Document text
Page 1 of 191
***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: 11701121 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
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943881
Page 2 of 191
***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: 11701121 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/28/2020
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943882
Page 3 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11701121]
2.Birth Date: 1970
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): ASIAN
6.Racial Designation:
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943883
Page 4 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943884
Page 5 of 191
***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: 11701121 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
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943885
Page 6 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943886
Page 7 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943887
Page 8 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [84.6]
3.Unit: kg
4.Height: [160.02]
5.Unit: cm
6.Body Mass Index: [33.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943888
Page 9 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/28/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943889
Page 10 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [71930]
3.Randomization Group: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943890
Page 11 of 191
***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: 11701121 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/28/2020
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 [BNW71R]
5.bSample ID [BNW71S]
5.cSample ID [BPYHXP]
5.dSample ID [BPYHXR]
5.eSample ID [BPYHXS]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943891
Page 12 of 191
***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: 11701121 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/28/2020
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 [BPYHXM]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943892
Page 13 of 191
***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: 11701121 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/28/2020 11:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943893
Page 14 of 191
***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: 11701121 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
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943894
Page 15 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943895
Page 16 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943896
Page 17 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/18/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943897
Page 18 of 191
***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: 11701121 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/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BGJKNJ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943898
Page 19 of 191
***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: 11701121 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/18/2020 12:20
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943899
Page 20 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943900
Page 21 of 191
***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: 11701121 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/20/2020
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 [BRX8TX]
5.bSample ID [BRX8TY]
5.cSample ID [BGK0G5]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943901
Page 22 of 191
***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: 11701121 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:
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943902
Page 23 of 191
***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: 11701121 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: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943903
Page 24 of 191
***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: 11701121 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 [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943904
Page 25 of 191
***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: 11701121 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 [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943905
Page 26 of 191
***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: 11701121 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?
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943906
Page 27 of 191
***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: 11701121 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:
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943907
Page 28 of 191
***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: 11701121 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:
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943908
Page 29 of 191
***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: 11701121 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 [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943909
Page 30 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943910
Page 31 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943911
Page 32 of 191
***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: 11701121 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/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943912
Page 33 of 191
***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: 11701121 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: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943913
Page 34 of 191
***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: 11701121 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:
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943914
Page 35 of 191
***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: 11701121 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 [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943915
Page 36 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 Headache Sep/18/2020 UN
K:UNK NO
End Date Time:
Sep/18/2020 UNK:UN
K
Repeating
Pages
2.ADVERSE E
VENT 2 Headache Jan/21/2021 UNK
:UNK NO
End Date Time:
Jan/22/2021 UNK:UN
K
Repeating
Pages
3.ADVERSE E
VENT 3 Injection Site Pain Jan/21/2021 UNK
:UNK NO
End Date Time:
Jan/22/2021 UNK:UN
K
Repeating
Pages
4.ADVERSE E
VENT 4 Myalgias Jan/21/2021 UNK
:UNK NO
End Date Time:
Jan/22/2021 UNK:UN
K
Repeating
Pages
5.ADVERSE E
VENT 5 Right Lower Extremity
Fracture Jan/22/2021 UNK
:UNK YES Repeating
Pages
6.ADVERSE E
VENT 6 Fall Jan/22/2021 UNK
:UNK NO
End Date Time:
Jan/22/2021 UNK:UN
K
Repeating
Pages
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943916
Page 37 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 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)[Headache]
4.Start Date Time: Sep/18/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/18/2020 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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943917
Page 38 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943918
Page 39 of 191
***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: 11701121 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)[Headache]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943919
Page 40 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943920
Page 41 of 191
***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: 11701121 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)[Injection Site Pain]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943921
Page 42 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943922
Page 43 of 191
***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: 11701121 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)[Myalgias]
4.Start Date Time: Jan/21/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 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
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943923
Page 44 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943924
Page 45 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 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)[Right Lower Extremity Fracture]
4.Start Date Time: Jan/22/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943925
Page 46 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 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:
[Injury is from a fall]
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?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021072908]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943926
Page 47 of 191
***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: 11701121 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)[Fall]
4.Start Date Time: Jan/22/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[subject tripped over dog gate - mechanical fall]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943927
Page 48 of 191
***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: 11701121 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[ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943928
Page 49 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943929
Page 50 of 191
***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: 11701121 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[ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943930
Page 51 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
1.1 VACCINATIONS NO Influenza Vacci
ne Oct/6/20
20 Repeating
Pages
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943931
Page 52 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[Influenza Vaccine]
5.Date: Oct/6/2020
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943932
Page 53 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943933
Page 54 of 191
***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: 11701121 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?
