125742 S1 M5 CRF c4591001 1016 10161289

Document text

Page 1 of 379
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786507
Page 2 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/18/2020
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786508
Page 3 of 379
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10161289]
2.Birth Date: /2002
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
WHITE
6.Racial Designation:
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786509
Page 4 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786510
Page 5 of 379
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786511
Page 6 of 379
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786512
Page 7 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[asthma]
Start Date: Jun/30/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: May/UNK/2008
Ongoing: YES
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786513
Page 8 of 379
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786514
Page 9 of 379
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
2.Weight: [132.4]
3.Unit: LB
4.Height: [64.4]
5.Unit: in
6.Body Mass Index: [22.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786515
Page 10 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/18/2020
2.Randomization Number: [93329]
3.Randomization Group: [ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786516
Page 11 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8ZP6]
5.bSample ID [BNWZ7Z]
5.cSample ID [BLCRZN]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786517
Page 12 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPBX5H]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786518
Page 13 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/18/2020 10:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786519
Page 14 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786520
Page 15 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786521
Page 16 of 379
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786522
Page 17 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
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 [BPBX8X]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786523
Page 18 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/7/2020 09:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786524
Page 19 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786525
Page 20 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/6/2020
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 [BR2MNZ]
5.bSample ID [BS8BG2]
5.cSample ID [BSJK97]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786526
Page 21 of 379
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786527
Page 22 of 379
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786528
Page 23 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786529
Page 24 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786530
Page 25 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786531
Page 26 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786532
Page 27 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786533
Page 28 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/9/2020
2.Date of First Symptom Started: Oct/7/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/11/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? YES
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4 hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786534
Page 29 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [chest tightness]
5.bSymptoms - Other Text: [runny nose]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786535
Page 30 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Oct/9/202
0 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786536
Page 31 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/9/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [BDVeritorSystemRapidDetectionofSARS-COV -2CLIA-cert]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786537
Page 32 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[no self swab obtained]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786538
Page 33 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/9/2020
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 [BPBX95]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786539
Page 34 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786540
Page 35 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786541
Page 36 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntTreatme
ntStart Da
teForm Instance
 1.Not Done  Not Done  Not Done
 Not Done
 Not Done
 Repeating
Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786542
Page 37 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786543
Page 38 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786544
Page 39 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786545
Page 40 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Done Comments
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786546
Page 41 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Done  Not Done
 Not Done  Not Done Sponsor-Defined
IdentifierTest:Result
:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786547
Page 42 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786548
Page 43 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786549
Page 44 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Bilirubin_PX21
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786550
Page 45 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5 fSponsor ID: Not Done
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Creatinine_PX48
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786551
Page 46 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done
 Sponsor-Define
d IdentifierTest:Resul
t:
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one 
Not Done  Not D
one Not D
one Repeating
Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786552
Page 47 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Done Comments
2.Laboratory Name and Address Not Done
[ ]Comments
3.Collection Date: Not Done
//Comments
4.Specimen Type: Not Done Comments
Lab Result
5.aSponsor ID: Not Done
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786553
Page 48 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.bSponsor ID: Not Done
[ ]Comments
Test: Hematocrit_PX2
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Done
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786554
Page 49 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.dSponsor ID: Not Done
[ ]Comments
Test: Platelets_PX5
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Done
[ ]Comments
Test: Leukocytes_PX7
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786555
Page 50 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5 fSponsor ID: Not Done
[ ]Comments
Test: Neutrophils_PX608
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Done
[ ]Comments
Test: Eosinophils_PX609
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786556
Page 51 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5 hSponsor ID: Not Done
[ ]Comments
Test: Monocytes_PX612
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Done
[ ]Comments
Test: Basophils_PX610
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786557
Page 52 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.jSponsor ID: Not Done
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Done
[ ]Comments
Not Done: Not Done Comments
LNMT Not Done
Low
[ ]
High
[ ]
UnitComments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786558
Page 53 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Systolic: Diastolic:
Not Done  Not Done  Not Done Repeating Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786559
Page 54 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
Systolic: Not Done
[ ]Comments
Diastolic: Not Done
[ ]Comments
Respiratory Rate in
respirations/minute:Not Done
[ ]Comments
Heart Rate in beats/minute: Not Done
[ ]Comments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786560
Page 55 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Date: Vital Signs Details Form Instance
 1.Not Done Record Identifier: Oxygen Saturation
Not Done  Not Done Repeating Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786561
Page 56 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Done
//Comments
Vital Signs Details
2.aRecord Identifier: Not Done
1
SPO2 Pulse Oximetry % Not Done
[ ]Comments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786562
Page 57 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
 1.Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786563
Page 58 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Done
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Done
[ ]Comments
3.FiO2 (Fraction of Inhaled
Oxygen):Not Done
[ ]Comments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786564
Page 59 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786565
Page 60 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Done
[ ]Comments
2.Category: Not Done Comments
3.Concomitant Medications
Pre-specified:Not Done Comments
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).Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786566
Page 61 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786567
Page 62 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Done
//Comments
2.Location of Assessment: Not Done Comments
3.Type of Imaging Exam: Not Done Comments
4.Assessment: Not Done Comments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786568
Page 63 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/09/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786569
Page 64 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/09/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/9/2020
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 [BR2MP4]
5.bSample ID [BSJK9C]
5.cSample ID [BS8BG8]
5.dSample ID [BS8BG7]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786570
Page 65 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786571
Page 66 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786572
