125742 S1 M5 CRF c4591001 1150 11501022

Document text

Page 1 of 214
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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 version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812324
Page 2 of 214
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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
Aug/19/2020
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812325
Page 3 of 214
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11501022]
2.Birth Date: 1988
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:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812326
Page 4 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/19/2020
2.Erroneous Visit
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812327
Page 5 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812328
Page 6 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/19/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812329
Page 7 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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:[Type 2 Diabetes]
Start Date: Jul/31/2019
Ongoing: YES
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812330
Page 8 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Aug/19/2020
2.Weight: [345.0]
3.Unit: LB
4.Height: [73.0]
5.Unit: in
6.Body Mass Index: [45.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812331
Page 9 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/19/2020
2.Randomization Number: [57299]
3.Randomization Group: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812332
Page 10 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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:
Aug/19/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN6CST]
5.bSample ID [BN6CSV]
5.cSample ID [BN6CSW]
5.dSample ID [BL9RHX]
5.eSample ID [BL9RHY]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812333
Page 11 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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:
Aug/19/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN6CSS]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812334
Page 12 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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: Aug/19/2020 17:29
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812335
Page 13 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812336
Page 14 of 214
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812337
Page 15 of 214
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812338
Page 16 of 214
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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:
Sep/8/2020
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 [BN6D2P]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812339
Page 17 of 214
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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: Sep/8/2020 12:09
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812340
Page 18 of 214
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812341
Page 19 of 214
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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:
Oct/12/2020
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 [BN6D81]
5.bSample ID [BL9RSX]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812342
Page 20 of 214
***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: 11501022 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:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812343
Page 21 of 214
***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: 11501022 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: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812344
Page 22 of 214
***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: 11501022 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 [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812345
Page 23 of 214
***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: 11501022 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 [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812346
Page 24 of 214
***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: 11501022 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?
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812347
Page 25 of 214
***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: 11501022 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:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812348
Page 26 of 214
***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: 11501022 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:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812349
Page 27 of 214
***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: 11501022 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 [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812350
Page 28 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812351
Page 29 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812352
Page 30 of 214
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812353
Page 31 of 214
***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: 11501022 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: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812354
Page 32 of 214
***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: 11501022 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:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812355
Page 33 of 214
***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: 11501022 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 [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812356
Page 34 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Ide
ntifierAdverse Ev
entStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Kidney Ston
es Dec/2/2020 U
NK:UNK NO
End Date Time:
Dec/8/2020 UNK:
UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  Pain at injec
tion site Jan/19/2021 1
8:00 NO
End Date Time:
Jan/20/2021 UNK:
UNK
 Repeating
Pages
 3.ADVERSE
EVENT 3  Fatigue  Jan/19/2021 1
8:00 NO
End Date Time:
Jan/20/2021 UNK:
UNK
 Repeating
Pages
 4.ADVERSE
EVENT 4  Muscle Pain
 Jan/19/2021 1
8:00 NO
End Date Time:
Jan/20/2021 UNK:
UNK
 Repeating
Pages
 5.ADVERSE
EVENT 5  Pain at injec
tion site Feb/9/2021 U
NK:UNK NO
End Date Time:
Feb/10/2021 UNK:
UNKRepeating
Pages
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812357
Page 35 of 214
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Ide
ntifierAdverse Ev
entStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 
 6.ADVERSE
EVENT 6  Headache  Feb/9/2021 U
NK:UNK NO
End Date Time:
Feb/12/2021 UNK:
UNK
 Repeating
Pages
 7.ADVERSE
EVENT 7  Fatigue  Feb/9/2021 U
NK:UNK NO
End Date Time:
Feb/12/2021 UNK:
UNK
 Repeating
Pages
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812358
Page 36 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Kidney Stones]
4.Start Date Time: Dec/2/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/8/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812359
Page 37 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812360
Page 38 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021051527]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812361
Page 39 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Pain at injection site]
4.Start Date Time: Jan/19/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/20/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812362
Page 40 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812363
Page 41 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812364
Page 42 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Fatigue]
4.Start Date Time: Jan/19/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/20/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812365
Page 43 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812366
Page 44 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812367
Page 45 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Muscle Pain]
4.Start Date Time: Jan/19/2021 18:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/20/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812368
Page 46 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812369
Page 47 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812370
Page 48 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Pain at injection site]
4.Start Date Time: Feb/9/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/10/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812371
Page 49 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812372
Page 50 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812373
