Was a Non-Drug Treatment
given?NO
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496607
Page 108 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496608
Page 109 of 337
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496609
Page 110 of 337
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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[ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496610
Page 111 of 337
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496611
Page 112 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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: //
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496612
Page 113 of 337
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496613
Page 114 of 337
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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?
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496614
Page 115 of 337
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496615
Page 116 of 337
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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?
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496616
Page 117 of 337
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496617
Page 118 of 337
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496618
Page 119 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496619
Page 120 of 337
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496620
Page 121 of 337
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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: [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496621
Page 122 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/24/2021
2.Erroneous Visit
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496622
Page 123 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/24/2021
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496623
Page 124 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496624
Page 125 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/24/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496625
Page 126 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/24/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496626
Page 127 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/24/2021
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 [BTFLJ6]
5.bSample ID [BTFLJ7]
5.cSample ID [BVCKYH]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496627
Page 128 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/24/2021
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 [BTFLJ5]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496628
Page 129 of 337
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/24/2021 15:13
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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496629
Page 130 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jun/14/2021
2.Erroneous Visit
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496630
Page 131 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/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:
Not Done: NOT DONE
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496631
Page 132 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/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 [BTFLML]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496632
Page 133 of 337
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/14/2021 15:33
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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496633
Page 134 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jul/13/2021
2.Erroneous Visit
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496634
Page 135 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/13/2021
3.Comments: [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496635
Page 136 of 337
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496636
Page 137 of 337
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496637
Page 138 of 337
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496638
Page 139 of 337
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496639
Page 140 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/13/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496640
Page 141 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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/4/2021
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496641
Page 142 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496642
Page 143 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496643
Page 144 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormDec-15-2020 16:01:40 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496644
Page 145 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJul-21-2021 16:58:10 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496645
Page 146 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Jul-21-2021 16:58:10 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496646
Page 147 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Jul-21-2021 16:58:10 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496647
Page 148 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Jul-21-2021 16:58:10 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496648
Page 149 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Jul-21-2021 16:58:10 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496649
Page 150 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
5Jul-21-2021 16:58:10 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496650
Page 151 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
6Jul-21-2021 16:58:10 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496651
Page 152 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
7Jul-21-2021 16:58:10 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496652
Page 153 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
8Jul-21-2021 16:58:10 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496653
Page 154 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
9Jul-21-2021 16:58:10 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496654
Page 155 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMay-24-2021 15:46:42 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496655
Page 156 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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 Mar-22-2021 11:04:32 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shelly
Senders Approved Mar-10-2021 23:10:44 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, ShellySenders, 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.
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2022-5812-0496656
Page 157 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Dec-15-2020
16:00:45
(UTC-05:00) Eastern
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
Dec-15-2020
16:00:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496657
Page 158 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-15-2020
16:00:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Obta
ined
Dec/15/2020Initial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496658
Page 159 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject ID
Date Location User Value Reason
Dec-15-2020
16:00:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
11501210Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Dec-15-2020
16:00:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
/2008Enrollment Entry
3. Sex:
Date Location User Value Reason
Dec-15-2020
16:01:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Dec-15-2020
16:01:06
(UTC-05:00) EasternACV0PF
EINFP60
00 Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORIInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496659
Page 160 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada) GIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Dec-15-2020
16:01:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
WHITEInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496660
Page 161 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-15-2020
16:01:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/15/2020Initial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496661
Page 162 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Dec-15-2020
16:02:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-15-2020
16:02:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Dec-15-2020
16:02:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496662
Page 163 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.a
Date Location User Value Reason
Dec-15-2020
16:02:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Seasonal All
ergies
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Dec-15-2020
16:02:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-15-2020
16:02:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Seasonal AllergiesInitial Entry
1.a Start Date:
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496663
Page 164 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Dec-15-2020
16:02:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Dec-15-2020
16:02:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Dec-15-2020
16:03:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Premenarc
hal
Start Date: Nov/UNK/
2020
Ongoing: YESInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496664
Page 165 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.b Line/MH Number:
Date Location User Value Reason
Dec-15-2020
16:03:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-15-2020
16:03:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
PremenarchalInitial Entry
