Document text
Page 1 of 248
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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 version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785146
Page 2 of 248
***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: 10161087 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
Aug/10/2020
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785147
Page 3 of 248
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10161087]
2.Birth Date: /1976
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785148
Page 4 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/10/2020
2.Erroneous Visit
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785149
Page 5 of 248
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785150
Page 6 of 248
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785151
Page 7 of 248
***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: 10161087 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:[hysterectomy]
Start Date: Jun/UNK/2015
Ongoing: NO
End Date:
Jun/UNK/2015
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ovarian fibroid]
Start Date: Jan/UNK/2015
Ongoing: NO
End Date:
Jun/UNK/2015
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: Apr/UNK/1994
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[migraines]
Start Date: Apr/UNK/2010
Ongoing: YES
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785152
Page 8 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[meniscus repair]
Start Date: Jul/UNK/2009
Ongoing: NO
End Date:
Jul/UNK/2009
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to flagyl]
Start Date: Apr/UNK/2002
Ongoing: YES
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785153
Page 9 of 248
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/10/2020
2.Weight: [170.1]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [24.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785154
Page 10 of 248
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/10/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785155
Page 11 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/10/2020
2.Randomization Number: [44493]
3.Randomization Group: [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785156
Page 12 of 248
***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: 10161087 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:
Aug/10/2020
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 [BM82ZG]
5.bSample ID [BM82ZH]
5.cSample ID [BM82ZJ]
5.dSample ID [BLCS9V]
5.eSample ID [BLCS9W]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785157
Page 13 of 248
***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: 10161087 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:
Aug/10/2020
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 [BM8G0R]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785158
Page 14 of 248
***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: 10161087 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: Aug/10/2020 10:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785159
Page 15 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785160
Page 16 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785161
Page 17 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
YES
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785162
Page 18 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/21/2020
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785163
Page 19 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785164
Page 20 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/31/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785165
Page 21 of 248
***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: 10161087 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:
Aug/31/2020
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 [BM8G79]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785166
Page 22 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?Not Done Comments
2.Treatment Name Not Done
[ ]Comments
3.Formulation: Not Done Comments
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location: Not Done Comments
6.Body Side: Not Done Comments
7.Route: Not Done Comments
8.Actual Dose: Not Done
[ ]Comments
9.Unit: Not Done Comments
10.Timeframe Subject Was Observed Not Done Comments
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?Not Done Comments
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785167
Page 23 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785168
Page 24 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?Not Done Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785169
Page 25 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Done Comments
3.Injection Site Location: Not Done Comments
4.Injection Site Body Side: Not Done Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Done Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Done Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Done Comments
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785170
Page 26 of 248
***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: 10161087 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/30/2020
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 [BP8ZT9]
5.bSample ID [BNWZC5]
5.cSample ID [BLCS3D]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785171
Page 27 of 248
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785172
Page 28 of 248
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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:
Feb/23/2021
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 [BRLTJJ]
5.bSample ID [BSCK5G]
5.cSample ID [BSCKLW]
5.dSample ID [BSCKLX]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785173
Page 29 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785174
Page 30 of 248
***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: 10161087 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 [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785175
Page 31 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785176
Page 32 of 248
***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: 10161087 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 [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785177
Page 33 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: 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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785178
Page 34 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/1/2021
2.Date of First Symptom Started: Jan/31/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Feb/7/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
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? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785179
Page 35 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptoms - Other
5.aSymptoms - Other Text: [headache]
5.bSymptoms - Other Text: [nasal congestion]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785180
Page 36 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
1.Feb/1/202
1 SWABBED M
ATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785181
Page 37 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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: Feb/1/2021
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: ABBOTT MOLECULAR REALTIME SARS-COV-2 ASSAY
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785182
Page 38 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: 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: 10161087 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 collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785183
Page 39 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: 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: 10161087 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:
Feb/1/2021
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 [BR7ZK6]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785184
Page 40 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
Health Care Utilization Other
2.Other Type of Practitioner Specify: [employer- ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785185
Page 41 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785186
Page 42 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785187
Page 43 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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: 2
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785188
Page 44 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
1. Repeating Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785189
Page 45 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785190
Page 46 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for Lab
TestVendor Na
meCollection D
ate:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Ide
ntifierTes
t:Resul
t:Repeating
Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785191
Page 47 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785192
Page 48 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785193
Page 49 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785194
Page 50 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785195
Page 51 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785196
Page 52 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785197
Page 53 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785198
Page 54 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785199
Page 55 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785200
Page 56 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785201
Page 57 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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.Start Date: //
6.Ongoing?