Page 51 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Headache]
4.Start Date Time: Feb/9/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/12/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812374
Page 52 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812375
Page 53 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812376
Page 54 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Fatigue]
4.Start Date Time: Feb/9/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/12/2021 UNK:UNK
6.Toxicity Grade: 2
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812377
Page 55 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812378
Page 56 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812379
Page 57 of 214
***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: 11501022 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
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812380
Page 58 of 214
***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: 11501022 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[ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812381
Page 59 of 214
***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: 11501022 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
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812382
Page 60 of 214
***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: 11501022 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: //
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812383
Page 61 of 214
***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: 11501022 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
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812384
Page 62 of 214
***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: 11501022 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?
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812385
Page 63 of 214
***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: 11501022 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
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812386
Page 64 of 214
***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: 11501022 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?
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812387
Page 65 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812388
Page 66 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812389
Page 67 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812390
Page 68 of 214
***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: 11501022 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:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812391
Page 69 of 214
***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: 11501022 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?
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812392
Page 70 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812393
Page 71 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812394
Page 72 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812395
Page 73 of 214
***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: 11501022 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
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812396
Page 74 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/18/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812397
Page 75 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812398
Page 76 of 214
***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: 11501022 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: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812399
Page 77 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812400
Page 78 of 214
***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: 11501022 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
Jan/19/2021
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812401
Page 79 of 214
***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: 11501022 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
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812402
Page 80 of 214
***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: 11501022 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 :Jan/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812403
Page 81 of 214
***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: 11501022 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/19/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRF9J3]
5.bSample ID [BPMDGR]
5.cSample ID [BPMDGS]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812404
Page 82 of 214
***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: 11501022 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:
Jan/19/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRF9J4]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812405
Page 83 of 214
***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: 11501022 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: Jan/19/2021 13:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812406
Page 84 of 214
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812407
Page 85 of 214
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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/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 [BRF9T0]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812408
Page 86 of 214
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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/8/2021 13:41
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812409
Page 87 of 214
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812410
Page 88 of 214
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/8/2021
3.Comments: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812411
Page 89 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812412
Page 90 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812413
Page 91 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812414
Page 92 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812415
Page 93 of 214
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/8/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812416
Page 94 of 214
***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: 11501022 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 Oct/12/2020
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812417
Page 95 of 214
***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: 11501022 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
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812418
Page 96 of 214
***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: 11501022 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-09-2021 20:16:41 (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.
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812419
Page 97 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormAug-19-2020 19:53:13
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812420
Page 98 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormJan-19-2021 17:46:00 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812421
Page 99 of 214
***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: 11501022 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-09-2021 20:16:41 (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.
 N/A Feb-08-2021 14:09:48 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shelly
Senders Approved Jan-23-2021 20:19:13 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812422
Page 100 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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.
 N/A Jan-19-2021 17:44:55 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shelly
Senders Approved Oct-28-2020 12:48:12 (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.
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812423
Page 101 of 214
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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
Aug-19-2020
19:52:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-19-2020
19:52:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812424
Page 102 of 214
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-19-2020
19:52:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/19/2020Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812425
Page 103 of 214
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-19-2020
19:52:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-19-2020
19:52:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
11501022Transcription
Error
Aug-19-2020
19:52:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Subject ID is
expected to be
in 8 digits.
Please review.
