125742 S1 M5 CRF c4591001 1170 11701090

Document text

Page 1 of 207
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943674
Page 2 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/26/2020
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943675
Page 3 of 207
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11701090]
2.Birth Date: /1948
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943676
Page 4 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943677
Page 5 of 207
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943678
Page 6 of 207
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/26/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943679
Page 7 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943680
Page 8 of 207
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
2.Weight: [121.0]
3.Unit: kg
4.Height: [180.34]
5.Unit: cm
6.Body Mass Index: [37.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943681
Page 9 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/26/2020
2.Randomization Number: [241554]
3.Randomization Group: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943682
Page 10 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BPYHSH]
5.bSample ID [BPYHSJ]
5.cSample ID [BPYHSK]
5.dSample ID [BNW703]
5.eSample ID [BNW704]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943683
Page 11 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/26/2020
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 [BPYHSL]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943684
Page 12 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/26/2020 12:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943685
Page 13 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943686
Page 14 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943687
Page 15 of 207
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943688
Page 16 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BGJKKH]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943689
Page 17 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/16/2020 10:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943690
Page 18 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/14/2020
2.Erroneous Visit
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943691
Page 19 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRX8NF]
5.bSample ID [BRX8NG]
5.cSample ID [BGK0CD]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943692
Page 20 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943693
Page 21 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943694
Page 22 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943695
Page 23 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943696
Page 24 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943697
Page 25 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943698
Page 26 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943699
Page 27 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943700
Page 28 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943701
Page 29 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943702
Page 30 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/14/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943703
Page 31 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943704
Page 32 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943705
Page 33 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943706
Page 34 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yAE Id
entifie
rAdverse Event Start DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
 1. ADVER
SE EVE
NT 1 Fatigue  Sep/23/202
0 UNK:UN
K NO
End Date Time:
Sep/24/2020 U
NK:UNK
 Repeating
Pages
 2. ADVER
SE EVE
NT 2 Malaise  Sep/23/202
0 UNK:UN
K NO
End Date Time:
Sep/24/2020 U
NK:UNK
 Repeating
Pages
 3. ADVER
SE EVE
NT 3 General Weakness  Oct/1/2020
UNK:UNK
 NO
End Date Time:
Oct/31/2020 U
NK:UNK
 Repeating
Pages
 4. ADVER
SE EVE
NT 4 Dizziness  Oct/1/2020
UNK:UNK
 NO
End Date Time:
Oct/31/2020 U
NK:UNK
 Repeating
Pages
 5. ADVER
SE EVE
NT 5 Blurred Vision  Oct/1/2020
UNK:UNK
 NO
End Date Time:
Oct/31/2020 U
NK:UNK
 Repeating
Pages
 6. ADVER
SE EVE
NT 6 Syncope  Oct/1/2020
UNK:UNK
 NO
End Date Time:
Oct/1/2020 U
NK:UNK
 Repeating
Pages
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943707
Page 35 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yAE Id
entifie
rAdverse Event Start DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
 7. ADVER
SE EVE
NT 7 Newly Diagnosed Coronary Art
ery Disease Oct/1/2020
UNK:UNK
 NO
End Date Time:
Dec/17/2020
UNK:UNK
 Repeating
Pages
 8. DELETED ADVER
SE EVE
NT 8 Placement of Coronary Arterial
Stent in Left Circumflex Coron
ary Artery Dec/16/202
0 UNK:UN
K NO
End Date Time:
Dec/17/2020
UNK:UNK
 Repeating
Pages
 9. ADVER
SE EVE
NT 9 Shortness of Breath  Oct/1/2020
UNK:UNK
 NO
End Date Time:
Dec/17/2020
UNK:UNK
 Repeating
Pages
 10. ADVER
SE EVE
NT 10 Pain at injection site  Jan/28/202
1 UNK:UN
K NO
End Date Time:
Jan/29/2021 U
NK:UNK
 Repeating
Pages
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943708
Page 36 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Fatigue]
4.Start Date Time: Sep/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/24/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943709
Page 37 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943710
Page 38 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Malaise]
4.Start Date Time: Sep/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/24/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943711
Page 39 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943712
Page 40 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[General Weakness]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/31/2020 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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943713
Page 41 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[Subject instructed to seek out care from PCP to get accurate diagnosis.]
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[ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943714
Page 42 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Dizziness]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/31/2020 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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943715
Page 43 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[Subject instructed to seek out care from PCP to get accurate diagnosis.]
