125742 S1 M5 CRF c4591001 1150 11501037

Document text

Page 1 of 168
***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: 11501037 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
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812538
Page 2 of 168
***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: 11501037 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/24/2020
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812539
Page 3 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11501037]
2.Birth Date: /1979
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812540
Page 4 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812541
Page 5 of 168
***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: 11501037 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
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812542
Page 6 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812543
Page 7 of 168
***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: 11501037 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:[Egg Allergy]
Start Date: 1979
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Irritable Bowel Syndrome]
Start Date: UNK/UNK/2014
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Heartburn]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Penicillin Allergy]
Start Date: UNK/UNK/1979
Ongoing: YES
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812544
Page 8 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sulfa Allergy]
Start Date: UNK/UNK/1979
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tuna Allergy]
Start Date: UNK/UNK/2007
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lamb Meat Allergy]
Start Date: UNK/UNK/2007
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cantelope Allergy]
Start Date: UNK/UNK/2007
Ongoing: YES
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812545
Page 9 of 168
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [152.8]
3.Unit: LB
4.Height: [58.0]
5.Unit: in
6.Body Mass Index: [31.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812546
Page 10 of 168
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/24/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812547
Page 11 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [63901]
3.Randomization Group: [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812548
Page 12 of 168
***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: 11501037 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/24/2020
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 [BN6CVN]
5.bSample ID [BN6CVP]
5.cSample ID [BN6CVR]
5.dSample ID [BL9RJV]
5.eSample ID [BL9RJW]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812549
Page 13 of 168
***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: 11501037 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/24/2020
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 [BN6CVM]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812550
Page 14 of 168
***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: 11501037 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/24/2020 18:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812551
Page 15 of 168
***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: 11501037 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
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812552
Page 16 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812553
Page 17 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812554
Page 18 of 168
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/14/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812555
Page 19 of 168
***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: 11501037 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/14/2020
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 [BN6D4G]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812556
Page 20 of 168
***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: 11501037 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/14/2020 17:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812557
Page 21 of 168
***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: 11501037 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
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812558
Page 22 of 168
***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: 11501037 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 [BN6D7T]
5.bSample ID [BL9RSF]
5.cSample ID [BL9RSG]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812559
Page 23 of 168
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 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
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812560
Page 24 of 168
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 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:
Mar/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 [BTZY0H]
5.bSample ID [BS2D1F]
5.cSample ID [BS2D1G]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812561
Page 25 of 168
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L 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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812562
Page 26 of 168
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: 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: 11501037 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 [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812563
Page 27 of 168
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L 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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812564
Page 28 of 168
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: 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: 11501037 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 [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812565
Page 29 of 168
***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: 11501037 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:
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812566
Page 30 of 168
***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: 11501037 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: [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812567
Page 31 of 168
***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: 11501037 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 [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812568
Page 32 of 168
***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: 11501037 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 [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812569
Page 33 of 168
***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: 11501037 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?