Page 67 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786573
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***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786574
Page 69 of 379
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  fever  Sep/18/2020 20:3
0 NO
End Date Time:
Sep/20/2020 11:30
 Repeating
Pages
 2.ADVERSE E
VENT 2  chills  Sep/18/2020 20:3
0 NO
End Date Time:
Sep/20/2020 11:30
 Repeating
Pages
 3.ADVERSE E
VENT 3  facial fractures  Oct/31/2020 UN
K:UNK YES  Repeating
Pages
 4.ADVERSE E
VENT 4  concussion  Oct/31/2020 UN
K:UNK YES  Repeating
Pages
 5.ADVERSE E
VENT 5  motor vehicle ac
cident Oct/31/2020 UN
K:UNK NO
End Date Time:
Oct/31/2020 UNK:UN
K
 Repeating
Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786575
Page 70 of 379
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fever]
4.Start Date Time: Sep/18/2020 20:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/20/2020 11:30
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
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
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786576
Page 71 of 379
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786577
Page 72 of 379
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[chills]
4.Start Date Time: Sep/18/2020 20:30
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/20/2020 11:30
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
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
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786578
Page 73 of 379
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786579
Page 74 of 379
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[facial fractures]
4.Start Date Time: Oct/31/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
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Page 75 of 379
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[motor vehicle accident]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020426020]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786581
Page 76 of 379
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[concussion]
4.Start Date Time: Oct/31/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
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
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
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786582
Page 77 of 379
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[motor vehicle accident]
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?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786583
Page 78 of 379
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[motor vehicle accident]
4.Start Date Time: Oct/31/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/31/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786584
Page 79 of 379
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[motor vehicle accident]
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[ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786585
Page 80 of 379
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786586
Page 81 of 379
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786587
Page 82 of 379
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786588
Page 83 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786589
Page 84 of 379
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786590
Page 85 of 379
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786591
Page 86 of 379
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786592
Page 87 of 379
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786593
Page 88 of 379
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786594
Page 89 of 379
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786595
Page 90 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/6/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786596
Page 91 of 379
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786597
Page 92 of 379
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786598
Page 93 of 379
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786599
Page 94 of 379
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786600
Page 95 of 379
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786601
Page 96 of 379
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786602
Page 97 of 379
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/29/2021
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786603
Page 98 of 379
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
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 [BR7LJB]
5.bSample ID [BSCK1H]
5.cSample ID [BSCKHN]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786604
Page 99 of 379
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/29/2021
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 [BR7ZJT]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786605
Page 100 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786606
Page 101 of 379
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/12/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK2
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786607
Page 102 of 379
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 -
Unscheduled Visit on Feb/12/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Feb/12/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA09649]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786608
Page 103 of 379
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/25/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK4
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786609
Page 104 of 379
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 2 -
Unscheduled Visit on Feb/25/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA09629]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786610
Page 105 of 379
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/11/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/11/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK6
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786611
Page 106 of 379
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 3 -
Unscheduled Visit on Mar/11/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Mar/11/2021
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 [AA03677]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786612
Page 107 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786613
Page 108 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786614
Page 109 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/24/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786615
Page 110 of 379
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786616
Page 111 of 379
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786617
Page 112 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/6/2020
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786618
Page 113 of 379
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786619
Page 114 of 379
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786620
Page 115 of 379
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-18-2020 12:07:23 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786621
Page 116 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-09-2020 15:49:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786622
Page 117 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-09-2020 15:49:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786623
Page 118 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-09-2020 15:49:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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(b) (4)
FDA-CBER-2021-5683-0786624
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3Oct-09-2020 15:49:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0786625
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
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ItemDate User Comment
4Oct-09-2020 15:49:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786626
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
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ItemDate User Comment
5Oct-09-2020 15:49:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786627
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ItemDate User Comment
6Oct-09-2020 15:49:07 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
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FDA-CBER-2021-5683-0786628
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FormOct-09-2020 15:49:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0786629
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Subject No: 10161289 Subject Initials: ---
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ItemDate User Comment
1Oct-09-2020 15:49:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786630
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
2Oct-09-2020 15:49:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786631
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
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ItemDate User Comment
3Oct-09-2020 15:49:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786632
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
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ItemDate User Comment
4Oct-09-2020 15:49:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786633
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
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FormOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
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1Oct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
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ItemDate User Comment
2Oct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
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ItemDate User Comment
3Oct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786637
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
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ItemDate User Comment
4Oct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0786638