Aug-19-2020
19:52:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1151022Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-19-2020
19:50:43ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1988Enrollment
Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812426
Page 104 of 214
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
3. Sex:
Date Location User Value Reason
Aug-19-2020
19:52:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-19-2020
19:52:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-19-2020
19:52:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f8b\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-2021-5683-0812427
Page 105 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-19-2020
19:53:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812428
Page 106 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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
Aug-19-2020
19:53:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-19-2020
19:53:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-19-2020
19:53:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812429
Page 107 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Aug-19-2020
19:54:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Type 2
Diabetes
Start Date: Jul/31/2
019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-19-2020
19:54:23
(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
Aug-19-2020
19:54:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type 2 DiabetesInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812430
Page 108 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.a Start Date:
Date Location User Value Reason
Aug-19-2020
19:54:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jul/31/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-19-2020
19:54:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812431
Page 109 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Aug-19-2020
19:54:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-24-2020
06:45:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Per site's
confirmation.
Aug-21-2020
08:01:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answere
dWeight is not
clinically
significant.
Deemed
healthy per
physical.
Aug-21-2020
06:42:11
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:OpenedDM1:
Confirmation
on the out of
range value as
clinically
significant or
090177e196ae2f8b\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-2021-5683-0812432
Page 110 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
not is expected.
Please review
and confirm.
Aug-20-2020
09:49:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answere
dOriginal value
is correct
Aug-20-2020
03:56:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissue
d:OpenedDM: Please
verify the
weight and unit
reported as 345
lb is outside the
normal range
25-136 for kg
or 50-300 for
lb. If correct
kindly confirm
if it is clinically
significant. If
yes please
report
corresponding
event on
medical history
page. Else
clarify.
Aug-19-2020
19:58:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answere
dOriginal value
is correct
090177e196ae2f8b\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-2021-5683-0812433
Page 111 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-19-2020
19:54:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Weight 345 is
outside of
Normal Range
25 - 136 for kg
or 50 - 300 for
lb.
Aug-19-2020
19:54:55
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
345.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-19-2020
19:54:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-19-2020
19:54:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
73.0Initial Entry
5. Unit:
090177e196ae2f8b\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-2021-5683-0812434
Page 112 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-19-2020
19:54:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-19-2020
19:54:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
45.5Initial Entry
7.a
Date Location User Value Reason
Aug-19-2020
19:54:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.9
Temperatu
re Unit:F
Temperatu
re Locatio
n::FORE
HEA
DInitial Entry
7.a Record Identifier:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812435
Page 113 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-19-2020
19:54:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-19-2020
19:54:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-19-2020
19:54:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-19-2020
19:54:55
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2f8b\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-2021-5683-0812436
Page 114 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812437
Page 115 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-19-2020
19:55:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/19/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-19-2020
19:55:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
57299Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812438
Page 116 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020
19:55:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020
19:55:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020
19:55:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-19-2020
19:55:25
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812439
Page 117 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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.
Aug-19-2020
19:55:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020
19:55:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN6CS
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-19-2020
19:55:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6CSTInitial Entry
5.b
090177e196ae2f8b\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-2021-5683-0812440
Page 118 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-19-2020
19:55:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN6CS
VInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-19-2020
19:55:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6CSVInitial Entry
5.c
Date Location User Value Reason
Aug-19-2020
19:55:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN6CS
WInitial Entry
090177e196ae2f8b\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-2021-5683-0812441
Page 119 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c Sample ID
Date Location User Value Reason
Aug-19-2020
19:55:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6CSWInitial Entry
5.d
Date Location User Value Reason
Aug-19-2020
19:56:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BL9RH
XInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-19-2020
19:56:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9RHXInitial Entry
5.e
Date Location User Value Reason
Aug-19-2020
19:57:01ACV0PFEINFP6000  Data Entry:
Sample I BL9RHInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812442
Page 120 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)D: Y
5.e Sample ID
Date Location User Value Reason
Aug-19-2020
19:57:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9RHYInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812443
Page 121 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-19-2020
19:58:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-19-2020
19:58:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-19-2020
19:58:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-19-2020
19:58:32
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812444
Page 122 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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.