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785202
Page 58 of 248
***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: 10161087 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. Repeating Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785203
Page 59 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785204
Page 60 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/01/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785205
Page 61 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/01/2021Form: 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: 10161087 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:
Mar/1/2021
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 [BRLTLS]
5.bSample ID [BSCK74]
5.cSample ID [BSCKNC]
5.dSample ID [BSCKND]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785206
Page 62 of 248
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/12/2020Form: 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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785207
Page 63 of 248
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/12/2020Form: UNPLANNED VISIT
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785208
Page 64 of 248
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/12/2020Form: CONTACT OUTCOME - UNPLANNED
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/12/2020
Contact Outcome:
VISIT ARRANGED
3.Comments: [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785209
Page 65 of 248
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/12/2020Form: VITAL SIGNS - TEMP
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785210
Page 66 of 248
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/12/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Aug/12/2020
2.Injection Site Location DELTOID MUSCLE
3.Injection Site Body Side: LEFT
Reaction
4.aReaction: REDNESS
Reaction Present: NO
4.bReaction: SWELLING
Reaction Present: YES
Maximum Diameter (cm):
[25.0]
Minimum Diameter (cm):
[13.0]
Meets Grade 4 Reaction Criteria:
NO
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: YES
Symptom Grade:
3
Event related to Study Treament?
YES
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: NO
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785211
Page 67 of 248
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/12/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.cSymptom: HEADACHE
Symptom Present: YES
Symptom Grade:
2
Event related to Study Treament?
YES
5.dSymptom: VOMITING
Symptom Present: NO
5.eSymptom: DIARRHEA
Symptom Present: NO
5.fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: YES
Symptom Grade:
2
Event related to Study Treament?
YES
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: NO
5.hSymptom: CHILLS
Symptom Present: NO
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785212
Page 68 of 248
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 22-Apr-2020 21:05 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Aug/31/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785213
Page 69 of 248
***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: 10161087 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: [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785214
Page 70 of 248
***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: 10161087 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:
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785215
Page 71 of 248
***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: 10161087 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 [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785216
Page 72 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EV
ENT 1 injection site swe
lling Aug/10/2020 UNK:
UNK NO
End Date Time:
Aug/19/2020 UNK:UNK
Repeating
Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785217
Page 73 of 248
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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)[injection site swelling]
4.Start Date Time: Aug/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/19/2020 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
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?YES
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785218
Page 74 of 248
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785219
Page 75 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785220
Page 76 of 248
***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: 10161087 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[ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785221
Page 77 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medica
tionStart Da
teForm Instanc
e
1.1 VACCINATIONS NO pfizer bnt162b2 v
accine Jan/14/2
021 Repeating
Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785222
Page 78 of 248
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[pfizer bnt162b2 vaccine]
5.Date: Jan/14/2021
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785223
Page 79 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785224
Page 80 of 248
***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: 10161087 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?
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785225
Page 81 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785226
Page 82 of 248
***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: 10161087 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?
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785227
Page 83 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785228
Page 84 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785229
Page 85 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785230
Page 86 of 248
***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: 10161087 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:
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785231
Page 87 of 248
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785232
Page 88 of 248
***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: 10161087 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?