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
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ItemDate User Comment
5.aOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0786639
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
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ItemDate User Comment
5.aOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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(b) (4)
FDA-CBER-2021-5683-0786640
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
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ItemDate User Comment
5.aOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
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ItemDate User Comment
5.aOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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FDA-CBER-2021-5683-0786642
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Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
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ItemDate User Comment
5.bOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786643
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
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ItemDate User Comment
5.bOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
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ItemDate User Comment
5.bOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
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ItemDate User Comment
5.bOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
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ItemDate User Comment
5.cOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
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ItemDate User Comment
5.cOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
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ItemDate User Comment
5.cOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
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Back to Form
ItemDate User Comment
5.cOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.dOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.dOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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FDA-CBER-2021-5683-0786654
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
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Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.eOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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FDA-CBER-2021-5683-0786655
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: LOCAL LABORATORY DATA - REPEATING
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Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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ItemDate User Comment
5.eOct-09-2020 15:49:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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FDA-CBER-2021-5683-0786656
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled
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2Oct-09-2020 15:49:51 (UTC-05:00) Eastern
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3Oct-09-2020 15:49:51 (UTC-05:00) Eastern
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Time (US & Canada)Not Done
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5.eOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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5.eOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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5.fOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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5.fOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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5.fOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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5.gOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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5.gOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
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5.gOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
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5.gOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
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5.hOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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5.hOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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5.hOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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5.hOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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5.iOct-09-2020 15:49:51 (UTC-05:00) Eastern
Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Time (US & Canada)Not Done
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Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-09-2020 15:50:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786722
Page 217 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-09-2020 15:50:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786723
Page 218 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-09-2020 15:50:21 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786724
Page 219 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-09-2020 15:50:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786725
Page 220 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-09-2020 15:50:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786726
Page 221 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-09-2020 15:50:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786727
Page 222 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-09-2020 15:50:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786728
Page 223 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-09-2020 15:50:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786729
Page 224 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-09-2020 15:50:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786730
Page 225 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-09-2020 15:50:30 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786731
Page 226 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-09-2020 15:50:42 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786732
Page 227 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-09-2020 15:50:42 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786733
Page 228 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-09-2020 15:50:42 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786734
Page 229 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-09-2020 15:50:42 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786735
Page 230 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-09-2020 15:50:42 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786736
Page 231 of 379
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Jan-29-2021 11:19:34 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-13-2020 13:27:04 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786737
Page 232 of 379
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-18-2020 12:06:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-18-2020 12:06:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786738
Page 233 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-18-2020 12:06:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Sep/18/2020Initial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786739
Page 234 of 379
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-18-2020 12:05:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10161289Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-18-2020 12:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/2002Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-18-2020 12:07:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-18-2020 12:07:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-18-2020 12:07:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRICAN AME
RICAN
WHITEInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786740
Page 235 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020 12:07:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786741
Page 236 of 379
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-18-2020 12:07:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-18-2020 12:07:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-18-2020 12:07:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786742
Page 237 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-18-2020 12:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:asthma
Start Date: Jun/30/20
10
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-18-2020 12:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 12:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
asthmaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-18-2020 12:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/30/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-18-2020 12:08:23
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786743
Page 238 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
1.b
Date Location User Value Reason
Sep-18-2020 12:08:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:seasonal alle
rgies
Start Date: May/UNK/2
008
Ongoing: YESInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0786744
Page 239 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-18-2020 12:08:52
(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
Sep-18-2020 12:08:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergiesInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-18-2020 12:08:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
May/UNK/2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-18-2020 12:08:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0786745
Page 240 of 379
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-18-2020 12:09:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to
