125742 S1 M5 CRF c4591001 1221 12211007

Document text

Page 1 of 178
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826130
Page 2 of 178
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/15/2020
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826131
Page 3 of 178
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12211007]
2.Birth Date: 1983
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): AMERICAN INDIAN OR ALASKA NATIVE
6.Racial Designation:
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0826132
Page 4 of 178
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826133
Page 5 of 178
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826134
Page 6 of 178
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826135
Page 7 of 178
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Seasonal allergies]
Start Date: UNK/UNK/2012
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Uveitis]
Start Date: Jan/UNK/2006
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Chronic intermittent back pain]
Start Date: UNK/UNK/2012
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Foot fracture]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
Jun/UNK/2014
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Syphilis]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826136
Page 8 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Syphilis]
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
Mar/10/2020
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety]
Start Date: Jun/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2018
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Surgical revision of scar tissue in foot]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
Jun/UNK/2014
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826137
Page 9 of 178
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
2.Weight: [118.4]
3.Unit: kg
4.Height: [180.0]
5.Unit: cm
6.Body Mass Index: [36.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826138
Page 10 of 178
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/16/2020
2.Randomization Number: [109338]
3.Randomization Group: [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826139
Page 11 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8BPD]
5.bSample ID [BS71YW]
5.cSample ID [BS71YX]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826140
Page 12 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8BPC]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826141
Page 13 of 178
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/16/2020 15:56
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
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826142
Page 14 of 178
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826143
Page 15 of 178
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/7/2020 Comments
2.Erroneous Visit
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826144
Page 16 of 178
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Dec/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826145
Page 17 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/7/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8BXJ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826146
Page 18 of 178
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: Dec/7/2020 13:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826147
Page 19 of 178
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826148
Page 20 of 178
***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, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826149
Page 21 of 178
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826150
Page 22 of 178
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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: [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826151
Page 23 of 178
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826152
Page 24 of 178
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826153
Page 25 of 178
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826154
Page 26 of 178
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826155
Page 27 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826156
Page 28 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826157
Page 29 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826158
Page 30 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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 [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826159
Page 31 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  Abscess in left jaw  Oct/31/2020 U
NK:UNK NO
End Date Time:
Dec/2/2020 UNK:U
NK
 Repeating
Pages
 2. ADVERSE
EVENT 2  Meningitis Bacterial  Nov/10/2020 U
NK:UNK NO
End Date Time:
Dec/2/2020 UNK:U
NK
 Repeating
Pages
 3. DELETED ADVERSE
EVENT 3  Pain radiating from left temple/jaw
to neck and shoulder Oct/27/2020 U
NK:UNK YES  Repeating
Pages
 4. ADVERSE
EVENT 4  STD Exposure  Nov/6/2020 UN
K:UNK NO
End Date Time:
Nov/6/2020 UNK:U
NK
 Repeating
Pages
 5. ADVERSE
EVENT 5  Left Otitis Externa  Nov/6/2020 UN
K:UNK NO
End Date Time:
Nov/18/2020 UNK:
UNK
 Repeating
Pages
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826160
Page 32 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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)[Abscess in left jaw]
4.Start Date Time: Oct/31/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/2/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Inflammation vs. infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826161
Page 33 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826162
Page 34 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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)[Meningitis Bacterial]
4.Start Date Time: Nov/10/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/2/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
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
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:
[Bacterial infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826163
Page 35 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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[2020449668]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826164
Page 36 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Pain radiating from left temple/jaw to neck and shoulder ]
4.Start Date Time: Oct/27/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[Etiology: unknown, possibly to dental work on Left upper molar. ]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826165
Page 37 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826166
Page 38 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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)[STD Exposure]
4.Start Date Time: Nov/6/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/6/2020 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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unprotected sex with a male]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826167
Page 39 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826168
Page 40 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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)[Left Otitis Externa]
4.Start Date Time: Nov/6/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Ear infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826169
Page 41 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826170
Page 42 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
 1.          Repeating Pages
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826171
Page 43 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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[ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826172
Page 44 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Iden
tifierCategory for Medica
tionConcomitant Medications Pre-sp
ecifiedName of Medicat
ionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826173
Page 45 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications Pre-specified:
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826174
Page 46 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionDose Descrip
tionForm Instance
 1.          Repeating
Pages
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826175
Page 47 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826176
Page 48 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826177
Page 49 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826178
Page 50 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.     Repeating Pages
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826179
Page 51 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826180
Page 52 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826181
Page 53 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826182
Page 54 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826183
Page 55 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826184
Page 56 of 178
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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?