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785233
Page 89 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785234
Page 90 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785235
Page 91 of 248
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785236
Page 92 of 248
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785237
Page 93 of 248
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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 [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785238
Page 94 of 248
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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 [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785239
Page 95 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785240
Page 96 of 248
***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, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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 NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785241
Page 97 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785242
Page 98 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785243
Page 99 of 248
***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: 10161087 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: [ ]
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785244
Page 100 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Aug/31/2020
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785245
Page 101 of 248
***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: 10161087 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
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785246
Page 102 of 248
***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: 10161087 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
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4)
FDA-CBER-2021-5683-0785247
Page 103 of 248
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-10-2020 15:39:58 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785248
Page 104 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-31-2020 12:15:47 (UTC-05:00) Eastern
Time (US & Canada)not done due to severe injection site reaction at
visit 1, subject to remain in study to complete
remaining visits/telephone contacts but no
further vaccinations
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785249
Page 105 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Aug-31-2020 12:15:47 (UTC-05:00) Eastern
Time (US & Canada)not done due to severe injection site reaction at
visit 1, subject to remain in study to complete
remaining visits/telephone contacts but no further
vaccinations
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785250
Page 106 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Aug-31-2020 12:15:47 (UTC-05:00) Eastern
Time (US & Canada)not done due to severe injection site reaction at
visit 1, subject to remain in study to complete
remaining visits/telephone contacts but no further
vaccinations
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785251
Page 107 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Aug-31-2020 12:15:47 (UTC-05:00) Eastern
Time (US & Canada)not done due to severe injection site reaction at
visit 1, subject to remain in study to complete
remaining visits/telephone contacts but no further
vaccinations
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785252
Page 108 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Aug-31-2020 12:15:47 (UTC-05:00) Eastern
Time (US & Canada)not done due to severe injection site reaction at
visit 1, subject to remain in study to complete
remaining visits/telephone contacts but no further
vaccinations
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785253
Page 109 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Aug-31-2020 12:15:47 (UTC-05:00) Eastern
Time (US & Canada)not done due to severe injection site reaction at
visit 1, subject to remain in study to complete
remaining visits/telephone contacts but no further
vaccinations
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785254
Page 110 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Aug-31-2020 12:15:47 (UTC-05:00) Eastern
Time (US & Canada)not done due to severe injection site reaction at
visit 1, subject to remain in study to complete
remaining visits/telephone contacts but no further
vaccinations
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785255
Page 111 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Aug-31-2020 12:15:47 (UTC-05:00) Eastern
Time (US & Canada)not done due to severe injection site reaction at
visit 1, subject to remain in study to complete
remaining visits/telephone contacts but no further
vaccinations
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785256
Page 112 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Aug-31-2020 12:15:47 (UTC-05:00) Eastern
Time (US & Canada)not done due to severe injection site reaction at
visit 1, subject to remain in study to complete
remaining visits/telephone contacts but no further
vaccinations
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785257
Page 113 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Aug-31-2020 12:15:47 (UTC-05:00) Eastern
Time (US & Canada)not done due to severe injection site reaction at
visit 1, subject to remain in study to complete
remaining visits/telephone contacts but no further
vaccinations
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785258
Page 114 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
10Aug-31-2020 12:15:47 (UTC-05:00) Eastern
Time (US & Canada)not done due to severe injection site reaction at
visit 1, subject to remain in study to complete
remaining visits/telephone contacts but no further
vaccinations
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785259
Page 115 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
11Aug-31-2020 12:15:47 (UTC-05:00) Eastern
Time (US & Canada)not done due to severe injection site reaction at
visit 1, subject to remain in study to complete
remaining visits/telephone contacts but no further
vaccinations
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785260
Page 116 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785261
Page 117 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785262
Page 118 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aSep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785263
Page 119 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.bSep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785264
Page 120 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.cSep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785265
Page 121 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.dSep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785266
Page 122 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.eSep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785267
Page 123 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2 fSep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785268
Page 124 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.gSep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785269
Page 125 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2 hSep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785270
Page 126 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785271
Page 127 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785272
Page 128 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.aSep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785273
Page 129 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.bSep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785274
Page 130 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5.cSep-30-2020 14:49:14 (UTC-05:00) Eastern
Time (US & Canada)pt did not receive 2nd dose of vaccine due to
reaction from first dose of vaccine
Not Done
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0785275
Page 131 of 248
***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: 10161087 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 Feb-01-2021 12:14:21 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-21-2021 22:15:47 (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.