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[ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943716
Page 44 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Blurred Vision]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/31/2020 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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943717
Page 45 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[Subject instructed to seek out care from PCP to get accurate diagnosis.]
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[ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943718
Page 46 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Syncope]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/1/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943719
Page 47 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[Subject was advised to seek care from PCP to get accurate diagnosis.]
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[ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943720
Page 48 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Newly Diagnosed Coronary Artery Disease]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/17/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943721
Page 49 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[Hyperlipidemia, Hypertension, and Obesity]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?YES
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[2021082332]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943722
Page 50 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Placement of Coronary Arterial Stent in Left Circumflex Coronary Artery ]
4.Start Date Time: Dec/16/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/17/2020 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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943723
Page 51 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[Related to Coronary Artery Disease ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943724
Page 52 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Shortness of Breath]
4.Start Date Time: Oct/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/17/2020 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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943725
Page 53 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[Coronary Artery Disease]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
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[ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943726
Page 54 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Pain at injection site]
4.Start Date Time: Jan/28/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/29/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943727
Page 55 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943728
Page 56 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943729
Page 57 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943730
Page 58 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943731
Page 59 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: //
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943732
Page 60 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943733
Page 61 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943734
Page 62 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943735
Page 63 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943736
Page 64 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943737
Page 65 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943738
Page 66 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943739
Page 67 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943740
Page 68 of 207
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943741
Page 69 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943742
Page 70 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943743
Page 71 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943744
Page 72 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943745
Page 73 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/4/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943746
Page 74 of 207
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943747
Page 75 of 207
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943748
Page 76 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943749
Page 77 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/27/2021
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943750
Page 78 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943751
Page 79 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/27/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943752
Page 80 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
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 [BPSC11]
5.bSample ID [BSGDDJ]
5.cSample ID [BSGDDK]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943753
Page 81 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/27/2021
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 [BPSC0Z]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943754
Page 82 of 207
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/27/2021 15:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943755
Page 83 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943756
Page 84 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/22/2021
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 [BPSBFS]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943757
Page 85 of 207
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/22/2021 14:39
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943758
Page 86 of 207
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943759
Page 87 of 207
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943760
Page 88 of 207
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943761
Page 89 of 207
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943762
Page 90 of 207
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943763
Page 91 of 207
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943764
Page 92 of 207
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943765
Page 93 of 207
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/14/2020
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943766
Page 94 of 207
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943767
Page 95 of 207
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Mezgebe
Berhe Approved Mar-12-2021 18:56:11 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MezgebeBerhe, 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.
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943768
Page 96 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-26-2020 13:46:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943769
Page 97 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
FormJan-29-2021 09:47:03 (UTC-06:00) Central
Time (US & Canada)Inform not working, won't let me delete
FormJan-29-2021 09:47:00 (UTC-06:00) Central
Time (US & Canada)Inform will not allow me to remove/delete
AE.
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943770
Page 98 of 207
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-28-2021 09:22:21 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943771
Page 99 of 207
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Jan-28-2021 09:22:21 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943772
Page 100 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-28-2021 09:20:42 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943773
Page 101 of 207
***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, Frozen, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Mezgebe
Berhe Approved Mar-12-2021 18:56:11 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MezgebeBerhe, verify that all case report form pages accurately display the results
of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-27-2021 16:12:51 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mezgebe
Berhe Approved Nov-11-2020 15:59:13 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MezgebeBerhe, 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 Nov-09-2020 10:50:30 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943774
Page 102 of 207
***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, Frozen, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
N/A
Mezgebe
Berhe Approved Oct-23-2020 10:54:18 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MezgebeBerhe, 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.