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812570
Page 34 of 168
***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: 11501037 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:
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812571
Page 35 of 168
***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: 11501037 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:
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812572
Page 36 of 168
***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: 11501037 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 [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812573
Page 37 of 168
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit 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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812574
Page 38 of 168
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812575
Page 39 of 168
***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: 11501037 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: [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812576
Page 40 of 168
***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: 11501037 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: [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812577
Page 41 of 168
***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: 11501037 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:
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812578
Page 42 of 168
***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: 11501037 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 [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812579
Page 43 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Arm soreness (injectio
n L site arm) Aug/24/2020
22:00 NO
End Date Time:
Aug/25/2020 UNK
:UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  Pain at injection site  Sep/15/2020
UNK:UNK NO
End Date Time:
Sep/16/2020 UNK:
UNK
 Repeating
Pages
 3.ADVERSE
EVENT 3  Nausea  Sep/15/2020
UNK:UNK NO
End Date Time:
Sep/16/2020 UNK:
UNK
 Repeating
Pages
 4.ADVERSE
EVENT 4  Swollen lymph nodes
under left armpit Sep/18/2020
UNK:UNK NO
End Date Time:
Dec/1/2020 UNK:
UNK
 Repeating
Pages
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812580
Page 44 of 168
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 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)[Arm soreness (injection L site arm)]
4.Start Date Time: Aug/24/2020 22:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/25/2020 UNK:UNK
6.Toxicity Grade: 2
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
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812581
Page 45 of 168
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.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
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[ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812582
Page 46 of 168
***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: 11501037 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: Sep/15/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/16/2020 UNK:UNK
6.Toxicity Grade: 1
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
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812583
Page 47 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.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
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[ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812584
Page 48 of 168
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 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)[Nausea]
4.Start Date Time: Sep/15/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/16/2020 UNK:UNK
6.Toxicity Grade: 1
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
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812585
Page 49 of 168
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.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
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[ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812586
Page 50 of 168
***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: 11501037 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)[Swollen lymph nodes under left armpit]
4.Start Date Time: Sep/18/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/1/2020 UNK:UNK
6.Toxicity Grade: 1
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
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812587
Page 51 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.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
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812588
Page 52 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categ
oryMedication
ErrorStart D
ateIs the medication error St
ill OngoingStudy Medication Err
ors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812589
Page 53 of 168
***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: 11501037 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[ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812590
Page 54 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812591
Page 55 of 168
***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: 11501037 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: //
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812592
Page 56 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812593
Page 57 of 168
***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: 11501037 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?
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812594
Page 58 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Catego
ryTreatment Ident
ifierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812595
Page 59 of 168
***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: 11501037 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?
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812596
Page 60 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812597
Page 61 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812598
Page 62 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812599
Page 63 of 168
***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: 11501037 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:
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812600
Page 64 of 168
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812601
Page 65 of 168
***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: 11501037 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?
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812602
Page 66 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812603
Page 67 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812604
Page 68 of 168
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812605
Page 69 of 168
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812606
Page 70 of 168
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11501037 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 [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812607
Page 71 of 168
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11501037 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 [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812608
Page 72 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812609
Page 73 of 168
***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: 11501037 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812610
Page 74 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/29/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812611
Page 75 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812612
Page 76 of 168
***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: 11501037 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: [ ]
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812613
Page 77 of 168
***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: 11501037 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
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812614
Page 78 of 168
***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: 11501037 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
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812615
Page 79 of 168
***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: 11501037 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 21:01:23 (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.
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812616
Page 80 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormAug-24-2020 19:01:08 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0812617
Page 81 of 168
***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: 11501037 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 21:01:23 (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-11-2021 14:59:06 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shelly
Senders Approved Jan-23-2021 20:21:23 (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.
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812618
Page 82 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
 N/A Dec-17-2020 16:28:55 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Shelly
Senders Approved Oct-28-2020 16:51:47 (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.
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812619
Page 83 of 168
***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: 11501037 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-24-2020
18:40:51
