125742 S1 M5 CRF c4591001 1150 11501153

Document text

Page 1 of 180
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version06 OCT 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813375
Page 2 of 180
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Nov/18/2020
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813376
Page 3 of 180
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11501153]
2.Birth Date: /2003
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813377
Page 4 of 180
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/18/2020
2.Erroneous Visit
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813378
Page 5 of 180
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813379
Page 6 of 180
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathNov/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813380
Page 7 of 180
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Vitamin D Deficiency]
Start Date: UNK/UNK/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety Disorder]
Start Date: Oct/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Major Depressive Disorder]
Start Date: Oct/UNK/2017
Ongoing: YES
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813381
Page 8 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Dysthymic Disorder]
Start Date: UNK/UNK/2018
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Adjustment Disorder]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813382
Page 9 of 180
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813383
Page 10 of 180
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Nov/18/2020
2.Weight: [112.6]
3.Unit: LB
4.Height: [64.5]
5.Unit: in
6.Body Mass Index: [19.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813384
Page 11 of 180
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/18/2020
2.Randomization Number: [116431]
3.Randomization Group: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813385
Page 12 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/18/2020
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 [BRD327]
5.bSample ID [BLB0LS]
5.cSample ID [BLB0LT]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813386
Page 13 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/18/2020
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 [BRD326]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813387
Page 14 of 180
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Nov/18/2020 14:14
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
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813388
Page 15 of 180
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813389
Page 16 of 180
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L 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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/11/2020
2.Erroneous Visit
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813390
Page 17 of 180
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813391
Page 18 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813392
Page 19 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813393
Page 20 of 180
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Dec/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813394
Page 21 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/11/2020
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 [BRD37J]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813395
Page 22 of 180
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L 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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Dec/11/2020 17:00
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
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813396
Page 23 of 180
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L 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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813397
Page 24 of 180
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813398
Page 25 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813399
Page 26 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813400
Page 27 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/8/2021
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 [BPTYCB]
5.bSample ID [BPMDDW]
5.cSample ID [BPMDDX]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813401
Page 28 of 180
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813402
Page 29 of 180
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813403
Page 30 of 180
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813404
Page 31 of 180
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813405
Page 32 of 180
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813406
Page 33 of 180
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813407
Page 34 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813408
Page 35 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813409
Page 36 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813410
Page 37 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813411
Page 38 of 180
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still
ongoing?
6.Toxicity Grade:
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).
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813412
Page 39 of 180
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with
Study Treatment:
11.Was a Concomitant
Medication given?
12.Was a Non-Drug Treatment
given?
13.What was the outcome of
this adverse event?:
14.Did the adverse event cause
the subject to be
discontinued from the
study?
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813413
Page 40 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813414
Page 41 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813415
Page 42 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813416
Page 43 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813417
Page 44 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813418
Page 45 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813419
Page 46 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813420
Page 47 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813421
Page 48 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813422
Page 49 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813423
Page 50 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813424
Page 51 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813425
Page 52 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813426
Page 53 of 180
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813427
Page 54 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813428
Page 55 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813429
Page 56 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813430
Page 57 of 180
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Jan/8/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813431
Page 58 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/9/2021
2.Erroneous Visit
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813432
Page 59 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813433
Page 60 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813434
Page 61 of 180
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/9/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813435
Page 62 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813436
Page 63 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813437
Page 64 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813438
Page 65 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/24/2021
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813439
Page 66 of 180
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813440
Page 67 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/24/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813441
Page 68 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/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 [BRNCPF]
5.bSample ID [BS2CYZ]
5.cSample ID [BS2CZ0]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813442
Page 69 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/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 [BRNCPD]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813443
Page 70 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/24/2021 15:32
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
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813444
Page 71 of 180
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813445
Page 72 of 180
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813446
Page 73 of 180
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vaccination
1.Was there a temporary
delay of vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813447
Page 74 of 180
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813448
Page 75 of 180
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813449
Page 76 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813450
Page 77 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813451
Page 78 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813452
Page 79 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813453
Page 80 of 180
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813454
Page 81 of 180
***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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Jan/8/2021
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813455
Page 82 of 180
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813456
Page 83 of 180
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Shelly
Senders Approved Mar-10-2021 22:52:31 (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.
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813457
Page 84 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormNov-18-2020 16:00:27 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813458
Page 85 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormFeb-24-2021 16:13:00 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813459
Page 86 of 180
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Shelly
Senders Approved Mar-10-2021 22:52:31 (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.