1.b Start Date:
Date Location User Value Reason
Dec-15-2020
16:03:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Nov/UNK/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Dec-15-2020
16:03:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a035\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-2022-5812-0496665
Page 166 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Dec-15-2020
16:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
The subject is NOT known t
o be HIV POSITIVEInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496666
Page 167 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Dec-15-2020
16:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Dec-15-2020
16:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
86.1Initial Entry
3. Unit:
Date Location User Value Reason
Dec-15-2020
16:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Dec-15-2020
16:03:38ACV0PF
EINFP60Data Entry:
59.0Initial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496667
Page 168 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00) Eastern
Time (US & Canada)00
5. Unit:
Date Location User Value Reason
Dec-15-2020
16:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Dec-15-2020
16:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
17.4Initial Entry
7.a
Date Location User Value Reason
Dec-15-2020
16:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identifi
er::1
Temperature: 98.0
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
090177e19891a035\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-2022-5812-0496668
Page 169 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.a Record Identifier:
Date Location User Value Reason
Dec-15-2020
16:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Dec-15-2020
16:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Dec-15-2020
16:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Dec-15-2020
16:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496669
Page 170 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-15-2020
16:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-15-2020
16:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-15-2020
16:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-15-2020
16:03:51ACV0PF
EINFP60auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496670
Page 171 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00) Eastern
Time (US & Canada)00
5. Specimen Type:
Date Location User Value Reason
Dec-15-2020
16:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Dec-15-2020
16:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-15-2020
16:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
113Initial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496671
Page 172 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
6.a Test:
Date Location User Value Reason
Dec-15-2020
16:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Not Done:
Date Location User Value Reason
Dec-15-2020
16:03:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOT DONEInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496672
Page 173 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Dec-15-2020
16:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Dec/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Dec-15-2020
16:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
22400Initial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496673
Page 174 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-15-2020
16:04:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-15-2020
16:04:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-15-2020
16:04:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-15-2020
16:04:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496674
Page 175 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
correct as
appropriate.
Dec-15-2020
16:04:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Dec/15/2020Initial Entry
5.a
Date Location User Value Reason
Dec-15-2020
16:04:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRD38VInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-15-2020
16:04:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BRD38VInitial Entry
5.b
Date Location User Value Reason
Dec-15-2020
16:04:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRD38WInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496675
Page 176 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Dec-15-2020
16:04:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BRD38WInitial Entry
5.c
Date Location User Value Reason
Dec-15-2020
16:04:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BLB0RXInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-15-2020
16:04:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BLB0RXInitial Entry
090177e19891a035\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-2022-5812-0496676
Page 177 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-15-2020
16:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-15-2020
16:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-15-2020
16:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-15-2020
16:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496677
Page 178 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
correct as
appropriate.
Dec-15-2020
16:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Dec/15/2020Initial Entry
5.a
Date Location User Value Reason
Dec-15-2020
16:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRD38TInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-15-2020
16:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BRD38TInitial Entry
090177e19891a035\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-2022-5812-0496678
Page 179 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-15-2020
16:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-15-2020
16:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-15-2020
16:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-15-2020
16:05:20
(UTC-05:00) EasternACV0PF
EINFP60
00 Data Entry:
Dec/15/2020 15:10Initial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496679
Page 180 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
5. Anatomical Location:
Date Location User Value Reason
Dec-15-2020
16:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-15-2020
16:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-15-2020
16:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-15-2020
16:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496680
Page 181 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Dec-15-2020
16:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496681
Page 182 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Dec-15-2020
16:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED F
OR THIS SUBJECTInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496682
Page 183 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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-07-2021
12:14:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/7/2021Initial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496683
Page 184 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
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-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
090177e19891a035\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-2022-5812-0496684
Page 185 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496685
Page 186 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
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-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was comp
leted?:NOInitial Entry
090177e19891a035\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-2022-5812-0496686
Page 187 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
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-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
090177e19891a035\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-2022-5812-0496687
Page 188 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
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-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e19891a035\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-2022-5812-0496688
Page 189 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
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-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
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 Sub
ject Diary was compl
eted?:NOInitial Entry
090177e19891a035\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-2022-5812-0496689
Page 190 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
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-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
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 la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e19891a035\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-2022-5812-0496690
Page 191 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.g Symptom:
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED MU
SCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT
PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NOInitial Entry
090177e19891a035\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-2022-5812-0496691
Page 192 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.h Symptom:
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
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-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Jan-07-2021 12:15:17
(UTC-05:00) Eastern
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-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
090177e19891a035\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-2022-5812-0496692