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943775
Page 103 of 207
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-26-2020 13:45:52
(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
Aug-26-2020 13:45:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943776
Page 104 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-26-2020 13:45:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Aug/26/2020Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943777
Page 105 of 207
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020 13:44:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11701090Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020 13:44:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1948Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020 13:46:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-26-2020 13:46:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-26-2020 13:46:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943778
Page 106 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-26-2020 13:46:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943779
Page 107 of 207
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-26-2020 13:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020 13:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020 13:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943780
Page 108 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-26-2020 13:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Hypertensio
n
Start Date: UNK/UNK/
2010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-26-2020 13:47:27
(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
Aug-26-2020 13:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-26-2020 13:47:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-26-2020 13:47:27 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0943781
Page 109 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)YES
1.b
Date Location User Value Reason
Aug-26-2020 13:47:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Hyperlipide
mia
Start Date: UNK/UNK/
2010
Ongoing: YESInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0943782
Page 110 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Aug-26-2020 13:47:43
(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
Aug-26-2020 13:47:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HyperlipidemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-26-2020 13:47:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-26-2020 13:47:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943783
Page 111 of 207
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020 13:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-26-2020 13:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
121.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-26-2020 13:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-26-2020 13:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
180.34Initial Entry
5. Unit:
Date Location User Value Reason
Aug-26-2020 13:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943784
Page 112 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-26-2020 13:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
37.2Initial Entry
7.a
Date Location User Value Reason
Aug-26-2020 13:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 97.8
Temperature Unit
:F
Temperature Loc
ation::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 13:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-26-2020 13:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-26-2020 13:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943785
Page 113 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-26-2020 13:48:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943786
Page 114 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-26-2020 13:48:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-26-2020 13:48:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
241554Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943787
Page 115 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 13:50:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 13:50:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020 13:51:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-26-2020 13:50:01
(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.
Aug-26-2020 13:50:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943788
Page 116 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-26-2020 13:51:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYHSHInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 13:51:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPYHSHInitial Entry
5.b
Date Location User Value Reason
Aug-26-2020 13:51:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYHSJInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-26-2020 13:51:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPYHSJInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020 13:51:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYHSKInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-26-2020 13:51:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPYHSKInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943789
Page 117 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d
Date Location User Value Reason
Aug-26-2020 13:52:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW703Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-26-2020 13:52:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW703Initial Entry
5.e
Date Location User Value Reason
Aug-26-2020 13:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW704Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-26-2020 13:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW704Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943790
Page 118 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 13:50:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 13:50:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020 13:50:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-26-2020 13:50:08
(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.
Aug-26-2020 13:50:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/26/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943791
Page 119 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-26-2020 13:50:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYHSLInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 13:50:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPYHSLInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943792
Page 120 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-26-2020 13:48:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020 13:48:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020 13:48:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-26-2020 14:23:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020 12:10Transcription Error
Aug-26-2020 13:48:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020 13:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020 13:48:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943793
Page 121 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
6. Body Side:
Date Location User Value Reason
Aug-26-2020 13:48:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-26-2020 13:48:36
(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
Aug-26-2020 13:48:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-26-2020 13:48:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943794
Page 122 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-09-2020 03:08:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-03-2020 10:14:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-03-2020 10:14:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECT
ED FOR THIS SUBJECTTranscription Error
Sep-03-2020 04:17:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary:
REACTOGENICITY
E-DIARY
COLLECTED FOR
THIS SUBJECT is
'Yes' however VAX 1
eDiary records are
not available for the
subject. Please verify
and update. Else,
confirm in query
response
appropriately.
Aug-26-2020 13:48:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICIT
Y E DIARY COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943795
Page 123 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-16-2020 12:49:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943796
Page 124 of 207
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-16-2020 12:49:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Sep-16-2020 12:49:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 97.4
Temperature Uni
t:F
Temperature Loc
ation::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-16-2020 12:49:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-16-2020 12:49:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-16-2020 12:49:53 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0943797
Page 125 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)F
2.a Temperature Location:
Date Location User Value Reason
Sep-16-2020 12:49:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943798
Page 126 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 12:50:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 12:50:01
(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-16-2020 12:52:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-16-2020 12:50:01
(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-16-2020 12:50:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943799
Page 127 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-16-2020 12:52:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BGJKKHInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 12:52:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BGJKKHInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943800
Page 128 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-16-2020 12:50:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020 12:50:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-16-2020 12:50:23
(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-16-2020 12:50:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020 10:27Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-16-2020 12:50:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943801
Page 129 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-16-2020 12:50:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020 12:50:23
(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-16-2020 12:50:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-16-2020 12:50:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943802
Page 130 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020 12:04:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-10-2020 08:38:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Illness ediary entry
was deemed
erroneous.
Nov-10-2020 02:51:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened RQ1: Response
states 'reported
illness not related
to COVID or
vaccine
reactogenicity'.
Please confirm if
Illness ediary entry
on 04NOV2020
was deemed
erroneous and that
subject had no
symptoms.