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813460
Page 87 of 180
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Nov-18-2020
15:59:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Nov-18-2020
15:59:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813461
Page 88 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-18-2020
15:59:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Nov/18/2020Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813462
Page 89 of 180
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-18-2020
15:59:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11501153Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Nov-18-2020
15:59:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2003Enrollment
Entry
3. Sex:
Date Location User Value Reason
Nov-18-2020
16:00:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813463
Page 90 of 180
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-18-2020
16:00:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-18-2020
16:00:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813464
Page 91 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-18-2020
16:00:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/18/2020Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813465
Page 92 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Nov-18-2020
16:00:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-18-2020
16:00:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-18-2020
16:00:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813466
Page 93 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Nov-18-2020
16:01:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Vitamin D
Deficienc
y
Start Date
:UNK/UN
K/2017
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-18-2020
16:01:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-18-2020
16:01:05
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Vitamin D Deficienc
yInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813467
Page 94 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
1.a Start Date:
Date Location User Value Reason
Nov-18-2020
16:01:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-18-2020
16:01:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Nov-18-2020
16:01:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:2
Medical
History T
erm:Anxiet
y Disor
der
Start Dat
e:Oct/U
NK/20
17Transcription
Error
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813468
Page 95 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Ongoing: YES
Nov-18-2020
16:01:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History T
erm:Anxiet
y Disor
der
Start Dat
e:UNK/
UNK/2
017
Ongoing: YESInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813469
Page 96 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Line/MH Number:
Date Location User Value Reason
Nov-18-2020
16:01:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-18-2020
16:01:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Anxiety DisorderInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-18-2020
16:01:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/UNK/2017Transcription
Error
Nov-18-2020
16:01:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813470
Page 97 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Ongoing:
Date Location User Value Reason
Nov-18-2020
16:01:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Nov-18-2020
16:01:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical
History T
erm:Major Dep
ressive Dis
order
Start Dat
e:Oct/UNK/
2017
Ongoing: YESInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813471
Page 98 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.c Line/MH Number:
Date Location User Value Reason
Nov-18-2020
16:01:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-20-2020
06:55:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response
satisfies query
Nov-19-2020
14:17:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered yes inclusion
number 3 was
reviewed by PI
and subject is
deemed suitable
for study
Nov-19-2020
10:27:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY:
Subject is
reported to
suffer from
major
depressive
disorder,
adjustment
disorder,
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0813472
Page 99 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
dysthymic
disorder and
anxiety
disorder. Please
confirm
inclusion 3 and
exclusion 1 was
reviewed and
subject deemed
suitable for trial
Nov-18-2020
16:01:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Major Depressive
DisorderInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-18-2020
16:01:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/UNK/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-18-2020
16:01:45
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813473
Page 100 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
1.d
Date Location User Value Reason
Nov-18-2020
16:02:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical Hi
story Term
:Dysthymi
c Disorde
r
Start Date: UNK/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813474
Page 101 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d Line/MH Number:
Date Location User Value Reason
Nov-18-2020
16:02:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-18-2020
16:02:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dysthymic DisorderInitial Entry
1.d Start Date:
Date Location User Value Reason
Nov-18-2020
16:02:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Nov-18-2020
16:02:15ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813475
Page 102 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
1.e
Date Location User Value Reason
Nov-18-2020
16:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical Hi
story Term
:Adjustme
nt Disord
er
Start Date: UNK/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0813476
Page 103 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.e Line/MH Number:
Date Location User Value Reason
Nov-18-2020
16:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-18-2020
16:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Adjustment DisorderInitial Entry
1.e Start Date:
Date Location User Value Reason
Nov-18-2020
16:02:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Nov-18-2020
16:02:32ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813477
Page 104 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0813478
Page 105 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-18-2020
16:02:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT k
nown to be HIV POS
ITIVEInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813479
Page 106 of 180
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Nov-18-2020
16:03:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-18-2020
16:03:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
112.6Initial Entry
3. Unit:
Date Location User Value Reason
Nov-18-2020
16:03:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813480
Page 107 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-18-2020
16:03:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
64.5Initial Entry
5. Unit:
Date Location User Value Reason
Nov-18-2020
16:03:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-18-2020
16:03:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19.0Initial Entry
7.a
Date Location User Value Reason
Nov-18-2020
16:03:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.2Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813481
Page 108 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Nov-18-2020
16:03:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-18-2020
16:03:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-18-2020
16:03:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813482
Page 109 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.a Temperature Location:
Date Location User Value Reason
Nov-18-2020
16:03:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813483
Page 110 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-18-2020
16:03:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-18-2020
16:03:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
116431Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813484
Page 111 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-18-2020
16:03:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-18-2020
