Document text
Page 1 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987800
Page 2 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/23/2020
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987801
Page 3 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11421256]
2.Birth Date: /1975
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987802
Page 4 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987803
Page 5 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987804
Page 6 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/23/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987805
Page 7 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[essential hypertension]
Start Date: Dec/UNK/2009
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sleep apnea]
Start Date: Mar/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/2009
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hysterectomy]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987806
Page 8 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tummy tuck]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987807
Page 9 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/23/2020
2.Weight: [147.2]
3.Unit: LB
4.Height: [61.0]
5.Unit: in
6.Body Mass Index: [27.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987808
Page 10 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/23/2020
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
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987809
Page 11 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/23/2020
2.Randomization Number: [96511]
3.Randomization Group: [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987810
Page 12 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BS6S9K]
5.bSample ID [BS6S9L]
5.cSample ID [BS6S9M]
5.dSample ID [BP9V69]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987811
Page 13 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/23/2020
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 [BP9V6F]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987812
Page 14 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/23/2020 13:30
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
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987813
Page 15 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987814
Page 16 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987815
Page 17 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987816
Page 18 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/12/2020
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
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987817
Page 19 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR91H9]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987818
Page 20 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/12/2020 15:00
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
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987819
Page 21 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987820
Page 22 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/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 [BSMCT8]
5.bSample ID [BSMCTD]
5.cSample ID [BRCCLP]
5.dSample ID [BRCCLR]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987821
Page 23 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987822
Page 24 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987823
Page 25 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987824
Page 26 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987825
Page 27 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987826
Page 28 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987827
Page 29 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987828
Page 30 of 175
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987829
Page 31 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987830
Page 32 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987831
Page 33 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987832
Page 34 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987833
Page 35 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE E
VENT 1 left axillary lymph node
swelling Dec/17/2020 06:0
0 NO
End Date Time:
Dec/19/2020 UNK:UN
K
Repeating
Pages
2.ADVERSE E
VENT 2 right cervical lymph nod
e swelling Dec/24/2020 UN
K:UNK NO
End Date Time:
Dec/25/2020 UNK:UN
K
Repeating
Pages
3.ADVERSE E
VENT 3 swollen left axillary lym
ph node Jan/7/2021 UNK:
UNK NO
End Date Time:
Jan/10/2021 UNK:UN
K
Repeating
Pages
4.ADVERSE E
VENT 4 swollen right cervical ly
mph node Jan/12/2021 UN
K:UNK NO
End Date Time:
Jan/19/2021 UNK:UN
K
Repeating
Pages
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987834
Page 36 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[left axillary lymph node swelling]
4.Start Date Time: Dec/17/2020 06:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/19/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987835
Page 37 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987836
Page 38 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[right cervical lymph node swelling]
4.Start Date Time: Dec/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/25/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987837
Page 39 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987838
Page 40 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[swollen left axillary lymph node]
4.Start Date Time: Jan/7/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987839
Page 41 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987840
Page 42 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[swollen right cervical lymph node]
4.Start Date Time: Jan/12/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/19/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[lymph adenitis]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987841
Page 43 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987842
Page 44 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987843
Page 45 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987844
Page 46 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987845
Page 47 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987846
Page 48 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987847
Page 49 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987848
Page 50 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987849
Page 51 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987850
Page 52 of 175
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987851
Page 53 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987852
Page 54 of 175
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987853
Page 55 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987854
Page 56 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987855
Page 57 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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:
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987856
Page 58 of 175
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987857
Page 59 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987858
Page 60 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987859
Page 61 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987860
Page 62 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/14/2020
2.Erroneous Visit
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987861
Page 63 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987862
Page 64 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987863
Page 65 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/16/2020
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987864
Page 66 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987865
Page 67 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Dec/16/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987866
Page 68 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/16/2020
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
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987867
Page 69 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/16/2020
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 [BR3NT5]
5.bSample ID [BR3NT6]
5.cSample ID [BLGC4B]
5.dSample ID [BLGBV4]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987868
Page 70 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/16/2020
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 [BR3NT0]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987869
Page 71 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/16/2020 10:33
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987870
Page 72 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/15/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987871
Page 73 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987872
Page 74 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987873
Page 75 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987874
Page 76 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/5/2021
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
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987875
Page 77 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/5/2021
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 [BRR5G0]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987876
Page 78 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/5/2021 13:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987877
Page 79 of 175
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987878
Page 80 of 175
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/23/2021
3.Comments: [2 day after V101 and V102 swollen lymph node on side of vaccination for 3
days. opposite side neck lymph node swollen 2wk after V101 and V102.