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826185
Page 57 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826186
Page 58 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826187
Page 59 of 178
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/17/2020
2.Phase of Disposition: VACCINATION
3.Status: OTHER
4.Specify Status: [Cross over to V101]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826188
Page 60 of 178
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826189
Page 61 of 178
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826190
Page 62 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826191
Page 63 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826192
Page 64 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/17/2020
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826193
Page 65 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826194
Page 66 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Dec/17/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826195
Page 67 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
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 [BR8BZS]
5.bSample ID [BS724W]
5.cSample ID [BS724X]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826196
Page 68 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
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 [BR8BZR]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826197
Page 69 of 178
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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/17/2020 12:47
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
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826198
Page 70 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/16/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826199
Page 71 of 178
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826200
Page 72 of 178
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826201
Page 73 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/8/2021
2.Erroneous Visit
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826202
Page 74 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/8/2021
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 [BRJ3ZX]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826203
Page 75 of 178
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
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/8/2021 11:35
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
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826204
Page 76 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/5/2021
2.Erroneous Visit
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826205
Page 77 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/5/2021
3.Comments: [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826206
Page 78 of 178
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826207
Page 79 of 178
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826208
Page 80 of 178
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826209
Page 81 of 178
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826210
Page 82 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Feb/5/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826211
Page 83 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/17/2020
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826212
Page 84 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826213
Page 85 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jane Halpern  Approved Mar-10-2021 14:25:01 (UTC-07:00) Mountain Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JaneHalpern, 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.
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826214
Page 86 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-16-2020 15:41:41 (UTC-07:00) Mountain Time
(US & Canada)Dan VandeRiet Not Applicable
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826215
Page 87 of 178
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Dec-09-2020 11:01:47 (UTC-07:00) Mountain Time
(US & Canada)Subject was on vaccination temporary delay due to
SAE (illness). Subject was medically cleared to
received vaccination dose 2 on 07 Dec 2020.
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826216
Page 88 of 178
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-22-2021 18:27:31 (UTC-07:00) Mountain Time
(US & Canada)Crossed-over to V101.
Not Done
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826217
Page 89 of 178
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-22-2021 18:27:31 (UTC-07:00) Mountain Time
(US & Canada)Crossed-over to V101.
Not Done
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826218
Page 90 of 178
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-22-2021 18:27:31 (UTC-07:00) Mountain Time
(US & Canada)Crossed-over to V101.
Not Done
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826219
Page 91 of 178
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-22-2021 18:28:32 (UTC-07:00) Mountain Time
(US & Canada)Crossed-over to V101.
Not Done
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826220
Page 92 of 178
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-22-2021 18:28:32 (UTC-07:00) Mountain Time
(US & Canada)Crossed-over to V101.
Not Done
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826221
Page 93 of 178
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-22-2021 18:28:32 (UTC-07:00) Mountain Time
(US & Canada)Crossed-over to V101.
Not Done
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826222
Page 94 of 178
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-22-2021 18:28:32 (UTC-07:00) Mountain Time
(US & Canada)Crossed-over to V101.
Not Done
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826223
Page 95 of 178
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-22-2021 18:28:32 (UTC-07:00) Mountain Time
(US & Canada)Crossed-over to V101.
Not Done
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826224
Page 96 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormDec-17-2020 13:32:30 (UTC-07:00) Mountain Time
(US & Canada)Not Applicable
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826225
Page 97 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jane Halpern  Approved Mar-10-2021 14:25:01 (UTC-07:00) Mountain Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JaneHalpern, 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.
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826226
Page 98 of 178
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-16-2020 15:39:58
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-16-2020 15:39:58
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826227
Page 99 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-19-2020 00:07:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query.
Oct-16-2020 16:50:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dan VandeRiet Query 1: Answered Dates are correct.
Consent/screening took
place on 15 Oct; dosing
on 16 Oct.
Oct-16-2020 15:41:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date Informed Consent
Obtained is not the
same as the Date of
Visit. Please correct as
necessary.
Oct-16-2020 15:40:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/15/2020Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826228
Page 100 of 178
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-16-2020 15:39:33
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12211007Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Dec-10-2020 09:55:52
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1983Transcription Error
Oct-16-2020 15:39:26
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1983Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-16-2020 15:40:34
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-16-2020 15:40:34
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-16-2020 15:40:34
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
AMERICAN INDIAN OR ALASKA
NATIVEInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0826229
Page 101 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020 15:41:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
Oct/16/2020Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826230
Page 102 of 178
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-16-2020 15:42:13
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020 15:42:13
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020 15:42:13
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
COMPLETEDInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826231
Page 103 of 178
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Oct-16-2020 15:54:47
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Seasonal allergie
s
Start Date: UNK/UNK/201
2
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-16-2020 15:54:47
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 15:54:47
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
Seasonal allergiesInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-16-2020 15:54:47
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
UNK/UNK/2012Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-16-2020 15:54:47
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-16-2020 16:13:30
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Term: UveitisInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826232
Page 104 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Start Date: Jan/UNK/2006
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Oct-16-2020 16:13:30
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 16:13:30
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
UveitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-16-2020 16:13:30
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
Jan/UNK/2006Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-16-2020 16:13:30
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-16-2020 16:16:45
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Chronic intermittent b
ack pain
Start Date: UNK/UNK/2012
Ongoing: YESInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826233
Page 105 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.c Line/MH Number:
Date Location User Value Reason
Oct-16-2020 16:16:45
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 16:16:45
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
Chronic intermittent back painInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-16-2020 16:16:45
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
UNK/UNK/2012Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-16-2020 16:16:45
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-18-2020 15:21:35
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 4
Medical History Ter
m:Foot fracture
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
Jun/UNK/201
4Changed Information
Oct-16-2020 16:17:20
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4
Medical Histo
ry Term:Scar tissue in foot from
broken bones
Start Date: UNK/UNK/2014Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826234
Page 106 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Ongoing: NO
End Date:
Jun/UNK/2014
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826235
Page 107 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.d Line/MH Number:
Date Location User Value Reason
Oct-16-2020 16:17:20
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-18-2020
15:59:05
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Oct-18-2020
15:21:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Oct-18-2020
15:21:35
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Foot fractureChanged
Information
Oct-17-2020
08:23:15
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opened Multiple concepts
in the term SCAR
TISSUE IN
FOOT FROM
BROKEN
BONES. Please
split the term into
SCAR TISSUE
IN FOOT and
FOOT BROKEN
BONES and
submit separately.