16:03:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-18-2020
16:04:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-18-2020
16:03:43
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813485
Page 112 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-18-2020
16:03:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/18/2020Initial Entry
5.a
Date Location User Value Reason
Nov-18-2020
16:04:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRD32
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-18-2020
16:04:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRD327Initial Entry
5.b
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813486
Page 113 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-18-2020
16:04:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BLB0L
SInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-18-2020
16:04:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLB0LSInitial Entry
5.c
Date Location User Value Reason
Nov-18-2020
16:04:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BLB0L
TInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-18-2020
16:04:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLB0LTInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813487
Page 114 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-18-2020
16:04:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-18-2020
16:04:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-18-2020
16:04:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-18-2020
16:04:28
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813488
Page 115 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-18-2020
16:04:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/18/2020Initial Entry
5.a
Date Location User Value Reason
Nov-18-2020
16:04:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRD32
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-18-2020
16:04:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRD326Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813489
Page 116 of 180
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-18-2020
16:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-18-2020
16:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-18-2020
16:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813490
Page 117 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-18-2020
16:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/18/2020 14:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-18-2020
16:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-18-2020
16:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-18-2020
16:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813491
Page 118 of 180
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-18-2020
16:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-18-2020
16:05:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813492
Page 119 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-18-2020
16:05:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813493
Page 120 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-11-2020
18:34:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/11/2020Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813494
Page 121 of 180
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813495
Page 122 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813496
Page 123 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.b Symptom:
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813497
Page 124 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.c Symptom:
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Symptom:: C
HIInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813498
Page 125 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)L
LS
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
O
2.d Symptom:
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813499
Page 126 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813500
Page 127 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813501
Page 128 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.g
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
IN
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NOInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813502
Page 129 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.g Symptom:
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAINInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813503
Page 130 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NO
2.h Symptom:
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-11-2020
18:34:42ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813504
Page 131 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
4. Injection Site Body Side:
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions prese
nt on the last day
the Subject Diar
y was completed
?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813505
Page 132 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::SW
EL
LI
NG
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was comple
ted?:NOInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813506
Page 133 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTIO
N SI
TEInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813507
Page 134 of 180
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-11-2020
18:34:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813508
Page 135 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Dec-11-2020
18:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/11/2020Initial Entry
2.a
Date Location User Value Reason
Dec-11-2020
18:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:98.1
Temperatur
e Unit:F
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-11-2020
18:34:59
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813509
Page 136 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
2.a Temperature:
Date Location User Value Reason
Dec-11-2020
18:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-11-2020
18:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Dec-11-2020
18:34:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813510
Page 137 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-11-2020
18:35:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-11-2020
18:35:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-11-2020
18:35:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-11-2020
18:35:15
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813511
Page 138 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Dec-11-2020
18:35:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/11/2020Initial Entry
5.a
Date Location User Value Reason
Dec-11-2020
18:35:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRD37JInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-11-2020
18:35:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRD37JInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813512
Page 139 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-11-2020
18:36:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-11-2020
18:36:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-11-2020
18:36:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813513
Page 140 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-11-2020
18:36:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/11/2020 17:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-11-2020
18:36:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-11-2020
18:36:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-11-2020
18:36:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813514
Page 141 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-11-2020
18:36:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Dec-11-2020
18:36:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813515
Page 142 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-13-2021
03:13:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Jan-12-2021
08:29:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Original value
is correct
Jan-12-2021
03:34:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
2nd
vaccination.
Please
complete
treatment
disposition
CRF and
update date of
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0813516
Page 143 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
EOT to match
date of visit at
visit 3.