moderate]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987879
Page 81 of 175
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987880
Page 82 of 175
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987881
Page 83 of 175
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987882
Page 84 of 175
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987883
Page 85 of 175
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/23/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987884
Page 86 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/10/2020
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987885
Page 87 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987886
Page 88 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Richard Rupp Approved Mar-11-2021 07:40:08 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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.
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987887
Page 89 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-23-2020 14:09:45 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987888
Page 90 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormDec-16-2020 13:24:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987889
Page 91 of 175
***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, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Richard Rupp Approved Mar-11-2021 07:40:08 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-23-2021 18:23:40 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Rupp Approved Jan-22-2021 09:05:51 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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 Dec-16-2020 13:23:30 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987890
Page 92 of 175
***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, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Richard Rupp Approved Nov-11-2020 10:24:59 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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.
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987891
Page 93 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-23-2020 14:08:32
(UTC-06:00) Central
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
Sep-23-2020 14:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987892
Page 94 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-23-2020 14:08:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/23/2020Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987893
Page 95 of 175
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-23-2020 14:08:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11421256Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-23-2020 14:08:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1975Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-23-2020 14:09:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-23-2020 14:09:07
(UTC-06:00) Central
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
Sep-23-2020 14:09:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AMERI
CANInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987894
Page 96 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-23-2020 14:09:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987895
Page 97 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-23-2020 14:10:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020 14:10:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020 14:10:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987896
Page 98 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Sep-23-2020 14:10:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:essential hypert
ension
Start Date: Dec/UNK/2009
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-23-2020 14:10:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 14:10:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
essential hypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-23-2020 14:10:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/UNK/2009Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-23-2020 14:10:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987897
Page 99 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b
Date Location User Value Reason
Sep-23-2020 14:11:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:sleep apnea
Start Date: Mar/UNK/20
15
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-23-2020 14:11:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-23-2020 14:11:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
sleep apneaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-23-2020 14:11:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-23-2020 14:11:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987898
Page 100 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-23-2020 14:11:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:GERD
Start Date: UNK/UNK/2
009
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-23-2020 14:11:32
(UTC-06:00) Central
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
Sep-23-2020 14:11:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GERDInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-23-2020 14:11:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-23-2020 14:11:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-23-2020 14:12:21
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb 4Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987899
Page 101 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) er:
Medical History
Term:hysterectomy
Start Date: UNK/UNK/201
9
Ongoing: NO
End Date:
UNK/UNK/
2019
1.d Line/MH Number:
Date Location User Value Reason
Sep-23-2020 14:12:21
(UTC-06:00) Central
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
Sep-23-2020 14:12:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hysterectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-23-2020 14:12:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-23-2020 14:12:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.e
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987900
Page 102 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-23-2020 14:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:tummy tuck
Start Date: UNK/UNK/201
8
Ongoing: NO
End Date:
UNK/UNK/
2018Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987901
Page 103 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-23-2020 14:12:47
(UTC-06:00) Central
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
Sep-23-2020 14:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
tummy tuckInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-23-2020 14:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-23-2020 14:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987902
Page 104 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-23-2020 14:13:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-23-2020 14:13:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
147.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-23-2020 14:13:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-23-2020 14:13:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
61.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-23-2020 14:13:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-23-2020 14:13:18
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27.8Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987903
Page 105 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-23-2020 14:13:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.2
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-23-2020 14:13:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-23-2020 14:13:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-23-2020 14:13:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-23-2020 14:13:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987904
Page 106 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-23-2020 14:13:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-23-2020 14:13:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-23-2020 14:13:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-23-2020 14:13:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-23-2020 14:13:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987905
Page 107 of 175
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-23-2020 14:13:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-23-2020 14:13:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-23-2020 14:13:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-23-2020 14:13:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987906
Page 108 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-23-2020 14:13:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-23-2020 18:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
96511Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987907
Page 109 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 14:13:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 14:13:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 23:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 14:13:38
(UTC-06:00) Central
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-23-2020 14:13:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020 23:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS6S9KInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987908