N/A Jan-06-2021 07:56:34 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-16-2020 17:26:00 (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.
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785276
Page 132 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
N/A Nov-16-2020 09:48:03 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Oct-08-2020 16:18:49 (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.
N/A Sep-30-2020 14:48:32 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Approved Sep-15-2020 15:04:37 (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.
N/A Sep-14-2020 14:00:42 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785277
Page 133 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Approved Sep-10-2020 15:01:12 (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.
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785278
Page 134 of 248
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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
Aug-10-2020 15:39:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-10-2020 15:39:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785279
Page 135 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-10-2020 15:39:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/10/2020Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785280
Page 136 of 248
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-10-2020 15:39:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10161087Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-10-2020 15:39:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1976Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-10-2020 15:39:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-10-2020 15:39:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-10-2020 15:39:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3fd0\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-2021-5683-0785281
Page 137 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-10-2020 15:39:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785282
Page 138 of 248
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 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
Aug-10-2020 15:40:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-10-2020 15:40:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-10-2020 15:40:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785283
Page 139 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-10-2020 15:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:hysterectomy
Start Date: Jun/UNK/2015
Ongoing: NO
End Date:
Jun/UNK/2
015Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-10-2020 15:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020 15:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hysterectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-10-2020 15:41:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-10-2020 15:41:05 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3fd0\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-2021-5683-0785284
Page 140 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern
Time (US & Canada)NO
End Date:
Jun/UNK/2015
1.b
Date Location User Value Reason
Aug-10-2020 15:41:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:ovarian fibroid
Start Date: Jan/UNK/2015
Ongoing: NO
End Date:
Jun/UNK/2
015Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785285
Page 141 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-10-2020 15:41:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020 15:41:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ovarian fibroidInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-10-2020 15:41:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-10-2020 15:41:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/UNK/2015Initial Entry
1.c
Date Location User Value Reason
Aug-10-2020 15:42:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:seasonal aller
gies
Start Date: Apr/UNK/199
4
Ongoing: YESInitial Entry
090177e196ae3fd0\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-2021-5683-0785286
Page 142 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-10-2020 15:42:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020 15:42:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
seasonal allergiesInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-10-2020 15:42:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/1994Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-10-2020 15:42:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-10-2020 15:42:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:migraines
Start Date: Apr/UNK/20
10
Ongoing: YESInitial Entry
090177e196ae3fd0\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-2021-5683-0785287
Page 143 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-10-2020 15:42:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020 15:42:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
migrainesInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-10-2020 15:42:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-10-2020 15:42:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-10-2020 15:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:meniscus repai
r
Start Date: Jul/UNK/2009
Ongoing: NO
End Date:
Jul/UNK/2
009Initial Entry
090177e196ae3fd0\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-2021-5683-0785288
Page 144 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-10-2020 15:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020 15:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
meniscus repairInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-10-2020 15:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jul/UNK/2009Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-10-2020 15:43:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jul/UNK/2009Initial Entry
1.f
Date Location User Value Reason
Aug-10-2020 15:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:allergy to fla
gyl
Start Date: Apr/UNK/20
02
Ongoing: YESInitial Entry
090177e196ae3fd0\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-2021-5683-0785289
Page 145 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-10-2020 15:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-10-2020 15:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
allergy to flagylInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-10-2020 15:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/UNK/2002Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-10-2020 15:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fd0\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-2021-5683-0785290
Page 146 of 248
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-10-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-10-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
170.1Initial Entry
3. Unit:
Date Location User Value Reason
Aug-10-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-10-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
70.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-10-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-10-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24.4Initial Entry
090177e196ae3fd0\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-2021-5683-0785291
Page 147 of 248
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a
Date Location User Value Reason
Aug-10-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.4
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-10-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-10-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-10-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-10-2020 15:44:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fd0\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-2021-5683-0785292
Page 148 of 248
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-10-2020 15:45:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-10-2020 15:45:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-10-2020 15:45:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-10-2020 15:45:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-10-2020 15:45:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-10-2020 15:45:43
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785293
Page 149 of 248
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Aug-10-2020 15:45:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-10-2020 15:45:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-10-2020 15:45:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785294
Page 150 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-10-2020 15:46:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-10-2020 15:46:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