Aug-19-2020
19:58:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/19/2020Initial Entry
5.a
Date Location User Value Reason
Aug-19-2020
19:58:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BN6CS
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-19-2020
19:58:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6CSSInitial Entry
090177e196ae2f8b\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-2021-5683-0812445
Page 123 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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
Aug-19-2020
20:00:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-19-2020
20:00:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-19-2020
20:00:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812446
Page 124 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-19-2020
20:00:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/19/2020 17:29Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-19-2020
20:00:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-19-2020
20:00:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-19-2020
20:00:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812447
Page 125 of 214
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-19-2020
20:00:23
(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
Aug-19-2020
20:00:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812448
Page 126 of 214
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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
Aug-19-2020
20:00:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGE
NICITY E-DIARY
NOT COLLECTED
FOR THIS SUBJE
CTInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812449
Page 127 of 214
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-09-2020
09:00:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812450
Page 128 of 214
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-09-2020
09:01:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2.a
Date Location User Value Reason
Sep-09-2020
09:01:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatur
e:98.2
Temperatur
e Unit:F
Temperatur
e Location::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-09-2020
09:01:40
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae2f8b\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-2021-5683-0812451
Page 129 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-09-2020
09:01:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-09-2020
09:01:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-09-2020
09:01:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f8b\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-2021-5683-0812452
Page 130 of 214
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020
09:01:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020
09:01:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020
09:02:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-09-2020
09:01:55
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812453
Page 131 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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.
Sep-09-2020
09:01:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020
09:02:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6D2PInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020
09:02:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6D2PInitial Entry
090177e196ae2f8b\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-2021-5683-0812454
Page 132 of 214
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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
Sep-09-2020
09:04:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-09-2020
09:04:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-09-2020
09:04:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812455
Page 133 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-09-2020
09:04:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020 12:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-09-2020
09:04:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-09-2020
09:04:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-09-2020
09:04:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812456
Page 134 of 214
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-09-2020
09:04:00
(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
Sep-09-2020
09:04:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812457
Page 135 of 214
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020
12:06:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812458
Page 136 of 214
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020
12:06:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020
12:06:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020
12:06:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-13-2020
12:06:45
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812459
Page 137 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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.
Oct-13-2020
12:06:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020
12:06:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BN6D8
1Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020
12:06:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6D81Initial Entry
5.b
Date Location User Value Reason
090177e196ae2f8b\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-2021-5683-0812460
Page 138 of 214
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-13-2020
12:07:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BL9RS
XInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-13-2020
12:07:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9RSXInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812461
Page 139 of 214
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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
Oct-13-2020
12:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020
12:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-13-2020
12:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812462
Page 140 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812463
Page 141 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812464
Page 142 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812465
Page 143 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812466
Page 144 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812467
Page 145 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812468
Page 146 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812469
Page 147 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Kidney StonesInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812470
Page 148 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/2/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/8/2020 UN
K:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
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).
090177e196ae2f8b\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-2021-5683-0812471
Page 149 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Jan-21-2021
04:11:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Kidney
Stones:
Response to
"Is the
adverse event
serious?" is
'Yes' but
"Serious
Adverse
Event
Number" is
blank.
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious eve
nt associated with
congenital anomal
y or birth defect?
NO
Did this serious e
vent result in deat
h?Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812472
Page 150 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
NO
Did this serious e
vent require or pr
olong hospitalizat
ion?
YES
Did this serious e
vent result in pers
istent or significa
nt disability/incap
acity?
NO
Is this serious eve
nt life threatening
?