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943934
Page 55 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943935
Page 56 of 191
***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: 11701121 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?
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943936
Page 57 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943937
Page 58 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943938
Page 59 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943939
Page 60 of 191
***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: 11701121 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:
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943940
Page 61 of 191
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943941
Page 62 of 191
***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: 11701121 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?
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943942
Page 63 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943943
Page 64 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943944
Page 65 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/22/2020
2.Erroneous Visit
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943945
Page 66 of 191
***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: 11701121 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
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943946
Page 67 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943947
Page 68 of 191
***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: 11701121 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
Dec/28/2020
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943948
Page 69 of 191
***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: 11701121 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
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943949
Page 70 of 191
***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: 11701121 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
:Dec/28/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943950
Page 71 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Dec/28/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943951
Page 72 of 191
***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: 11701121 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:
Dec/28/2020
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 [BPS9J9]
5.bSample ID [BRTWDY]
5.cSample ID [BRTWDZ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943952
Page 73 of 191
***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: 11701121 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:
Dec/28/2020
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 [BPS9J8]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943953
Page 74 of 191
***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: 11701121 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: Dec/28/2020 10:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943954
Page 75 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/22/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943955
Page 76 of 191
***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: 11701121 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
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943956
Page 77 of 191
***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: 11701121 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: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943957
Page 78 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943958
Page 79 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/20/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943959
Page 80 of 191
***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: 11701121 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/20/2021
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 [BPSBY1]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943960
Page 81 of 191
***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: 11701121 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/20/2021 11:02
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943961
Page 82 of 191
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943962
Page 83 of 191
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/17/2021
3.Comments: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943963
Page 84 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943964
Page 85 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943965
Page 86 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943966
Page 87 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943967
Page 88 of 191
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/17/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943968
Page 89 of 191
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 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/20/2020
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943969
Page 90 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 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
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943970
Page 91 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 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 12:09:35 (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.
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943971
Page 92 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-28-2020 11:55:00 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943972
Page 93 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-28-2020 11:55:32 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943973
Page 94 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-28-2020 13:52:30 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943974
Page 95 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormDec-28-2020 13:57:25 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943975
Page 96 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Dec-28-2020 13:57:25 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943976
Page 97 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 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 12:09:35 (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-25-2021 16:01:59 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mezgebe Berhe Approved Jan-22-2021 16:35:15 (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-22-2021 14:47:04 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943977
Page 98 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Mezgebe Berhe Approved Jan-21-2021 15:31:49 (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 Dec-28-2020 13:51:16 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mezgebe Berhe Approved Oct-30-2020 09:57:59 (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.
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943978
Page 99 of 191
***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: 11701121 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-28-2020 11:53:58
(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-28-2020 11:53:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943979
Page 100 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020 11:54:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/28/2020Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943980
Page 101 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020 11:53:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11701121Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020 11:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1970Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020 11:54:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-28-2020 11:54:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020 11:54:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASIANInitial Entry
090177e196ae3f8a\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-2021-5683-0943981
Page 102 of 191
***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: 11701121 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-28-2020 11:54:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943982
Page 103 of 191
***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: 11701121 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-28-2020 11:55:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020 11:55:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020 11:55:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943983
Page 104 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 11:56:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020 11:56:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
84.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020 11:56:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-28-2020 11:56:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
160.02Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020 11:56:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020 11:56:04
(UTC-06:00) CentralACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
33.0Initial Entry
090177e196ae3f8a\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-2021-5683-0943984
Page 105 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-28-2020 11:56:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.9
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 11:56:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020 11:56:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020 11:56:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 11:56:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3f8a\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-2021-5683-0943985
Page 106 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-28-2020 11:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-28-2020 11:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-28-2020 11:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-28-2020 11:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-28-2020 11:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943986
Page 107 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-28-2020 11:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-28-2020 11:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-28-2020 11:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-28-2020 11:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943987
Page 108 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020 11:56:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020 11:56:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
71930Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943988
Page 109 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 11:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 11:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020 13:59:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 11:56:48
(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-28-2020 11:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 13:59:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNW71RInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943989
Page 110 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 13:59:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNW71RInitial Entry