44493Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785295
Page 151 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-10-2020 16:25:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020 16:25:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020 16:25:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-10-2020 16:25:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-10-2020 16:25:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/10/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020 16:25:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM82ZGInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785296
Page 152 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-10-2020 16:25:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM82ZGInitial Entry
5.b
Date Location User Value Reason
Aug-10-2020 16:25:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM82ZHInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-10-2020 16:25:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM82ZHInitial Entry
5.c
Date Location User Value Reason
Aug-10-2020 16:25:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM82ZJInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-10-2020 16:25:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM82ZJInitial Entry
5.d
Date Location User Value Reason
Aug-10-2020 16:26:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLCS9VInitial Entry
090177e196ae3fd0\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-2021-5683-0785297
Page 153 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Aug-10-2020 16:26:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLCS9VInitial Entry
5.e
Date Location User Value Reason
Aug-10-2020 16:26:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLCS9WInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-10-2020 16:26:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLCS9WInitial Entry
090177e196ae3fd0\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-2021-5683-0785298
Page 154 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-10-2020 16:26:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-10-2020 16:26:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020 16:26:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-10-2020 16:26:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-10-2020 16:26:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/10/2020Initial Entry
5.a
Date Location User Value Reason
Aug-10-2020 16:26:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8G0RInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785299
Page 155 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-10-2020 16:26:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM8G0RInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785300
Page 156 of 248
***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: 10161087 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
Aug-10-2020 15:46:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-10-2020 15:46:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-10-2020 15:46:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-10-2020 15:46:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/10/2020 10:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-10-2020 15:46:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-10-2020 15:46:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3fd0\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-2021-5683-0785301
Page 157 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Route:
Date Location User Value Reason
Aug-10-2020 15:46:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-10-2020 15:46:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-10-2020 15:46:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785302
Page 158 of 248
***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: 10161087 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
Aug-10-2020 15:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785303
Page 159 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-31-2020 12:06:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785304
Page 160 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIGInitial Entry
090177e196ae3fd0\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-2021-5683-0785305
Page 161 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NO
2.b Symptom:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HEAD
ACHE
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:YES
Ongo
ing?
YE
SInitial Entry
090177e196ae3fd0\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-2021-5683-0785306
Page 162 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Ongoing?
YESInitial Entry
2.d
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fd0\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-2021-5683-0785307
Page 163 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.e
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3fd0\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-2021-5683-0785308
Page 164 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fd0\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-2021-5683-0785309
Page 165 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3fd0\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-2021-5683-0785310
Page 166 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was comp
leted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reactio
n::SWELLI
NGInitial Entry
090177e196ae3fd0\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-2021-5683-0785311
Page 167 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were injection site re
actions present on the
last day the Subject D
iary was completed?:YES
Ongoing
?
NO
Stop
Date:
Aug
/21/
202
0
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/21/2020Initial Entry
5.c
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITEInitial Entry
090177e196ae3fd0\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-2021-5683-0785312
Page 168 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 12:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785313
Page 169 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 12:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2.a
Date Location User Value Reason
Aug-31-2020 12:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 12:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-31-2020 12:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-31-2020 12:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3fd0\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-2021-5683-0785314
Page 170 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-31-2020 12:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785315
Page 171 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-31-2020 12:13:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-31-2020 12:13:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-31-2020 12:13:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-31-2020 12:13:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-31-2020 12:13:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-31-2020 12:13:43
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785316
Page 172 of 248
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-31-2020 12:13:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-31-2020 12:13:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-31-2020 12:13:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785317
Page 173 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 14:44:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 14:44:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-31-2020 14:45:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 14:44:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 14:44:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
Aug-31-2020 14:45:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8G79Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785318
Page 174 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 14:45:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM8G79Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785319
Page 175 of 248
***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: 10161087 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-15-2020 04:08:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Sep-14-2020 14:01:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered EOT has been filled
out
Sep-13-2020 22:11:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Erica Weaver Query 1: Opened DM: Thank you for
confirming that the
subject will not
receive the second
vaccination, please
fill in the EOT form
indicating the reason
for the
discontinuation from
treatment.