Page 193 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.a
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
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
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
090177e19891a035\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-2022-5812-0496693
Page 194 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
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-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
090177e19891a035\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-2022-5812-0496694
Page 195 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reac
tion::PAIN
AT IN
JECTI
ON SI
TE
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-07-2021
12:15:17
(UTC-05:00) Eastern
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-07-2021
12:15:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a035\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-2022-5812-0496695
Page 196 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-07-2021
12:15:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/7/2021Initial Entry
2.a
Date Location User Value Reason
Jan-07-2021
12:15:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identifi
er::1
Temperature: 97.6
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-07-2021
12:15:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
2.a Temperature:
090177e19891a035\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-2022-5812-0496696
Page 197 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Jan-07-2021
12:15:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Jan-07-2021
12:15:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Jan-07-2021
12:15:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a035\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-2022-5812-0496697
Page 198 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-07-2021 12:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-07-2021 12:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-07-2021
12:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/7/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-07-2021 12:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496698
Page 199 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5. Specimen Type:
Date Location User Value Reason
Jan-07-2021 12:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-07-2021 12:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonadot
ropin Beta_PX
113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-07-2021 12:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-07-2021 ACV0PF Data Entry: Initial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496699
Page 200 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
12:16:06
(UTC-05:00) Eastern
Time (US & Canada)EINFP60
00 Choriogonadotropin Beta_P
X113
6.a Not Done:
Date Location User Value Reason
Jan-07-2021
12:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOT DONEInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496700
Page 201 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-07-2021 12:16:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-07-2021 12:16:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-07-2021
12:16:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-07-2021
12:16:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496701
Page 202 of 337
***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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-07-2021
12:16:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/7/2021Initial Entry
5.a
Date Location User Value Reason
Jan-07-2021
12:16:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BPTYBJInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-07-2021
12:16:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BPTYBJInitial Entry
090177e19891a035\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-2022-5812-0496702
Page 203 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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-07-2021
12:16:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-07-2021 12:16:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-07-2021 12:16:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-07-2021
12:16:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/7/2021 11:38Initial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496703
Page 204 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5. Anatomical Location:
Date Location User Value Reason
Jan-07-2021 12:16:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-07-2021
12:16:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-07-2021 12:16:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-07-2021 12:16:42
(UTC-05:00) Eastern
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
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496704
Page 205 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-07-2021
12:16:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496705
Page 206 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021
11:49:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/4/2021Initial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496706
Page 207 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 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
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
090177e19891a035\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-2022-5812-0496707
Page 208 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496708
Page 209 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was comp
leted?:NOInitial Entry
090177e19891a035\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-2022-5812-0496709
Page 210 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
OInitial Entry
090177e19891a035\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-2022-5812-0496710
Page 211 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
090177e19891a035\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-2022-5812-0496711
Page 212 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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 Sub
ject Diary was compl
eted?:NOInitial Entry
090177e19891a035\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-2022-5812-0496712
Page 213 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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 la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
090177e19891a035\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-2022-5812-0496713
Page 214 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.g Symptom:
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT
PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NOInitial Entry
090177e19891a035\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-2022-5812-0496714
Page 215 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.h Symptom:
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
090177e19891a035\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-2022-5812-0496715
Page 216 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.a
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
090177e19891a035\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-2022-5812-0496716
Page 217 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::SW
ELL
ING
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
090177e19891a035\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-2022-5812-0496717
Page 218 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reac
tion::PAIN
AT IN
JECTI
ON SI
TE
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
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
Feb-04-2021
11:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a035\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-2022-5812-0496718
Page 219 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-04-2021
11:49:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-04-2021
11:49:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-04-2021
11:50:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-04-2021
11:49:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496719
Page 220 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
correct as
appropriate.
Feb-04-2021
11:49:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Feb/4/2021Initial Entry
5.a
Date Location User Value Reason
Feb-04-2021
11:50:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRF9S1Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-04-2021
11:50:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BRF9S1Initial Entry
5.b
Date Location User Value Reason
Feb-04-2021
11:50:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRF9S2Initial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496720
Page 221 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Feb-04-2021
11:50:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BRF9S2Initial Entry
5.c
Date Location User Value Reason
Feb-04-2021
11:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BPMDLNInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-04-2021
11:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BPMDLNInitial Entry
090177e19891a035\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-2022-5812-0496721
Page 222 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jul-21-2021
16:58:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Deleted Close Auto
Query
Jul-21-2021
16:57:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms form
is missing.
Please review
and update as
appropriate.
Jul-21-2021
16:57:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal Swab
Self and Nasal
Swab are
missing. Please
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496722
Page 223 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
update as
appropriate.