Page 110 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 23:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS6S9KInitial Entry
5.b
Date Location User Value Reason
Sep-23-2020 23:35:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS6S9LInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-23-2020 23:35:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS6S9LInitial Entry
5.c
Date Location User Value Reason
Sep-23-2020 23:35:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS6S9MInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-23-2020 23:35:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS6S9MInitial Entry
5.d
Date Location User Value Reason
Sep-23-2020 23:35:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9V69Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987909
Page 111 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Sep-23-2020 23:35:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9V69Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987910
Page 112 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 14:13:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 14:13:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 23:29:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 14:13:45
(UTC-06:00) Central
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-23-2020 14:13:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/23/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020 23:29:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9V6FInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987911
Page 113 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 23:29:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9V6FInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987912
Page 114 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-23-2020 14:14:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020 14:14:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020 14:14:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-23-2020 14:14:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/23/2020 13:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020 14:14:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-23-2020 14:14:05
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987913
Page 115 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-23-2020 14:14:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-23-2020 14:14:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-23-2020 14:14:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987914
Page 116 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-23-2020 14:14:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987915
Page 117 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-12-2020 15:38:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987916
Page 118 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-12-2020 15:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
2.a
Date Location User Value Reason
Oct-12-2020 15:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 98.7
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-12-2020 15:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-12-2020 15:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-12-2020 15:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987917
Page 119 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.a Temperature Location:
Date Location User Value Reason
Oct-12-2020 15:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987918
Page 120 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-12-2020 15:40:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-12-2020 15:40:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-12-2020 15:40:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-12-2020 15:40:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-12-2020 15:40:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987919
Page 121 of 175
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-12-2020 15:40:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-12-2020 15:40:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-12-2020 15:40:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-12-2020 15:40:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987920
Page 122 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 14:56:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 14:56:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 14:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 14:56:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-12-2020 14:56:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020 14:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR91H9Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987921
Page 123 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Oct-12-2020 14:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR91H9Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987922
Page 124 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-12-2020 15:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-12-2020 15:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-12-2020 15:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-12-2020 15:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/12/2020 15:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-12-2020 15:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-12-2020 15:40:32
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987923
Page 125 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-12-2020 15:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-12-2020 15:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-12-2020 15:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987924
Page 126 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020 11:12:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987925
Page 127 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020 11:12:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020 11:12:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-10-2020 17:43:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-10-2020 11:12:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-10-2020 11:12:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/10/2020Initial Entry
5.a
Date Location User Value Reason
Nov-10-2020 17:43:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMCT8Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987926
Page 128 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Nov-10-2020 17:43:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSMCT8Initial Entry
5.b
Date Location User Value Reason
Nov-10-2020 17:43:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSMCTDInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-10-2020 17:43:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSMCTDInitial Entry
5.c
Date Location User Value Reason
Nov-10-2020 17:45:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRCCLPInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-10-2020 17:45:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCCLPInitial Entry
5.d
Date Location User Value Reason
Nov-10-2020 17:45:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRCCLRInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987927
Page 129 of 175
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Nov-10-2020 17:45:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRCCLRInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987928
Page 130 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Dec-24-2020 11:28:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987929
Page 131 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Jan-08-2021 12:32:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987930
Page 132 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987931
Page 133 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987932
Page 134 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Dec-24-2020 11:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-24-2020 11:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-24-2020 11:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
left axillary lymph node swellingInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-08-2021 12:28:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/17/2020 06:00Transcription Error
Dec-24-2020 11:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/18/2020 06:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-08-2021 12:28:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/19/2020 UNK:UNKNew Information
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987933
Page 135 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Dec-24-2020 11:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-24-2020 11:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-24-2020 11:28:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-29-2020 02:36:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-28-2020 16:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Dec-28-2020 16:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
Dec-27-2020 23:16:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for Data item#8 to
14 are missing.