Aug-31-2020 12:15:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 12:15:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 12:15:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd0\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) (4)
FDA-CBER-2021-5683-0785320
Page 176 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-31-2020 12:15:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 12:15:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020 12:15:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
7. Route:
Date Location User Value Reason
Aug-31-2020 12:15:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
8. Actual Dose:
Date Location User Value Reason
Aug-31-2020 12:15:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
9. Unit:
Date Location User Value Reason
Aug-31-2020 12:15:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020 12:15:47 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3fd0\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)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0785321
Page 177 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern
Time (US & Canada)Not Done
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-31-2020 12:15:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785322
Page 178 of 248
***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: 10161087 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-30-2020 14:48:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/30/2020Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785323
Page 179 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.a
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Do
neInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.b
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not
DoInitial Entry
090177e196ae3fd0\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-2021-5683-0785324
Page 180 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ne
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Do
ne
2.b Symptom:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.c
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Do
neInitial Entry
090177e196ae3fd0\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-2021-5683-0785325
Page 181 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.d
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Do
neInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.e
Date Location User Value Reason
090177e196ae3fd0\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-2021-5683-0785326
Page 182 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Do
neInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.f
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Do
neInitial Entry
090177e196ae3fd0\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-2021-5683-0785327
Page 183 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.g
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Do
neInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.h
Date Location User Value Reason
090177e196ae3fd0\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-2021-5683-0785328
Page 184 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: Not
Do
ne
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:Not
Do
neInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.a
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: NotInitial Entry
090177e196ae3fd0\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) (4), (b)
(6)
FDA-CBER-2021-5683-0785329
Page 185 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Do
ne
Were injection site reaction
s present on the last day th
e Subject Diary was comple
ted?:Not
Do
ne
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: Not
Do
ne
Were injection site reaction
s present on the last day th
e Subject Diary was comple
ted?:Not
Do
neInitial Entry
090177e196ae3fd0\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-2021-5683-0785330
Page 186 of 248
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.c
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: Not
Do
ne
Were injection site reaction
s present on the last day th
e Subject Diary was comple
ted?:Not
Do
neInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 14:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3fd0\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-2021-5683-0785331
Page 187 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020 16:22:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020 16:22:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020 16:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-30-2020 16:22:04
(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-30-2020 16:22:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020 16:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP8ZT9Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785332
Page 188 of 248
***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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-30-2020 16:22:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP8ZT9Initial Entry
5.b
Date Location User Value Reason
Sep-30-2020 16:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNWZC5Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-30-2020 16:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNWZC5Initial Entry
5.c
Date Location User Value Reason
Sep-30-2020 16:22:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLCS3DInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-30-2020 16:22:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLCS3DInitial Entry
090177e196ae3fd0\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-2021-5683-0785333
Page 189 of 248
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-23-2021 09:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/23/2021Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785334
Page 190 of 248
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-23-2021 11:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-23-2021 11:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-23-2021 11:49:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-23-2021 11:49:30
(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.
Feb-23-2021 11:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/23/2021Initial Entry
5.a
Date Location User Value Reason
Feb-23-2021 11:49:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRLTJJInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785335
Page 191 of 248
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Feb-23-2021 11:49:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRLTJJInitial Entry
5.b
Date Location User Value Reason
Feb-23-2021 11:49:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSCK5GInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-23-2021 11:49:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSCK5GInitial Entry
5.c
Date Location User Value Reason
Feb-23-2021 11:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSCKLWInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-23-2021 11:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSCKLWInitial Entry
5.d
Date Location User Value Reason
Feb-23-2021 11:50:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSCKLXInitial Entry
090177e196ae3fd0\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-2021-5683-0785336
Page 192 of 248
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Feb-23-2021 11:50:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSCKLXInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785337
Page 193 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-01-2021 12:16:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-01-2021 12:14:19
(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.