Jul-21-2021
16:57:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jul/21/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jul-21-2021 16:57:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496723
Page 224 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jul/21/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jul/15/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NO
Date of Last Symptom Res
olved:
Jul/21/2021Initial Entry
4.a
Date Location User Value Reason
090177e19891a035\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-2022-5812-0496724
Page 225 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptoms: FEVE
R
Symptom Present
:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom
s:NEW OR INCR
EASED COUG
H
Symptom
Present:YESInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496725
Page 226 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.b Symptoms:
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR INCREASED CO
UGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sympt
oms:NEW OR INCRE
ASED SHORTNE
SS OF BREATH
Sympt
om Pre
sent:NOInitial Entry
090177e19891a035\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-2022-5812-0496726
Page 227 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.c Symptoms:
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR INCREASED SH
ORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptoms: CHILL
S
Symptom Present
:NOInitial Entry
090177e19891a035\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-2022-5812-0496727
Page 228 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.d Symptoms:
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:NOInitial Entry
090177e19891a035\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-2022-5812-0496728
Page 229 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.e Symptoms:
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR INCREASED MU
SCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SME
LL
Sympto
m Prese
nt:NOInitial Entry
090177e19891a035\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-2022-5812-0496729
Page 230 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.f Symptoms:
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW LOSS OF TASTE OR
SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE TH
ROAT
Sympto
m Prese
nt:NOInitial Entry
090177e19891a035\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-2022-5812-0496730
Page 231 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.g Symptoms:
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR INCREASED SO
RE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptoms: DIARRH
EA
Symptom Pres
ent:NOInitial Entry
090177e19891a035\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-2022-5812-0496731
Page 232 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.h Symptoms:
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
090177e19891a035\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-2022-5812-0496732
Page 233 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
4.i Symptoms:
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Jul-21-2021
16:57:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Jul-21-2021
16:57:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptoms -
Other:Nasal Cong
estionInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Jul-21-2021
16:57:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Nasal CongestionInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496733
Page 234 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 30-Apr-2021 01:47 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b
Date Location User Value Reason
Jul-21-2021
16:58:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptoms - Ot
her:Runny no
seInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Jul-21-2021
16:58:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Runny noseInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496734
Page 235 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Jul-21-2021
16:58:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
2. Specimen Type:
Date Location User Value Reason
Jul-21-2021
16:58:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Jul-21-2021
16:58:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Jul-21-2021
16:58:10ACV0PF
EINFP60Data Entry:
Not ApplicableInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496735
Page 236 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00) Eastern
Time (US & Canada)00
5. Device Type:
Date Location User Value Reason
Jul-21-2021
16:58:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
6. Trade Name:
Date Location User Value Reason
Jul-21-2021
16:58:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
7. Test Result:
Date Location User Value Reason
Jul-21-2021
16:58:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Jul-21-2021
16:58:10ACV0PF
EINFP60Data Entry:
Not ApplicableInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0496736
Page 237 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00) Eastern
Time (US & Canada)00
9. Trade Name Other, Specify:
Date Location User Value Reason
Jul-21-2021
16:58:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not ApplicableInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496737
Page 238 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-21-2021 16:58:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-21-2021 16:58:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-21-2021
16:58:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jul-21-2021
16:58:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496738
Page 239 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jul-21-2021
16:58:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jul/21/2021Initial Entry
5.a
Date Location User Value Reason
Jul-21-2021
16:58:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: RR27093Initial Entry
5.a Sample ID
Date Location User Value Reason
Jul-21-2021
16:58:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
RR27093Initial Entry
090177e19891a035\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-2022-5812-0496739
Page 240 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jul-21-2021 16:58:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jul-21-2021 16:58:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jul-21-2021
16:58:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide
reason:
Date Location User Value Reason
Jul-21-2021
16:58:56
(UTC-05:00) EasternACV0PF
EINFP60
00 Data Entry:
self swab onlyInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2022-5812-0496740
Page 241 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0496741
Page 242 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.a
Date Location User Value Reason
Jul-21-2021
16:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Vis
its or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Jul-21-2021
16:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Jul-21-2021
16:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
090177e19891a035\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-2022-5812-0496742
Page 243 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jul/21/2021Form: HEALTH CARE UTILIZATION - eCRF Audit
Trail History
Form Version: 30-Apr-2021 01:37 Form Status: Data Complete
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501210 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jul-21-2021
16:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Type of Practit
ioner:EMERGE
NCY ROO
M
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Jul-21-2021
16:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Jul-21-2021
16:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Jul-21-2021
16:59:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Type of Prac
titioner:PRIMARY
CARE PHY
SICIANInitial Entry
090177e19891a035\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (
…[truncated]