NO
Other medically i
mportant serious
event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812473
Page 151 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to st
udy treatment(s), t
his event is due to:
OTHER
If Other, specify
:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABL
EInitial Entry
11. Was a Concomitant Medication given?
090177e196ae2f8b\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-2021-5683-0812474
Page 152 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-20-2021
15:06:00
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8b\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-2021-5683-0812475
Page 153 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-21-2021
04:11:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2021051527Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0812476
Page 154 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Pain at injection siteInitial Entry
4. Start Date Time:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812477
Page 155 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/20/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
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
090177e196ae2f8b\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-2021-5683-0812478
Page 156 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2f8b\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-2021-5683-0812479
Page 157 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
090177e196ae2f8b\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-2021-5683-0812480
Page 158 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-08-2021
14:12:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812481
Page 159 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FatigueInitial Entry
4. Start Date Time:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812482
Page 160 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/20/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
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
090177e196ae2f8b\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-2021-5683-0812483
Page 161 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2f8b\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-2021-5683-0812484
Page 162 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
090177e196ae2f8b\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-2021-5683-0812485
Page 163 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-08-2021
14:12:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812486
Page 164 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Muscle PainInitial Entry
4. Start Date Time:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812487
Page 165 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/20/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
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
090177e196ae2f8b\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-2021-5683-0812488
Page 166 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2f8b\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-2021-5683-0812489
Page 167 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
090177e196ae2f8b\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-2021-5683-0812490
Page 168 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-08-2021
14:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812491
Page 169 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Pain at injection siteInitial Entry
4. Start Date Time:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812492
Page 170 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/10/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
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
090177e196ae2f8b\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-2021-5683-0812493
Page 171 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2f8b\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-2021-5683-0812494
Page 172 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
090177e196ae2f8b\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-2021-5683-0812495
Page 173 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-08-2021
10:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812496
Page 174 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
4. Start Date Time:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812497
Page 175 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/12/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
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
090177e196ae2f8b\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-2021-5683-0812498
Page 176 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2f8b\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-2021-5683-0812499
Page 177 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
090177e196ae2f8b\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-2021-5683-0812500
Page 178 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-08-2021
10:12:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812501
Page 179 of 214
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FatigueInitial Entry
4. Start Date Time:
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812502
Page 180 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/9/2021 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/12/2021 UNK
:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
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
090177e196ae2f8b\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-2021-5683-0812503
Page 181 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
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.
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2f8b\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-2021-5683-0812504
Page 182 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RES
OLVEDInitial Entry
090177e196ae2f8b\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-2021-5683-0812505
Page 183 of 214
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-08-2021
10:12:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812506
Page 184 of 214
***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: 11501022 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-19-2021
17:44:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812507
Page 185 of 214
***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: 11501022 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
Jan-19-2021
17:45:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-19-2021
17:45:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candida
teThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-19-2021
17:45:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is will
ing to return for V
accination 3
Participant is:
eligible per loc
al/national rec
ommendations
and confirmedInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812508
Page 186 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
to have receive
d only placebo
at Vaccination
1/2
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812509
Page 187 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-19-2021
17:45:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021
17:45:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBIL
ITY FOR ADDITI
ONAL VACCINAT
IONInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812510
Page 188 of 214
***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: 11501022 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-19-2021
17:45:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812511
Page 189 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-19-2021
17:45:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Jan/19/2021Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812512
Page 190 of 214
***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: 11501022 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-19-2021
17:46:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-19-2021
17:46:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Jan-19-2021
17:46:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812513
Page 191 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021
17:46:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021
17:46:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-21-2021
03:32:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Jan-20-2021
08:30:34