Jan-08-2021
17:52:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0813517
Page 144 of 180
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813518
Page 145 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
OInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813519
Page 146 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.b Symptom:
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813520
Page 147 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NO
2.c Symptom:
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Symptom:: C
HIInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813521
Page 148 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)L
LS
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:N
O
2.d Symptom:
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813522
Page 149 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813523
Page 150 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813524
Page 151 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.g
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
IN
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NOInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813525
Page 152 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
2.g Symptom:
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D MUSCLE 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-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED J
OINT
PAINInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813526
Page 153 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were fever or
systemic sym
ptoms presen
t on the last d
ay the Subjec
t Diary was c
ompleted?:NO
2.h Symptom:
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENE
D JOINT 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-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Jan-08-2021
17:53:21ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813527
Page 154 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
4. Injection Site Body Side:
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::RE
D
NE
SS
Were injection si
te reactions prese
nt on the last day
the Subject Diar
y was completed
?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813528
Page 155 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Re
action::SW
EL
LI
NG
Were injection si
te reactions pres
ent on the last d
ay the Subject D
iary was comple
ted?:NOInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813529
Page 156 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTIO
N SI
TEInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813530
Page 157 of 180
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION
SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-08-2021
17:53:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813531
Page 158 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-08-2021
17:53:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-08-2021
17:53:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-08-2021
17:53:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-08-2021
17:53:36
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813532
Page 159 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-08-2021
17:53:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/8/2021Initial Entry
5.a
Date Location User Value Reason
Jan-08-2021
17:53:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTYCBInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-08-2021
17:53:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPTYCBInitial Entry
5.b
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813533
Page 160 of 180
***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, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-08-2021
17:57:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPMDD
WInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-08-2021
17:57:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPMDDWInitial Entry
5.c
Date Location User Value Reason
Jan-08-2021
17:57:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BPMDD
XInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-08-2021
17:57:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPMDDXInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813534
Page 161 of 180
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-12-2021
08:29:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-12-2021
08:29:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Jan-12-2021
08:29:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813535
Page 162 of 180
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021
15:37:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813536
Page 163 of 180
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-15-2021
15:43:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-12-2021
01:03:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Feb-11-2021
15:37:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0813537
Page 164 of 180
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
complete this
date.
Feb-11-2021
15:37:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible per loc
al/national reco
mmendations a
nd confirmed t
o have received
only placebo at
Vaccination 1/2Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0813538
Page 165 of 180
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-15-2021
15:43:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-15-2021
15:43:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813539
Page 166 of 180
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021
16:12:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/24/2021Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813540
Page 167 of 180
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-24-2021
16:12:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Feb/24/2021Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813541
Page 168 of 180
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-24-2021
16:13:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/24/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-24-2021
16:13:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Feb-24-2021
16:13:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813542
Page 169 of 180
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-24-2021
16:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-24-2021
16:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-24-2021
16:13:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-24-2021
16:13:23
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813543
Page 170 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-24-2021
16:13:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
Feb-24-2021
16:13:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRNCP
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-24-2021
16:13:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRNCPFInitial Entry
5.b
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813544
Page 171 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - 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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-24-2021
16:13:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BS2CY
ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-24-2021
16:13:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS2CYZInitial Entry
5.c
Date Location User Value Reason
Feb-24-2021
16:14:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BS2CZ
0Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-24-2021
16:14:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BS2CZ0Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813545
Page 172 of 180
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-24-2021
16:14:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-24-2021
16:14:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-24-2021
16:14:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-24-2021
16:14:10
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813546
Page 173 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: 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: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-24-2021
16:14:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
Feb-24-2021
16:14:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BRNCP
DInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-24-2021
16:14:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRNCPDInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813547
Page 174 of 180
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-24-2021
16:14:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-24-2021
16:14:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-24-2021
16:14:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813548
Page 175 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-24-2021
16:14:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/24/2021 15:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-24-2021
16:14:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-24-2021
16:14:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-24-2021
16:14:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813549
Page 176 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
8. Actual Dose:
Date Location User Value Reason
Feb-24-2021
16:14:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-24-2021
16:14:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-24-2021
16:14:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-24-2021
16:14:57ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813550
Page 177 of 180
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0813551
Page 178 of 180
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-12-2021
08:29:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-18-2020
16:03:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Nov-18-2020
16:00:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-12-2021
08:29:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Jan/8/2021Initial Entry
Nov-18-2020
16:03:34ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/18/2020Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813552
Page 179 of 180
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
Nov-18-2020
16:00:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/18/2020Initial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0813553
Page 180 of 180
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501153 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Casebook Signature
Date Location User Value Reason
Jan-28-2021
11:36:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f88\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0813554