Nov-09-2020 10:53:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Subject reported
illness not related
to COVID or
vaccine
reactogenicity and
was told to see
PCP for symptoms
he experienced
throughout the
month of October.
Nov-09-2020 10:43:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Illness eDiary: As
per Illness ediary
records, subject
reported "Yes" for
the question "Have
you experienced
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0943803
Page 131 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
any of the
following?” for the
COVID-19
symptoms or
diagnosis on
04NOV2020. But
there is no COVID
Illness visit
reported in the
database.
Oct-20-2020 00:22:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-19-2020 09:14:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Query Answered.
Oct-16-2020 04:41:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Patient
completed the
treatment phase
and reached at
Visit 3. Kindly
consider to update
EOT form with
matching V3 date
or else clarify.
Thank you.
Oct-14-2020 10:23:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943804
Page 132 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-14-2020 11:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-14-2020 11:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-14-2020 11:36:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-14-2020 11:36:43
(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-14-2020 11:36:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/14/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943805
Page 133 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-14-2020 11:36:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRX8NFInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-14-2020 11:36:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRX8NFInitial Entry
5.b
Date Location User Value Reason
Oct-14-2020 11:37:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRX8NGInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-14-2020 11:37:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRX8NGInitial Entry
5.c
Date Location User Value Reason
Oct-14-2020 11:37:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BGK0CDInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-14-2020 11:37:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BGK0CDInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943806
Page 134 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-19-2020 09:14:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 09:14:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 09:14:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943807
Page 135 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-09-2020 10:50:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943808
Page 136 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-09-2020 10:58:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943809
Page 137 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-09-2020 10:59:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943810
Page 138 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-09-2020 11:00:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943811
Page 139 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-09-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943812
Page 140 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-09-2020 11:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943813
Page 141 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Jan-27-2021 16:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943814
Page 142 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-03-2021 15:41:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Jan-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943815
Page 143 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Feb-03-2021 15:43:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943816
Page 144 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Mar-01-2021 11:12:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943817
Page 145 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Nov-09-2020 10:50:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-09-2020 10:50:30
(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
Nov-09-2020 10:50:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FatigueInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-09-2020 10:50:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-09-2020 10:50:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/24/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943818
Page 146 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-09-2020 10:50:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-09-2020 10:50:30
(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
Nov-09-2020 10:50:30
(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
Nov-09-2020 10:50:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-09-2020 10:50:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943819
Page 147 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-09-2020 10:50:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-09-2020 10:50:30
(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
Nov-09-2020 10:50:30
(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
Nov-09-2020 10:50:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943820
Page 148 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Nov-09-2020 10:58:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-09-2020 10:58:13
(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
Nov-09-2020 10:58:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MalaiseInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-09-2020 10:58:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 UNK:UNKInitial Entry
5  Is the adverse event still ongoing?
Date Location User Value Reason
Nov-09-2020 10:58:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/24/2020 UNK:UNKInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943821
Page 149 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
6. Toxicity Grade:
Date Location User Value Reason
Nov-09-2020 10:58:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-09-2020 10:58:13
(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
Nov-09-2020 10:58:13
(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
Nov-09-2020 10:58:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-09-2020 10:58:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943822
Page 150 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-09-2020 10:58:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-09-2020 10:58:13
(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
Nov-09-2020 10:58:13
(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
Nov-09-2020 10:58:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943823
Page 151 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Nov-09-2020 10:59:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-09-2020 10:59:26
(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
Nov-09-2020 10:59:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
General WeaknessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-09-2020 10:59:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 UNK:UNKInitial Entry
5  Is the adverse event still ongoing?
Date Location User Value Reason
Nov-09-2020 10:59:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/31/2020 UNK:UNKInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943824
Page 152 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
6. Toxicity Grade:
Date Location User Value Reason
Nov-09-2020 10:59:26
(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
Nov-09-2020 10:59:26
(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
Nov-09-2020 10:59:26
(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
Nov-09-2020 10:59:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
Subject instructed to seek
out care from PCP to getInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943825
Page 153 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
accurate diagnosis.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-09-2020 10:59:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-09-2020 10:59:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-09-2020 10:59:26
(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
Nov-09-2020 10:59:26
(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
Nov-09-2020 10:59:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943826
Page 154 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Nov-09-2020 11:00:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-09-2020 11:00:10
(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
Nov-09-2020 11:00:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DizzinessInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-09-2020 11:00:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 UNK:UNKInitial Entry