(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-24-2020
18:40:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812620
Page 84 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-24-2020
19:00:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Ob
tained
Aug/24/2020Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812621
Page 85 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020
18:40:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11501037Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020
18:40:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1979Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-24-2020
19:00:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-24-2020
19:00:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LAT
INO(A) OR OF SPANISH
ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812622
Page 86 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-24-2020
19:00:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812623
Page 87 of 168
***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: 11501037 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-24-2020
19:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812624
Page 88 of 168
***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: 11501037 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-24-2020
19:01:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-24-2020
19:01:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-24-2020
19:01:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812625
Page 89 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020
19:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Egg Alle
rgy
Start Date: /19
79
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-24-2020
19:02:02
(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-24-2020
19:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Egg AllergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-24-2020
19:02:02ACV0PFEINFP6000  Data Entry:
/1979Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812626
Page 90 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)
1.a Ongoing:
Date Location User Value Reason
Aug-24-2020
19:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-24-2020
19:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Irritable Bow
el Syndrome
Start Date: UNK/UNK/2
014
Ongoing: YESInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812627
Page 91 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Line/MH Number:
Date Location User Value Reason
Aug-24-2020
19:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
19:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Irritable Bowel SyndromeInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-24-2020
19:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-24-2020
19:02:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae2f8a\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-2021-5683-0812628
Page 92 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-24-2020
19:02:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histo
ry Term:Heartburn
Start Date: UNK/UN
K/2000
Ongoing: YESInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812629
Page 93 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.c Line/MH Number:
Date Location User Value Reason
Aug-24-2020
19:02:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
19:02:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HeartburnInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-24-2020
19:02:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-24-2020
19:02:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae2f8a\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-2021-5683-0812630
Page 94 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-24-2020
19:03:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histo
ry Term:Penicillin
Allergy
Start Date: UNK/UNK
/1979
Ongoing: YESInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812631
Page 95 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d Line/MH Number:
Date Location User Value Reason
Aug-24-2020
19:03:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
19:03:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Penicillin AllergyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-24-2020
19:03:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1979Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-24-2020
19:03:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
090177e196ae2f8a\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-2021-5683-0812632
Page 96 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-24-2020
19:03:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histo
ry Term:Sulfa Aller
gy
Start Date: UNK/UN
K/1979
Ongoing: YESInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812633
Page 97 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.e Line/MH Number:
Date Location User Value Reason
Aug-24-2020
19:03:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
19:03:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sulfa AllergyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-24-2020
19:03:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1979Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-24-2020
19:03:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
090177e196ae2f8a\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-2021-5683-0812634
Page 98 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-24-2020
19:04:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histo
ry Term:Tuna Aller
gy
Start Date: UNK/UN
K/2007
Ongoing: YESInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812635
Page 99 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f Line/MH Number:
Date Location User Value Reason
Aug-24-2020
19:04:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
19:04:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Tuna AllergyInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-24-2020
19:04:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-24-2020
19:04:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
090177e196ae2f8a\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-2021-5683-0812636
Page 100 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-25-2020
07:34:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Line/MH N
umber:7
Medical Hi
story Term
:Lamb Me
at Allergy
Start Date: UNK/UN
K/2007
Ongoing: YESTranscription
Error
Aug-24-2020
19:04:27
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical His
tory Term:Lamb Al
lergy
Start Date: UNK/U
NK/2007
Ongoing: YESInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812637
Page 101 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.g Line/MH Number:
Date Location User Value Reason
Aug-24-2020
19:04:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Aug-25-2020
09:58:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Aug-25-2020
07:34:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription
Error
Aug-25-2020
07:34:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Lamb
Meat
Allerg
yTranscription
Error
Aug-25-2020
01:46:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Op
enedClarify
LAMB
ALLERGY
as
follows...Are
you
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812638
Page 102 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
reporting
LAMB
WOOL
ALLERGY?
LAMB
MEAT
ALLERGY?
Other? If so,
edit.
Otherwise
clarify.
Thank you.
Aug-24-2020
19:04:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Lamb
Allerg
yInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-24-2020
19:04:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-24-2020
19:04:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
090177e196ae2f8a\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-2021-5683-0812639
Page 103 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-24-2020
19:05:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Histo
ry Term:Cantelope
Allergy
Start Date: UNK/UNK
/2007
Ongoing: YESInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812640
Page 104 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.h Line/MH Number:
Date Location User Value Reason
Aug-24-2020
19:05:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020
19:05:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cantelope AllergyInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-24-2020
19:05:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-24-2020
19:05:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f8a\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-2021-5683-0812641
Page 105 of 168
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Aug-24-2020
19:06:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-24-2020
19:06:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
152.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-24-2020
19:06:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-24-2020
19:06:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
58.0Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae2f8a\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-2021-5683-0812642
Page 106 of 168
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-24-2020
19:06:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-24-2020
19:06:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.9Initial Entry
7.a
Date Location User Value Reason
Aug-24-2020
19:06:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identi
fier::1
Temperature: 99.1
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-24-2020
19:06:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