5.b
Date Location User Value Reason
Aug-28-2020 13:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BNW71SInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020 13:59:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BNW71SInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020 14:00:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYHXPInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020 14:00:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYHXPInitial Entry
5.d
Date Location User Value Reason
Aug-28-2020 14:00:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYHXRInitial Entry
090177e196ae3f8a\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-2021-5683-0943990
Page 111 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User Value Reason
Aug-28-2020 14:00:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYHXRInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020 14:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYHXSInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-28-2020 14:00:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYHXSInitial Entry
090177e196ae3f8a\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-2021-5683-0943991
Page 112 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 11:56:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 11:56:54
(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-28-2020 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 11:56:54
(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-28-2020 11:56:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPYHXMInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943992
Page 113 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Aug-28-2020 14:00:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPYHXMInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943993
Page 114 of 191
***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: 11701121 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-28-2020 11:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 11:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 11:57:40
(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-28-2020 11:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/28/2020 11:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 11:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020 11:57:40
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3f8a\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-2021-5683-0943994
Page 115 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-28-2020 11:57:40
(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-28-2020 11:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-28-2020 11:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0943995
Page 116 of 191
***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: 11701121 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 10:03:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Sep-03-2020 10:03:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTTranscription Error
Sep-03-2020 04:27:31
(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-28-2020 11:57:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E
-DIARY COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3f8a\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-2021-5683-0943996
Page 117 of 191
***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: 11701121 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-18-2020 13:44:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943997
Page 118 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020 13:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
2.a
Date Location User Value Reason
Sep-18-2020 13:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.3
Temperature Unit: F
Temperature Loca
tion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-18-2020 13:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-18-2020 13:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-18-2020 13:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3f8a\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-2021-5683-0943998
Page 119 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Sep-18-2020 13:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943999
Page 120 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020 13:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020 13:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020 13:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-18-2020 13:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020 13:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944000
Page 121 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-18-2020 13:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-18-2020 13:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020 13:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020 13:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944001
Page 122 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020 13:45:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020 13:45:00
(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-18-2020 15:51:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-18-2020 13:45:00
(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-18-2020 13:45:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020 15:52:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BGJKNJTranscription Error
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944002
Page 123 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-18-2020 15:51:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BGJKNJMInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020 15:52:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-18-2020 15:52:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BGJKNJTranscription Error
Sep-18-2020 15:51:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in length.
Please review and
correct as
appropriate.
Sep-18-2020 15:51:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BGJKNJMInitial Entry
090177e196ae3f8a\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-2021-5683-0944003
Page 124 of 191
***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: 11701121 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-18-2020 13:45:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020 13:45:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020 13:45:42
(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-18-2020 13:45:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020 12:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020 13:45:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-18-2020 13:45:42
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3f8a\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-2021-5683-0944004
Page 125 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-18-2020 13:45:42
(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-18-2020 13:45:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-18-2020 13:45:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944005
Page 126 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-20-2020 11:47:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944006
Page 127 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 13:36:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 13:36:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 13:37:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-20-2020 13:36:53
(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-20-2020 13:36:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-20-2020 13:37:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRX8TXInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944007
Page 128 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 13:37:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRX8TXInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020 13:37:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRX8TYInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 13:37:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRX8TYInitial Entry
5.c
Date Location User Value Reason
Oct-20-2020 13:37:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BGK0G5Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 13:37:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BGK0G5Initial Entry
090177e196ae3f8a\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-2021-5683-0944008
Page 129 of 191
***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: 11701121 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-20-2020 11:47:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020 11:47:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020 11:47:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944009
Page 130 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-28-2020 10:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944010
Page 131 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Jan-22-2021 14:47:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944011
Page 132 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Jan-22-2021 14:47:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944012
Page 133 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Jan-22-2021 14:50:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944013
Page 134 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Jan-25-2021 16:01:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944014
Page 135 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Feb-02-2021 14:32:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944015
Page 136 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 10:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-28-2020 10:31:01
(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
Oct-28-2020 10:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 12:11:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-28-2020 10:34:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Time unknown.
However, subject
reported symptom
after injection.
Oct-28-2020 10:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE Headache :
Start Date is the
same as a
Vaccination Date,
but time is not
provided. Please
review and update
as appropriate.
090177e196ae3f8a\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-2021-5683-0944016
Page 137 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-28-2020 10:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/18/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-28-2020 10:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/18/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-28-2020 10:31:01
(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
Oct-28-2020 10:31:01
(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
Oct-28-2020 10:31:01
(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
090177e196ae3f8a\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-2021-5683-0944017
Page 138 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-30-2020 11:05:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-30-2020 08:53:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Oct-30-2020 08:53:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
Oct-30-2020 00:20:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please
complete this item.