5  Is the adverse event still ongoing?
Date Location User Value Reason
Nov-09-2020 11:00:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/31/2020 UNK:UNKInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943827
Page 155 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
6. Toxicity Grade:
Date Location User Value Reason
Nov-09-2020 11:00:10
(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
Nov-09-2020 11:00:10
(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
Nov-09-2020 11:00:10
(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
Nov-09-2020 11:00:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
Subject instructed to seek
out care from PCP to getInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943828
Page 156 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
accurate diagnosis.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-09-2020 11:00:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-09-2020 11:00:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-09-2020 11:00:10
(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
Nov-09-2020 11:00:10
(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
Nov-09-2020 11:00:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943829
Page 157 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Nov-09-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-09-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-09-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Blurred VisionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-09-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 UNK:UNKInitial Entry
5  Is the adverse event still ongoing?
Date Location User Value Reason
Nov-09-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/31/2020 UNK:UNKInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943830
Page 158 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
6. Toxicity Grade:
Date Location User Value Reason
Nov-09-2020 11:01:28
(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
Nov-09-2020 11:01:28
(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
Nov-09-2020 11:01:28
(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
Nov-09-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
Subject instructed to seek
out care from PCP to getInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943831
Page 159 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
accurate diagnosis.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-09-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-09-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-09-2020 11:01:28
(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
Nov-09-2020 11:01:28
(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
Nov-09-2020 11:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943832
Page 160 of 207
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Nov-09-2020 11:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-09-2020 11:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-12-2020 08:54:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-12-2020 08:44:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Confirmed. It is
not considered an
SAE.
Nov-11-2020 09:36:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened clinical: pls
confirm PI does
not consider event
IME/SAE. Thanks
Nov-09-2020 11:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SyncopeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-09-2020 11:02:30
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Oct/1/2020 UNK:UNKInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943833
Page 161 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-09-2020 11:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/1/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-09-2020 11:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-10-2020 12:39:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Nov-10-2020 11:57:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Nov-10-2020 11:57:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
Nov-10-2020 11:38:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
complete this
section. If this is a
SAE, please
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943834
Page 162 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
submit a SAE
report ASAP.
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
Nov-09-2020 11:02:30
(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
Nov-10-2020 12:39:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Nov-10-2020 11:58:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Nov-10-2020 11:58:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
Subject was advised to s
eek care from PCP to get
accurate diagnosis.New Information
Nov-10-2020 11:41:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify if this AE
occurred around
the same time with
the other 3 AEs
with onset of
10/1/20. IF yes,
please elaborate on
the consideration
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943835
Page 163 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
of this AE being
drug related but the
other 3 being not
related.
Nov-09-2020 11:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-09-2020 11:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-09-2020 11:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-09-2020 11:02:30
(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
Nov-09-2020 11:02:30
(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
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943836
Page 164 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-09-2020 11:02:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943837
Page 165 of 207
***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, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Jan-27-2021 16:12:51
(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-27-2021 16:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-04-2021 05:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Feb-24-2021 13:53:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered SAE follow up
form with
cardiologist follow
up was already
sent/faxed on
02Feb2021.
Feb-09-2021 14:03:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Thanks for
confirming. Please
make every effort
possible to obtain
further details and
respond once Med
records are
available.
Feb-01-2021 14:15:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Will provide
information when
medical records
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943838
Page 166 of 207
***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, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
arrive at our site.
We have requested
them.
Feb-01-2021 07:23:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened CLNICAL_ Per
report submitted to
safety, the subject
was hospitalized
and was evaluated
by cardiologist. Pls
provide
information of
workup performed
(relevant test) and
clinical evolution
during hospital
stay in a FU form.
Thanks.
Jan-27-2021 16:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Newly Diagnosed Coronary
Artery DiseaseInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-08-2021 08:41:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-04-2021 15:01:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-04-2021 15:01:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 UNK:UNKNew Information
Feb-04-2021 11:55:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2021082332
,the Onset Date was
reported as
01-OCT-2020 in
Safety database but
in InFORM the Start
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943839
Page 167 of 207
***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, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
date 16/DEC/2020.
Dates are to match
therefore please
update INFORM or
submit a follow-up
safety report to
update Safety.