Kindly review and
update.
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987934
Page 136 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-28-2020 16:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-28-2020 16:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-28-2020 16:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-28-2020 16:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-08-2021 21:53:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-08-2021 21:53:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDNew Information
Jan-08-2021 12:28:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE left axillary
lymph node swelling:
Response to "What
was the outcome of
this adverse event?" is
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987935
Page 137 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
'Recovering/Resolving'
but AE End Date/Time
is present.
Dec-28-2020 16:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-28-2020 16:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987936
Page 138 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
right cervical lymph node swellin
gInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/24/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/25/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987937
Page 139 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987938
Page 140 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-11-2021 22:52:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-11-2021 15:37:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Jan-11-2021 15:37:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NONew Information
Jan-11-2021 00:35:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "Was a
Non-Drug
Treatment given?"
is missing. Kindly
review and update.
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-08-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987939
Page 141 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
swollen left axillary lymph nodeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/7/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/10/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987940
Page 142 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987941
Page 143 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-02-2021 15:24:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987942
Page 144 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
swollen right cervical lymph nod
eInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/12/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/19/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987943
Page 145 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
lymph adenitisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987944
Page 146 of 175
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-02-2021 15:25:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987945
Page 147 of 175
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-10-2020 11:12:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-10-2020 11:12:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-10-2020 11:12:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987946
Page 148 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-16-2020 13:23:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/14/2020Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987947
Page 149 of 175
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-16-2020 13:34:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-16-2020 13:23:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Dec-16-2020 13:23:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirme
d to have received only place
bo at Vaccination 1/2Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987948
Page 150 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-16-2020 13:24:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/16/2020Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987949
Page 151 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-16-2020 13:24:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/16/2020Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987950
Page 152 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-16-2020 13:25:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-16-2020 13:25:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-16-2020 13:25:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987951
Page 153 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-16-2020 13:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-16-2020 13:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-16-2020 13:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-16-2020 13:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-16-2020 13:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987952
Page 154 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Dec-16-2020 13:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-16-2020 13:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-16-2020 13:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Dec-16-2020 13:26:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987953
Page 155 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-16-2020 13:26:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-16-2020 13:26:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 11:43:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-17-2020 03:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-16-2020 13:26:36
(UTC-06:00) Central
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.
Dec-16-2020 13:26:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/16/2020Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987954
Page 156 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Dec-17-2020 11:43:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR3NT5Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 11:43:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR3NT5Initial Entry
5.b
Date Location User Value Reason
Dec-17-2020 11:43:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR3NT6Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-17-2020 11:43:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR3NT6Initial Entry
5.c
Date Location User Value Reason
Dec-17-2020 11:44:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGC4BInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-17-2020 11:44:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLGC4BInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0987955
Page 157 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d
Date Location User Value Reason
Dec-17-2020 12:53:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLGBV4Initial Entry
5.d Sample ID
Date Location User Value Reason
Dec-17-2020 12:53:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLGBV4Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987956
Page 158 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-16-2020 13:26:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-16-2020 13:26:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 11:41:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-17-2020 03:00:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-16-2020 13:26:47
(UTC-06:00) Central
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.