Thank you.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 10:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-28-2020 10:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 10:31:01
(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
Oct-28-2020 10:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae3f8a\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),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944018
Page 139 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-28-2020 10:31:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944019
Page 140 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Jan-22-2021 14:47:04
(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-22-2021 14:47:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-22-2021 14:47:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021 14:47:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/21/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-22-2021 14:47:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/22/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3f8a\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-2021-5683-0944020
Page 141 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-22-2021 14:47:04
(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
Jan-22-2021 14:47:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-22-2021 14:47:04
(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-22-2021 14:47:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-22-2021 14:47:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3f8a\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-2021-5683-0944021
Page 142 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-22-2021 14:47:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-22-2021 14:47:04
(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-22-2021 14:47:04
(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-22-2021 14:47:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f8a\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-2021-5683-0944022
Page 143 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Jan-22-2021 14:47:39
(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-22-2021 14:47:39
(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
Jan-22-2021 14:47:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site PainInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021 14:47:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/21/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-22-2021 14:47:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/22/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3f8a\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-2021-5683-0944023
Page 144 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-22-2021 14:47:39
(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
Jan-22-2021 14:47:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-22-2021 14:47:39
(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-22-2021 14:47:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-22-2021 14:47:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3f8a\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-2021-5683-0944024
Page 145 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-22-2021 14:47:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-22-2021 14:47:39
(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-22-2021 14:47:39
(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-22-2021 14:47:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f8a\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-2021-5683-0944025
Page 146 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Jan-22-2021 14:50:00
(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-22-2021 14:50:00
(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
Jan-22-2021 14:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MyalgiasInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021 14:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/21/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-22-2021 14:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/22/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3f8a\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-2021-5683-0944026
Page 147 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-22-2021 14:50:00
(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
Jan-22-2021 14:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-22-2021 14:50:00
(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-22-2021 14:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-22-2021 14:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3f8a\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-2021-5683-0944027
Page 148 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-22-2021 14:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-22-2021 14:50:00
(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-22-2021 14:50:00
(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-22-2021 14:50:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f8a\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-2021-5683-0944028
Page 149 of 191
***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
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Jan-25-2021 16:01:59
(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-25-2021 16:01:59
(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
Mar-04-2021 09:56:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Thanks. Closing
query to FU at a
later date.
Mar-01-2021 09:30:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered We are told queries
are be answered
within a day. We
have requested
medical records but
site still hasn't
received them. Will
provide information
when medical
records arrive at our
site.
Feb-09-2021 14:02:24
(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.
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944029
Page 150 of 191
***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
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-01-2021 14:15:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Will provide
information when
medical records
arrive at our site.
We have requested
them.
Feb-01-2021 07:04:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened CLINICAL_ Pls
provide further
information on
relevant imaging
test, final diagnosis
and evolution
during hospital stay.
Thanks.
Jan-25-2021 16:01:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Right Lower Extremity FractureInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-25-2021 16:01:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-25-2021 16:01:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-10-2021 00:33:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-27-2021 15:25:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidate Site waiting on
medical records,
please review
response on #12
090177e196ae3f8a\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)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944030
Page 151 of 191
***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
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
once completed.
Jan-27-2021 10:25:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
Jan-27-2021 09:56:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Waiting on medical
records to arrive in
order to answer #6
and #12
Jan-27-2021 01:32:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please
complete item # 6
and 12. Thank you.
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-26-2021 09:03:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-25-2021 16:01:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Right
Lower Extremity
Fracture: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Jan-25-2021 16:01:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?Initial Entry
090177e196ae3f8a\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-2021-5683-0944031
Page 152 of 191
***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
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
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.
Date Location User Value Reason
Jan-25-2021 16:01:59
(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-02-2021
17:04:00
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
ClosedResponse
satisfies query
Feb-02-2021
14:38:40
(UTC-06:00)ACV0PFEINFP6000 Query 2:
AnsweredAe created for
the fall
090177e196ae3f8a\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-2021-5683-0944032
Page 153 of 191
***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
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Central Time
(US &
Canada)
Feb-02-2021
11:05:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
Reissued:
OpenedClinQuery2:
Thanks for
responding.
Since this
injury is due to
a fall, please
enter a new
separate AE for
the fall.