090177e196ae2f8a\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-2021-5683-0812643
Page 107 of 168
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - 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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-24-2020
19:06:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
99.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-24-2020
19:06:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-24-2020
19:06:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f8a\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-2021-5683-0812644
Page 108 of 168
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-24-2020
19:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-24-2020
19:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-24-2020
19:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-24-2020
19:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812645
Page 109 of 168
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Aug-24-2020
19:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-24-2020
19:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-De
fined Identi
fier:113
Test:: Choriogonado
tropin Beta_P
X113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-24-2020
19:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-24-2020
19:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_
PX113Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812646
Page 110 of 168
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
6.a Result:
Date Location User Value Reason
Aug-24-2020
19:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812647
Page 111 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-24-2020
19:06:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-24-2020
19:06:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
63901Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812648
Page 112 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020
19:06:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020
19:06:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020
19:07:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-24-2020
19:06:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-24-2020
19:06:56ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812649
Page 113 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)Date of Collection:
Aug/24/2020
5.a
Date Location User Value Reason
Aug-24-2020
19:07:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6CVNInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020
19:07:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN6CVNInitial Entry
5.b
Date Location User Value Reason
Aug-24-2020
19:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6CVPInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-24-2020
19:07:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN6CVPInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812650
Page 114 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.c
Date Location User Value Reason
Aug-24-2020
19:07:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6CVRInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-24-2020
19:07:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN6CVRInitial Entry
5.d
Date Location User Value Reason
Aug-24-2020
19:07:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9RJVInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-24-2020
19:07:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BL9RJVInitial Entry
5.e
Date Location User Value Reason
090177e196ae2f8a\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-2021-5683-0812651
Page 115 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-24-2020
19:07:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9RJWInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-24-2020
19:07:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BL9RJWInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812652
Page 116 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020
19:08:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020
19:08:38
(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-24-2020
19:08:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-24-2020
19:08:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Aug-24-2020
19:08:38ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812653
Page 117 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)Date of Collection:
Aug/24/2020
5.a
Date Location User Value Reason
Aug-24-2020
19:08:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6CVMInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-24-2020
19:08:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN6CVMInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812654
Page 118 of 168
***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: 11501037 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-24-2020
19:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-24-2020
19:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020
19:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-24-2020
19:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020 18:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812655
Page 119 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Aug-24-2020
19:09:26
(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-24-2020
19:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-24-2020
19:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-24-2020
19:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Aug-24-2020
19:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812656
Page 120 of 168
***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: 11501037 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-24-2020
19:09:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLLE
CTED FOR THIS SUBJE
CTInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812657
Page 121 of 168
***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: 11501037 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-15-2020
15:37:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812658
Page 122 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020
15:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2.a
Date Location User Value Reason
Sep-15-2020
15:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 98.2
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-15-2020
15:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-15-2020
15:38:03
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
98.2Initial Entry
090177e196ae2f8a\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-2021-5683-0812659
Page 123 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
2.a Unit:
Date Location User Value Reason
Sep-15-2020
15:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-15-2020
15:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812660
Page 124 of 168
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-15-2020 15:38:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-15-2020 15:38:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-15-2020
15:38:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-15-2020 15:38:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-15-2020 15:38:25 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812661
Page 125 of 168
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) URINE
6.a
Date Location User Value Reason
Sep-15-2020 15:38:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-De
fined Identi
fier:113
Test:: Choriogonado
tropin Beta_P
X113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-15-2020 15:38:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-15-2020
15:38:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-15-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812662
Page 126 of 168
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
15:38:25
(UTC-05:00) Eastern
Time (US & Canada)NEGATIVE
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812663
Page 127 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 15:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 15:39:19
(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-15-2020
15:40:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-15-2020
15:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-15-2020
15:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812664
Page 128 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep/14/2020
5.a
Date Location User Value Reason
Sep-15-2020
15:40:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6D4GInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-15-2020
15:40:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN6D4GInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812665
Page 129 of 168
***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: 11501037 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-15-2020
15:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020 15:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020 15:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-15-2020
15:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020 17:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020 15:39:02 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812666
Page 130 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) DELTOID MUSCLE
6. Body Side:
Date Location User Value Reason
Sep-15-2020
15:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-15-2020 15:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-15-2020 15:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-15-2020