Jan-27-2021 16:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-27-2021 16:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/17/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-29-2021 09:59:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Transcription Error
Jan-27-2021 16:12:51
(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
Feb-01-2021 09:24:19
(UTC-06:00) CentralACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943840
Page 168 of 207
***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, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
Jan-27-2021 16:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Newly
Diagnosed
Coronary Artery
Disease: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Jan-27-2021 16:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requir
e or prolong hospitalization?
YES
Did this serious event result
in persistent or significant di
sability/incapacity?
NO
Is this serious event life thre
atening?
NO
Other medically important s
erious event
YESInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943841
Page 169 of 207
***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, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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-27-2021 16:12:51
(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-27-2021 16:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
Hyperlipidemia, Hyperte
nsion, and ObesityInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-27-2021 16:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-27-2021 16:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943842
Page 170 of 207
***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, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-27-2021 16:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-27-2021 16:12:51
(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-27-2021 16:12:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-01-2021 09:24:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021082332Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943843
Page 171 of 207
***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, Deleted
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Jan-27-2021 16:15:27
(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-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-04-2021 08:00:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Feb-02-2021 08:25:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered In the process of
contacting help
desk because we
have tried multiple
times to delete this
AE.
Feb-01-2021 21:22:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Reissued:Opened GPDClin: Per our
data manager,
please refer to
section 4.11 of
CRF completion
guidelines, that
should help with
the deletion.
Feb-01-2021 08:37:57 ACV0PFEINFP6000  Query 1: Answered Having issues
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943844
Page 172 of 207
***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, Deleted
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-06:00) Central
Time (US & Canada)removing this AE.
EDC won't allow
me. Will try again
Jan-31-2021 10:31:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened AE to be removed
from EDC.
Jan-29-2021 09:40:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered will remove AE
Jan-28-2021 14:28:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Per
protocol 10.3.1,
Medical or
surgical procedure
should not be an
AE, the condition
that leads to the
procedure is the
AE. As CAD is
reported
separately as a
SAE, please
remove this
procedure item
from the AE log.
Jan-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Placement of Coronary Arteri
al Stent in Left Circumflex Co
ronary ArteryInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-27-2021 16:15:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-27-2021 16:15:41
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Dec/16/2020 UNK:UNKTranscription Error
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943845
Page 173 of 207
***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, Deleted
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada)
Jan-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For Placement of
Coronary Arterial
Stent in Left
Circumflex
Coronary Artery
Start Date 16/Dec
/2021, is a future
date relative to
when it was
entered on 27/Jan
/2021. Please
correct.
Jan-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-27-2021 16:15:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For Placement of
Coronary Arterial
Stent in Left
Circumflex
Coronary Artery
End Date & Time
17/Dec/2020
UNK:UNK is
before the Start
Date & Time
16/Dec/2021
UNK:UNK.
Jan-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943846
Page 174 of 207
***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, Deleted
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Dec/17/2020 UNK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Jan-27-2021 16:15:27
(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
Feb-04-2021 11:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed AE deleted
Feb-02-2021 08:06:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-02-2021 08:06:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Feb-01-2021 13:09:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered INFORM/EDC will
not allow me to
remove AE. I have
tried to delete
multiple times but
system won't let
me.
Feb-01-2021 12:39:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened SAE RECON:
Placement of
Coronary Arterial
Stent in Left
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943847
Page 175 of 207
***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, Deleted
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Circumflex
Coronary Artery is
not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade event
on CRF
Feb-01-2021 10:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE Placement
of Coronary
Arterial Stent in
Left Circumflex
Coronary Artery:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Feb-01-2021 09:30:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query is invalid or
does not apply
Jan-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Placement
of Coronary
Arterial Stent in
Left Circumflex
Coronary Artery:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Jan-27-2021 16:15:27
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943848
Page 176 of 207
***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, Deleted
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada) Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
YES
Did this serious event result
in persistent or significant d
isability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important s
erious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943849
Page 177 of 207
***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, Deleted
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Jan-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
Related to Coronary Art
ery DiseaseInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-27-2021 16:15:27
(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-27-2021 16:15:27
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943850
Page 178 of 207
***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, Deleted
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada)
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-27-2021 16:15:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-01-2021 10:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-01-2021 10:07:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021082332Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943851
Page 179 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Feb-03-2021 15:43:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-03-2021 15:43:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-15-2021 07:06:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 3: Closed Response satisfies
query
Feb-09-2021 08:18:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Thank you
Feb-08-2021 15:59:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 4: Closed Response satisfies
query
Feb-08-2021 15:58:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 3: Reissued:Opened Clin: A protocol
deviation will be
documented. Thank
you.