Feb-02-2021
08:02:17
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2:
AnsweredTranscription
Error
Feb-02-2021
08:02:17
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
NOT RE
LATED
If Not R
elated to
study tre
atment(s
), this ev
ent is du
e to:
OTHE
R
If Ot
her, s
pecif
y:
Inju
ry i
s fr
om
a fa
llTranscription
Error
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944033
Page 154 of 191
***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
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-01-2021
16:13:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 2:
OpenedClinQuery:
Causality is
noted as Injury,
which does not
explain the
mostly cause of
the Fracture.
Please verify
causality and
review CCG
8.50.2.1 and
8.50.2.2 and
confirm if
additional AEs
need to be
entered if the
Injury is from
MVA or fall.
Jan-26-2021
14:00:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse
satisfies query
Jan-26-2021
11:29:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredTranscription
Error
Jan-26-2021
11:29:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data Ent
ry:
NOT RE
LATED
If Not R
elated to
study tre
atment(s
), this ev
ent is du
e to:
OTHE
RTranscription
Error
090177e196ae3f8a\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-2021-5683-0944034
Page 155 of 191
***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
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
If Ot
her, s
pecif
y:
Inju
ry t
hat
is n
ot a
sso
ciat
ed
wit
h st
udy
trea
tme
nt.
Jan-26-2021
10:41:21
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1:
OpenedPlease review
"If not related
to study
treatment
other" field, the
following text
was indicated
in the comment
field [ae]. Any
symptoms, AEs
or other key
data should be
collected on the
appropriate
page. Please
review and
update as
necessary.
"
]"
Jan-25-2021
16:01:59
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000 Data Ent
ry:
NOT RE
LATED
If Not RInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0944035
Page 156 of 191
***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
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Canada) elated to
study tre
atment(s
), this ev
ent is du
e to:
OTHE
R
If Ot
her, s
pecif
y:
Inju
ry t
hat
is n
ot a
sso
ciat
ed
wit
h a
ny
AE
of s
tud
y tr
eat
me
nt.
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-25-2021 16:01:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944036
Page 157 of 191
***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
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-25-2021 16:01:59
(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-09-2021 11:19:21
(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-25-2021 16:01:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-25-2021 16:01:59
(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
Jan-26-2021 09:03:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021072908Initial Entry
090177e196ae3f8a\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-2021-5683-0944037
Page 158 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Feb-02-2021 14:32:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-02-2021 14:32:28
(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
Feb-02-2021 14:32:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FallInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-02-2021 14:32:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-02-2021 14:32:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/22/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3f8a\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-2021-5683-0944038
Page 159 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-02-2021 14:32:28
(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
Feb-02-2021 14:32:28
(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
Feb-02-2021 14:32:28
(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
Feb-02-2021 14:32:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
subject tripped over dog gat
e - mechanical fallInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3f8a\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-2021-5683-0944039
Page 160 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-02-2021 14:32:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-02-2021 14:32:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-02-2021 14:32:28
(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
Feb-02-2021 14:32:28
(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
Feb-02-2021 14:32:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f8a\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-2021-5683-0944040
Page 161 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-20-2020 11:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944041
Page 162 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - 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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-20-2020 11:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-20-2020 11:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-20-2020 11:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Oct-20-2020 11:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Influenza VaccineInitial Entry
5. Date:
Date Location User Value Reason
Oct-20-2020 11:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/6/2020Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944042
Page 163 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-28-2020 13:51:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/22/2020Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944043
Page 164 of 191
***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: 11701121 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
Dec-28-2020 13:57:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-28-2020 13:52:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Dec-28-2020 13:52:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national re
commendations and confirm
ed to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944044
Page 165 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-28-2020 13:52:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/28/2020Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944045
Page 166 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-28-2020 13:52:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Dec/28/2020Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944046
Page 167 of 191
***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: 11701121 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
Dec-28-2020 13:52:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-28-2020 13:52:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-28-2020 13:52:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944047
Page 168 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-28-2020 13:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-28-2020 13:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-28-2020 13:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/28/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-28-2020 13:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-28-2020 13:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944048
Page 169 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Dec-28-2020 13:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-28-2020 13:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Dec-28-2020 13:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Dec-28-2020 13:53:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944049
Page 170 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-28-2020 13:53:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-28-2020 13:53:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-28-2020 13:53:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-28-2020 13:53:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-28-2020 13:53:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/28/2020Initial Entry
5.a
Date Location User Value Reason
Dec-28-2020 13:53:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPS9J9Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944050
Page 171 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Dec-28-2020 13:53:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPS9J9Initial Entry
5.b
Date Location User Value Reason
Dec-28-2020 13:53:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRTWDYInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-28-2020 13:53:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRTWDYInitial Entry
5.c
Date Location User Value Reason