15:39:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812667
Page 131 of 168
***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: 11501037 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-12-2020
10:04:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812668
Page 132 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 10:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 10:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020
10:04:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-12-2020
10:04:47
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-12-2020
10:04:47
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812669
Page 133 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US &
Canada) Oct/12/2020
5.a
Date Location User Value Reason
Oct-12-2020
10:04:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6D7TInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-12-2020
10:04:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BN6D7TInitial Entry
5.b
Date Location User Value Reason
Oct-12-2020
10:05:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9RSFInitial Entry
090177e196ae2f8a\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-2021-5683-0812670
Page 134 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.b Sample ID
Date Location User Value Reason
Oct-12-2020
10:05:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BL9RSFInitial Entry
5.c
Date Location User Value Reason
Oct-12-2020
10:05:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9RSGInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-12-2020
10:05:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BL9RSGInitial Entry
090177e196ae2f8a\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-2021-5683-0812671
Page 135 of 168
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 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
10:16:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Mar/8/2021Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812672
Page 136 of 168
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-08-2021
10:16:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-08-2021
10:16:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-08-2021
10:16:47
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-08-2021
10:16:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812673
Page 137 of 168
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-08-2021
10:16:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/8/2021Initial Entry
5.a
Date Location User Value Reason
Mar-08-2021
10:16:47
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BTZY0HInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-08-2021
10:16:47
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BTZY0HInitial Entry
5.b
Date Location User Value Reason
Mar-08-2021
10:17:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS2D1FInitial Entry
090177e196ae2f8a\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-2021-5683-0812674
Page 138 of 168
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.b Sample ID
Date Location User Value Reason
Mar-08-2021
10:17:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BS2D1FInitial Entry
5.c
Date Location User Value Reason
Mar-08-2021
10:17:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS2D1GInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-08-2021
10:17:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
BS2D1GInitial Entry
090177e196ae2f8a\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-2021-5683-0812675
Page 139 of 168
***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: 11501037 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-12-2020
10:07:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020 10:07:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020
10:07:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812676
Page 140 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Sep-15-2020 15:43:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812677
Page 141 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Oct-12-2020
10:07:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812678
Page 142 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Oct-12-2020
10:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812679
Page 143 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Oct-12-2020
10:10:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812680
Page 144 of 168
***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, Locked, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Sep-15-2020 15:43:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-15-2020 15:43:26
(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
Sep-15-2020
15:43:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Arm soreness (injection L s
ite arm)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-15-2020
15:43:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020 22:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812681
Page 145 of 168
***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, Locked, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-15-2020
15:43:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/25/2020 UNK:UN
KInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-15-2020
15:43:26
(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 medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-15-2020
15:43:26
(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
Sep-15-2020
15:43:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8a\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-2021-5683-0812682
Page 146 of 168
***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, Locked, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-15-2020
15:43:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-15-2020
15:43:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-15-2020
15:43:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-15-2020
15:43:26
(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
090177e196ae2f8a\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-2021-5683-0812683
Page 147 of 168
***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, Locked, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Sep-15-2020
15:43:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-15-2020
15:43:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812684
Page 148 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020 10:07:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-12-2020 10:07:53
(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
Dec-18-2020
07:49:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response
satisfies query
Dec-17-2020
16:28:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Dec-17-2020
16:28:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Pain at injection siteTranscription
Error
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812685
Page 149 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-17-2020
10:49:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY:
Please clarify if
the event term
reported is
intended to report
a musculokeletal
issue/ general
myalgia of the
arm, or an
injection site
pain. If the latter,
please consider
reviewing term
for coding
Oct-12-2020
10:07:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Arm Soreness (Left ar
m)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-12-2020
10:07:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-12-2020
10:07:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/16/2020 UNK:UInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812686
Page 150 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
NK
6. Toxicity Grade:
Date Location User Value Reason
Oct-12-2020
10:07:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
1Initial 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).
Date Location User Value Reason
Oct-12-2020
10:07:53
(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
Oct-12-2020
10:07:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae2f8a\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-2021-5683-0812687
Page 151 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Oct-12-2020
10:07:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-12-2020
10:07:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-12-2020
10:07:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-12-2020
10:07:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae2f8a\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-2021-5683-0812688
Page 152 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Oct-12-2020
10:07:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-12-2020
10:07:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812689
Page 153 of 168
***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, Locked, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020 10:08:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-12-2020 10:08:37
(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
Oct-12-2020
10:08:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NauseaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-12-2020
10:08:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812690
Page 154 of 168
***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, Locked, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Oct-12-2020
10:08:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/16/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-12-2020
10:08:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
1Initial 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).