Feb-08-2021 08:44:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Per previous query,
shortness of breath
was a previous
symptom of
coronary artery
disease, not
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943852
Page 180 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
COVID related.
Feb-08-2021 08:43:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Per previous query,
shortness of breath
was a previous
symptom of
coronary artery
disease, not
COVID related.
Feb-07-2021 22:13:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 4: Opened Clin: Despite
telehealth visit was
not done, please
complete the
potential
COVID-19 Illness
Visit CRF forms
with all
information
available. Should
be captured only on
the SOD CRF form
and a NASAL
SWAB will not be
collected
Feb-07-2021 22:12:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 3: Opened Clin: Per Prot Sect
8.1., COVID-19
listed symptom
SHORTNESS OF
BREATH should
have please
triggered a
potential COVID
Illness Visit
irrespective of
perceived etiology
or clinical
significance and
captured only on
the CRF SOD form
Feb-07-2021 20:22:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 2: Closed Response satisfies
query
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943853
Page 181 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-05-2021 13:36:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Yes related to
CAD.
Feb-04-2021 07:59:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 2: Opened This AE occurred
simultaneously
with other AEs
(symptoms), i.e.,
syncope, blurred
vision, dizziness.
Were those AEs
related to the later
diagnosed CAD?
Feb-04-2021 07:57:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Modified query.
Feb-04-2021 07:52:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: This AE
occurred
simultaneously
with other AEs,
syncope, blurred
vision, dizziness,
has any workup
been done or any
diagnosis was
made?
Feb-03-2021 15:43:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Shortness of BreathInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-03-2021 15:43:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943854
Page 182 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-03-2021 15:43:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/17/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-03-2021 15:43:46
(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
Feb-03-2021 15:43:46
(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
Feb-03-2021 15:43:46
(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
Feb-04-2021 14:26:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:New Information
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943855
Page 183 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
OTHER
If Other, specify:
Coronary Artery Diseas
e
Feb-03-2021 15:43:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-03-2021 15:43:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-04-2021 14:26:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-04-2021 14:26:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-03-2021 15:43:46
(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?
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943856
Page 184 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Feb-03-2021 15:43:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943857
Page 185 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Mar-01-2021 11:12:15
(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-01-2021 11:12:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-01-2021 11:12:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Pain at injection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-01-2021 11:12:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/28/2021 UNK:UNKInitial Entry
5  Is the adverse event still ongoing?
Date Location User Value Reason
Mar-01-2021 11:12:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/29/2021 UNK:UNKInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943858
Page 186 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
6. Toxicity Grade:
Date Location User Value Reason
Mar-01-2021 11:12:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-01-2021 11:12:15
(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-01-2021 11:12:15
(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-01-2021 11:12:15
(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-01-2021 11:12:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0943859
Page 187 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-01-2021 11:12:15
(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-01-2021 11:12:15
(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-01-2021 11:12:15
(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-01-2021 11:12:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943860
Page 188 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021 09:22:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-28-2021 09:22:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/30/2020Transcription Error
Jan-28-2021 09:19:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of Visit,
30/Dec/2021 is a
future date relative
to when it was
entered on 28/Jan
/2021. Please
correct.
Jan-28-2021 09:19:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/30/2021Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943861
Page 189 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-28-2021 09:22:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 09:19:54
(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.
Jan-28-2021 09:19:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to retur
n for Vaccination 3
Participant is:
eligible per local/national
recommendations and co
nfirmed to have received
only placebo at Vaccinati
on 1/2Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943862
Page 190 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-28-2021 09:22:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-28-2021 09:22:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943863
Page 191 of 207
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Jan-28-2021 09:22:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943864
Page 192 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-28-2021 09:20:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943865
Page 193 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-28-2021 09:20:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Jan/27/2021Initial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943866
Page 194 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-28-2021 09:20:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-28-2021 09:20:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-28-2021 09:20:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943867
Page 195 of 207
***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: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701090 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-28-2021 09:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-28-2021 09:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-28-2021 09:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-28-2021 09:27:27
(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-28-2021 09:27:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/27/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3f8b\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943868
Page 196 of 207
***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
…[truncated]