Dec-28-2020 13:53:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRTWDZInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-28-2020 13:53:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRTWDZInitial Entry
090177e196ae3f8a\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-2021-5683-0944051
Page 172 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-28-2020 13:54:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-28-2020 13:54:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-28-2020 13:54:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-28-2020 13:54:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-28-2020 13:54:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/28/2020Initial Entry
5.a
Date Location User Value Reason
Dec-28-2020 13:54:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPS9J8Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944052
Page 173 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Dec-28-2020 13:54:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPS9J8Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944053
Page 174 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 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
Dec-28-2020 13:57:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-28-2020 13:57:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-28-2020 13:57:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-28-2020 13:57:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/28/2020 10:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-28-2020 13:57:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-28-2020 13:57:00
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3f8a\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-2021-5683-0944054
Page 175 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Dec-28-2020 13:57:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-28-2020 13:57:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-28-2020 13:57:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-28-2020 13:57:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-11-2021 09:51:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-08-2021 13:52:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Source has been
corrected. Subject
was observed for
30 minutes, end
090177e196ae3f8a\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-2021-5683-0944055
Page 176 of 191
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
time is 11:08.
Jan-07-2021 10:45:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Source states
subject was
assessed for 24
minutes not 30
minutes, please
confirm. 10:38 to
11:02 is 24
minutes.
Dec-28-2020 13:57:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0944056
Page 177 of 191
***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: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-28-2020 13:57:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/22/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-28-2020 13:57:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944057
Page 178 of 191
***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: 11701121 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
Dec-28-2020 13:57:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944058
Page 179 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 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-20-2021 14:04:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/20/2021Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944059
Page 180 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-20-2021 14:05:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-20-2021 14:05:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-20-2021 14:05:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/20/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-20-2021 14:05:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-20-2021 14:05:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944060
Page 181 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-20-2021 14:05:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-20-2021 14:05:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-20-2021 14:05:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Jan-20-2021 14:05:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944061
Page 182 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-20-2021 15:04:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-20-2021 15:04:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-20-2021 15:04:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-20-2021 15:04:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-20-2021 15:04:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Jan/20/2021Initial Entry
5.a
Date Location User Value Reason
Jan-20-2021 15:04:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPSBY1Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944062
Page 183 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Jan-20-2021 15:04:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPSBY1Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944063
Page 184 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 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
Jan-20-2021 14:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-20-2021 14:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-20-2021 14:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-20-2021 14:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/20/2021 11:02Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-20-2021 14:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-20-2021 14:05:57
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3f8a\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-2021-5683-0944064
Page 185 of 191
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-20-2021 14:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-20-2021 14:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-20-2021 14:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-20-2021 14:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-20-2021 14:05:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944065
Page 186 of 191
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-19-2021 11:20:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/17/2021Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944066
Page 187 of 191
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-19-2021 11:21:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-19-2021 11:21:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Feb/17/2021Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944067
Page 188 of 191
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Feb-22-2021
04:15:44
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies
query
Feb-19-2021
15:26:54
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dCorrect as is. Subject
had V103MTH1
TELEvisit after both
unblinded
vaccinations, so that
is the date that was
entered. 2/17 -
V103MTH1 televisit
EOT2- 2/17. Was
queried and told to
fill out EOT2 after
V103MTH1 was
completed.
Feb-19-2021
15:00:05
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7322759;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Feb-19-2021
11:26:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Feb/1
7/202
1Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
090177e196ae3f8a\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)
FDA-CBER-2021-5683-0944068
Page 189 of 191
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-19-2021 11:26:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Feb-19-2021 11:26:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0944069
Page 190 of 191
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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1. Subject Status
Date Location User Value Reason
Oct-20-2020 11:47:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-28-2020 11:56:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-28-2020 11:55:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-20-2020 11:47:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
Aug-28-2020 11:56:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
Aug-28-2020 11:55:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0944070
Page 191 of 191
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1170 Site Name: (1170) North Texas Infectious Diseases Consultants, P.A.
Subject No: 11701121 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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1. Casebook Signature
Date Location User Value Reason
Oct-30-2020 09:16:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f8a\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0944071