Date Location User Value Reason
Oct-12-2020
10:08:37
(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
090177e196ae2f8a\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-2021-5683-0812691
Page 155 of 168
***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, Locked, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-12-2020
10:08:37
(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
Oct-12-2020
10:08:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-12-2020
10:08:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-12-2020
10:08:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae2f8a\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-2021-5683-0812692
Page 156 of 168
***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, Locked, Frozen
Site No: 1150 Site Name: (1150) Senders Pediatrics
Subject No: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-12-2020
10:08:37
(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
Oct-12-2020
10:08:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-12-2020
10:08:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8a\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-2021-5683-0812693
Page 157 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020 10:10:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-12-2020 10:10:34
(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
Oct-12-2020
10:10:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Swollen lymph nodes un
der left armpitInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-12-2020
10:10:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812694
Page 158 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Mar-08-2021
10:17:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/1/2020 UNK:
UNKTranscription Error
Dec-16-2020
11:52:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Closed Response satisfies
query
Dec-15-2020
16:09:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered ongoing at this
time
Dec-15-2020
08:39:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Reissued:Op
enedCLINQUERY:
Lymphadenopathy
is reported to
remain ongoing for
3mths. Please
confirm this event
has been reviewed
Dec-14-2020
15:27:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered Original value is
correct
Dec-11-2020
10:38:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Opened CLINQUERY:
Please review if
event remains
ongoing. Else,
report end date and
update event
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812695
Page 159 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
outcome status
Nov-09-2020
11:32:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Closed Response satisfies
query
Nov-09-2020
11:11:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Nov-09-2020
10:45:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Opened Clin: Please
confirm if this AE
is still ongoing
Oct-12-2020
10:10:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-12-2020
10:10:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812696
Page 160 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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).
Date Location User Value Reason
Oct-12-2020
10:10:34
(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
Oct-12-2020
10:10:34
(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
Oct-12-2020
10:10:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study t
reatment(s), this event i
s due to:
OTHER
If Other, specify:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae2f8a\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-2021-5683-0812697
Page 161 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date Location User Value Reason
Oct-12-2020
10:10:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-12-2020
10:10:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-12-2020
10:10:34
(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
10:18:11
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Mar-08-2021
10:18:11
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOL
VEDTranscription
Error
090177e196ae2f8a\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-2021-5683-0812698
Page 162 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Eastern Time (US &
Canada)
Mar-08-2021
10:17:53
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Swollen
lymph nodes
under left armpit:
Response to
"What was the
outcome of this
adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Oct-12-2020
10:10:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/N
OT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-12-2020
10:10:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812699
Page 163 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-11-2021
14:59:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812700
Page 164 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-15-2021
15:24:29
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-12-2021
01:03:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing in
the DISP visit.
Please complete
this date.
Feb-11-2021
14:59:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing in
the DISP visit.
Please complete
this date.
Feb-11-2021
14:59:14
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000  Data Entry:
Participant is willing to
return for Vaccination 3
Participant is:Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0812701
Page 165 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Canada)
eligible and NOT co
nfirmed to have recei
ved only placebo at V
accination 1/2
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812702
Page 166 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-15-2021
15:24:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-15-2021
15:24:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY F
OR ADDITIONAL VACC
INATIONInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0812703
Page 167 of 168
***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: 11501037 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-12-2020 10:07:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-24-2020
19:06:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZE
DInitial Entry
Aug-24-2020
19:01:19
(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-12-2020 10:07:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/12/2020Initial Entry
Aug-24-2020
19:06:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/24/2020Initial Entry
Aug-24-2020
19:01:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/24/2020Initial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0812704
Page 168 of 168
***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: 11501037 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
00:22:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Shelly
SendersData Entry:
Click Here to EnableInitial Entry
090177e196ae2f8a\Final\Final On: 01-Apr-2021 03:46 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0812705