be HIV POSITIVEInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786746
Page 241 of 379
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 12:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-18-2020 12:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
132.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-18-2020 12:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-18-2020 12:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
64.4Initial Entry
5. Unit:
Date Location User Value Reason
Sep-18-2020 12:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0786747
Page 242 of 379
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020 12:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22.4Initial Entry
7.a
Date Location User Value Reason
Sep-18-2020 12:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 98.4
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 12:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-18-2020 12:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-18-2020 12:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0786748
Page 243 of 379
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020 12:09:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786749
Page 244 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-18-2020 12:10:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-18-2020 12:10:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
93329Initial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786750
Page 245 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 13:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 13:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020 13:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 13:26:03
(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-18-2020 13:26:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786751
Page 246 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020 13:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8ZP6Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 13:26:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8ZP6Initial Entry
5.b
Date Location User Value Reason
Sep-18-2020 13:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWZ7ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-18-2020 13:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNWZ7ZInitial Entry
5.c
Date Location User Value Reason
Sep-18-2020 13:26:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLCRZNInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-18-2020 13:26:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLCRZNInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786752
Page 247 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 13:26:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 13:26:53
(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-18-2020 13:27:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 13:26:53
(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-18-2020 13:26:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786753
Page 248 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020 13:27:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPBX5HInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 13:27:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPBX5HInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786754
Page 249 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020 12:10:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 12:10:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 12:10:31
(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-18-2020 12:10:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020 10:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 12:10:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786755
Page 250 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020 12:10:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020 12:10:31
(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-18-2020 12:10:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-18-2020 12:10:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786756
Page 251 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-18-2020 12:10:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786757
Page 252 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 10:42:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786758
Page 253 of 379
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-07-2020 10:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2.a
Date Location User Value Reason
Oct-07-2020 10:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 98.4
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-07-2020 10:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-07-2020 10:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786759
Page 254 of 379
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-07-2020 10:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-07-2020 10:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786760
Page 255 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 10:43:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 10:43:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020 10:44:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 10:43:12
(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-07-2020 10:43:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786761
Page 256 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-07-2020 10:44:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPBX8XInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020 10:44:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPBX8XInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786762
Page 257 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-07-2020 10:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-07-2020 10:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-07-2020 10:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-07-2020 10:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020 09:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-07-2020 10:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786763
Page 258 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-07-2020 10:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-07-2020 10:44:51
(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
Oct-07-2020 10:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-07-2020 10:44:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786764
Page 259 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020 11:15:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/6/2020Initial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786765
Page 260 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-06-2020 11:15:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-06-2020 11:15:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-06-2020 11:15:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-06-2020 11:15:20
(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.
Nov-06-2020 11:15:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/6/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786766
Page 261 of 379
***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: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-06-2020 11:15:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR2MNZInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-06-2020 11:15:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR2MNZInitial Entry
5.b
Date Location User Value Reason
Nov-06-2020 11:15:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS8BG2Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-06-2020 11:15:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS8BG2Initial Entry
5.c
Date Location User Value Reason
Nov-06-2020 11:15:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSJK97Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-06-2020 11:15:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSJK97Initial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786767
Page 262 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-09-2020 15:48:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-09-2020 15:45:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Oct-09-2020 15:45:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Oct-09-2020 15:45:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-09-2020 15:45:37
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786768
Page 263 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0786769
Page 264 of 379
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-09-2020 14:48:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resol
ved:
Oct/11/2020Changed
Information
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786770
Page 265 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCRE
ASED COUGH
Symptom
Present:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COU
GHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786771
Page 266 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS O
F BREATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHO
RTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786772
Page 267 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.d Symptoms:
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED MUSCLE PA
IN
Sympto
m Presen
t:YESInitial Entry
4.e Symptoms:
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUS
CLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786773
Page 268 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.f
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Presen
t:YESInitial Entry
090177e196ae3fce\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0786774
Page 269 of 379
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161289 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.g Symptoms:
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SOR
E THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Oct-09-2020 15:46:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:NOInitial Entry
4.h Symptoms:
Date Loc
…[truncated]