Dec-16-2020 13:26:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/16/2020Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987957
Page 159 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Dec-17-2020 11:41:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR3NT0Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 11:41:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR3NT0Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987958
Page 160 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-16-2020 13:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-16-2020 13:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-16-2020 13:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-16-2020 13:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/16/2020 10:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-16-2020 13:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-16-2020 13:27:06
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987959
Page 161 of 175
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Dec-16-2020 13:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-16-2020 13:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-16-2020 13:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-16-2020 13:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-16-2020 13:27:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987960
Page 162 of 175
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-17-2020 14:18:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020New Information
Dec-16-2020 13:34:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/14/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-16-2020 13:34:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987961
Page 163 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-05-2021 15:09:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/5/2021Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987962
Page 164 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-05-2021 15:09:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-05-2021 15:09:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-05-2021 15:09:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/5/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-05-2021 15:09:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-05-2021 15:09:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987963
Page 165 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-05-2021 15:09:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-05-2021 15:09:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-05-2021 15:09:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Jan-05-2021 15:09:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987964
Page 166 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-05-2021 15:09:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-05-2021 15:09:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-06-2021 16:21:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-06-2021 04:44:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-05-2021 15:09:33
(UTC-06:00) Central
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.
Jan-05-2021 15:09:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/5/2021Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987965
Page 167 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a
Date Location User Value Reason
Jan-06-2021 16:21:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRR5G0Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-06-2021 16:21:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRR5G0Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987966
Page 168 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-05-2021 15:09:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-05-2021 15:09:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-05-2021 15:09:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-05-2021 15:09:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/5/2021 13:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-05-2021 15:09:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-05-2021 15:09:55
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987967
Page 169 of 175
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-05-2021 15:09:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-05-2021 15:09:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-05-2021 15:09:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-05-2021 15:09:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-05-2021 15:09:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987968
Page 170 of 175
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-01-2021
01:07:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: ClosedResponse
satisfies query
Feb-26-2021
13:11:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2
: Answe
redOriginal value is
correct
Feb-26-2021
02:03:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 2
: Opene
dPDQ: Date of
visit
V103_MONTH1
is out of window
for 14 days from
V102_VAX4
DOV or
Vaccination date.
Please verify and
update. Else,
confirm in query
response
appropriately.
"[
]"
Feb-24-2021
23:39:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: ClosedResponse
satisfies query
Feb-24-2021
14:16:20
(UTC-06:00)
Central TimeACV0PFEINFP6000 Query 1
: Answe
redChanged data per
query
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987969
Page 171 of 175
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US &
Canada)
Feb-24-2021
06:18:21
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Opene
dDM: Patient
completed
Vaccination 3
visit through the
1-month post
vaccination visit
after the
Vaccination 4.
Please complete
treatment
disposition CRF
and update date
of EOT2 to
match date of
visit at visit 103.
Feb-23-2021
18:23:40
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Feb/23/
2021Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987970
Page 172 of 175
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-23-2021 18:25:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-23-2021 18:25:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Feb/23/2021Initial Entry
3. Comments:
Date Location User Value Reason
Feb-23-2021 18:25:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2 day after V101 and V102 swoll
en lymph node on side of vaccina
tion for 3 days. opposite side nec
k lymph node swollen 2wk after
V101 and V102. moderateInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987971
Page 173 of 175
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Feb-25-2021
06:43:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedincorrect
Feb-25-2021
06:04:47
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7450780;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Feb-24-2021
14:16:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Feb/2
3/202
1Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-24-2021 14:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Feb-24-2021 14:16:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987972
Page 174 of 175
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-10-2020 11:12:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-23-2020 14:13:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-23-2020 14:10:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-10-2020 11:12:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/10/2020Initial Entry
Sep-23-2020 14:13:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/23/2020Initial Entry
Sep-23-2020 14:10:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/23/2020Initial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987973
Page 175 of 175
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421256 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-12-2020 14:00:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e3e\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987974