Feb-01-2021 12:14:19
(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.
Feb-01-2021 12:14:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/1/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-01-2021 12:14:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785338
Page 194 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/1/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/31/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-01-2021 11:03:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
Date of Last Symptom Resolved
:
Feb/7/2021New Information
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae3fd0\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) (4), (b)
(6)
FDA-CBER-2021-5683-0785339
Page 195 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
4.a Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom P
resent:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3fd0\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-2021-5683-0785340
Page 196 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.c Symptoms:
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAINInitial Entry
090177e196ae3fd0\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-2021-5683-0785341
Page 197 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Symptom
Present:YES
4.e Symptoms:
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.g
090177e196ae3fd0\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-2021-5683-0785342
Page 198 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fd0\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-2021-5683-0785343
Page 199 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.i
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-01-2021 12:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Feb-01-2021 12:15:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Other: headacheInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Feb-01-2021 12:15:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
headacheInitial Entry
5.b
Date Location User Value Reason
Feb-01-2021 12:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptoms - Oth
er:nasal congesti
onInitial Entry
090177e196ae3fd0\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-2021-5683-0785344
Page 200 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Symptoms - Other Text:
Date Location User Value Reason
Feb-01-2021 12:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
nasal congestionInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785345
Page 201 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-01-2021 12:15:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785346
Page 202 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-01-2021 12:15:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/1/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-01-2021 12:15:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-01-2021 12:15:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-01-2021 12:15:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Feb-01-2021 12:15:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-01-2021 12:15:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ABBOTT MOLECULAR REALT
IME SARS-COV-2 ASSAYInitial Entry
090177e196ae3fd0\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-2021-5683-0785347
Page 203 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Test Result:
Date Location User Value Reason
Feb-01-2021 12:15:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785348
Page 204 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-01-2021 12:15:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-01-2021 12:15:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-01-2021 12:15:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-01-2021 12:15:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
no self swab collectedInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785349
Page 205 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-01-2021 12:16:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-01-2021 12:16:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-01-2021 12:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-01-2021 12:16:03
(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.
Feb-01-2021 12:16:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/1/2021Initial Entry
5.a
Date Location User Value Reason
Feb-01-2021 12:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR7ZK6Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785350
Page 206 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Feb-01-2021 12:16:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR7ZK6Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785351
Page 207 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practition
er:EMERGEN
CY ROOM
Occurrence of Visi
ts or Contacts:NOInitial Entry
090177e196ae3fd0\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-2021-5683-0785352
Page 208 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Contac
ts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
090177e196ae3fd0\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-2021-5683-0785353
Page 209 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practitioner: URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae3fd0\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-2021-5683-0785354
Page 210 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Type of Practiti
oner:OTHER
Occurrence of
Visits or Contac
ts:YES
Number of Visi
ts or Contacts:
1Initial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
090177e196ae3fd0\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-2021-5683-0785355
Page 211 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2. Other Type of Practitioner Specify:
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
employer-Initial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Feb-01-2021 12:18:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785356
Page 212 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Feb/01/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Feb-01-2021 12:18:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-01-2021 12:18:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-01-2021 12:18:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785357
Page 213 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/01/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1016 Site Name: (1016) Kentucky Pediatric Adult Research
Subject No: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-01-2021 11:03:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/1/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Mar-01-2021 11:03:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COVID_A1Initial Entry
090177e196ae3fd0\Final\Final On: 01-Apr-2021 05:23 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0785358
Page 214 of 248
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/01/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 10161087 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-01-2021 11:05:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021 11:05:18
(UTC-05:00) Eastern
Time (US
…[truncated]