(UTC-05:00)ACV0PFEINFP6000  Query 1: Answere
dChanged data
per query
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812514
Page 192 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)
Jan-20-2021
07:26:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-19-2021
17:46:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-19-2021
17:46:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Jan/19/2021Initial Entry
5.a
Date Location User Value Reason
Jan-20-2021
08:31:22
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Sample I
D:BRF9J
3Initial Entry
090177e196ae2f8b\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-2021-5683-0812515
Page 193 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
5.a Sample ID
Date Location User Value Reason
Jan-20-2021
08:31:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRF9J3Initial Entry
5.b
Date Location User Value Reason
Jan-20-2021
08:31:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPMD
GRInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-20-2021
08:31:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPMDGRInitial Entry
5.c
Date Location User Value Reason
090177e196ae2f8b\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-2021-5683-0812516
Page 194 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-20-2021
08:31:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BPMD
GSInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-20-2021
08:31:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPMDGSInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812517
Page 195 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021
17:47:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021
17:47:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-21-2021
00:57:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Jan-20-2021
08:30:49
(UTC-05:00)ACV0PFEINFP6000  Query 1: Answere
dChanged data
per query
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812518
Page 196 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US
& Canada)
Jan-20-2021
07:26:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-19-2021
17:47:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-19-2021
17:47:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Jan/19/2021Initial Entry
5.a
Date Location User Value Reason
Jan-20-2021
08:31:59
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Sample I
D:BRF9J
4Initial Entry
090177e196ae2f8b\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-2021-5683-0812519
Page 197 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada)
5.a Sample ID
Date Location User Value Reason
Jan-20-2021
08:31:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRF9J4Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812520
Page 198 of 214
***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: 11501022 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
Jan-19-2021
17:47:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-19-2021
17:47:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-19-2021
17:47:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812521
Page 199 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-19-2021
17:47:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021 13:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-19-2021
17:47:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-19-2021
17:47:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Jan-19-2021
17:47:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812522
Page 200 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
8. Actual Dose:
Date Location User Value Reason
Jan-19-2021
17:47:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-19-2021
17:47:56
(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
Jan-19-2021
17:47:56
(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
Jan-19-2021
17:47:56ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812523
Page 201 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812524
Page 202 of 214
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 11501022 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-08-2021
14:09:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/8/2021Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812525
Page 203 of 214
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-08-2021
14:09:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-08-2021
14:09:57
(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-08-2021
14:10:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-08-2021
14:09:57
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812526
Page 204 of 214
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 11501022 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-08-2021
14:09:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/8/2021Initial Entry
5.a
Date Location User Value Reason
Feb-08-2021
14:10:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRF9T
0Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-08-2021
14:10:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRF9T0Initial Entry
090177e196ae2f8b\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-2021-5683-0812527
Page 205 of 214
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 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: 11501022 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-08-2021
14:11:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-08-2021
14:11:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-08-2021
14:11:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812528
Page 206 of 214
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-08-2021
14:11:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/8/2021 13:41Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-08-2021
14:11:12
(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-08-2021
14:11:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Feb-08-2021
14:11:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812529
Page 207 of 214
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
8. Actual Dose:
Date Location User Value Reason
Feb-08-2021
14:11:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-08-2021
14:11:12
(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-08-2021
14:11:12
(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-08-2021
14:11:12ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812530
Page 208 of 214
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812531
Page 209 of 214
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-08-2021
10:08:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/8/2021Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812532
Page 210 of 214
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - 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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-08-2021
10:08:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-08-2021
10:08:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Mar/8/2021Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812533
Page 211 of 214
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501022 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
Mar-08-2021
10:08:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/8/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-08-2021
10:08:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREAT
MENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-08-2021
10:08:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812534
Page 212 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-13-2020
12:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-19-2020
19:55:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-19-2020
19:53:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-13-2020
12:07:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/12/2020Initial Entry
Aug-19-2020
19:55:07ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812535
Page 213 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-19-2020
19:53:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/19/2020Initial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812536
Page 214 of 214
***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: 11501022 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-23-2020
00:18:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Shelly
SendersData Entry:
Click Here to EnableInitial Entry
090177e196ae2f8b\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812537