Thank you.
Oct-16-2020
16:17:20
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
Scar tissue in foot fro
m broken bonesInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-16-2020 16:17:20 ACV0PFEINFP6000  Dan VandeRiet Data Entry: Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826236
Page 108 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-07:00) Mountain Time
(US & Canada)UNK/UNK/2014
1.d Ongoing:
Date Location User Value Reason
Oct-16-2020 16:17:20
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
NO
End Date:
Jun/UNK/2014Initial Entry
1.e
Date Location User Value Reason
Oct-18-2020 14:51:34
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 5
Medical History Ter
m:Syphilis
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/20
13Changed Information
Oct-16-2020 16:30:29
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:Syphillis
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/20
13Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826237
Page 109 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.e Line/MH Number:
Date Location User Value Reason
Oct-16-2020 16:30:29
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-18-2020
15:59:21
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Oct-18-2020
14:51:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Oct-18-2020
14:51:34
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SyphilisChanged
Information
Oct-16-2020
19:58:22
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opened Clarify
SYPHILLIS as
follows...Should
spelling be
SYPHILIS? If so
edit as such,
otherwise clarify.
Thank you.
Oct-16-2020
16:30:29
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
SyphillisInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-16-2020 16:30:29
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
UNK/UNK/2013Initial Entry
1.e Ongoing:
Date Location User Value Reason
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826238
Page 110 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-16-2020 16:30:29
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.f
Date Location User Value Reason
Oct-18-2020 14:51:51
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 6
Medical History Term
:Syphilis
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
Mar/10/202
0Changed Information
Oct-16-2020 16:31:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Term
:Syphillis
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
Mar/10/202
0Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826239
Page 111 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.f Line/MH Number:
Date Location User Value Reason
Oct-16-2020 16:31:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-18-2020
15:59:37
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Closed Discrepancy has
been closed.
Oct-18-2020
14:51:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Oct-18-2020
14:51:51
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SyphilisChanged
Information
Oct-16-2020
19:58:38
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Opened Clarify
SYPHILLIS as
follows...Should
spelling be
SYPHILIS? If so
edit as such,
otherwise clarify.
Thank you.
Oct-16-2020
16:31:03
(UTC-07:00)
Mountain Time (US
& Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
SyphillisInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-16-2020 16:31:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
Mar/UNK/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826240
Page 112 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-16-2020 16:31:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
NO
End Date:
Mar/10/2020Initial Entry
1.g
Date Location User Value Reason
Oct-16-2020 16:33:42
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:Anxiety
Start Date: Jun/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/20
18Initial Entry
1.g Line/MH Number:
Date Location User Value Reason
Oct-16-2020 16:33:42
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 16:33:42
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
AnxietyInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-16-2020 16:33:42
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
Jun/UNK/2016Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-16-2020 16:33:42
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826241
Page 113 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.h
Date Location User Value Reason
Oct-18-2020 15:23:50
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Histo
ry Term:Surgical revision of scar
tissue in foot
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
Jun/UNK/2014Initial Entry
1.h Line/MH Number:
Date Location User Value Reason
Oct-18-2020 15:23:50
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-18-2020 15:23:50
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Surgical revision of scar tissue in footInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-18-2020 15:23:50
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-18-2020 15:23:50
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/UNK/2014Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826242
Page 114 of 178
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020 16:32:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
Oct/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-16-2020 16:32:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
118.4Initial Entry
3. Unit:
Date Location User Value Reason
Oct-16-2020 16:32:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-16-2020 16:32:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
180.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-16-2020 16:32:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-16-2020 16:32:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
36.5Initial Entry
7.a
Date Location User Value Reason
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826243
Page 115 of 178
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-16-2020 16:32:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
Record Identifier:: 1
Temperature: 99.0
Temperature Unit: F
Temperature Location:
:FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-16-2020 16:32:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-16-2020 16:32:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
99.0Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-16-2020 16:32:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-16-2020 16:32:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
FOREHEADInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826244
Page 116 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-18-2020 15:02:38
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-18-2020 15:02:38
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Transcription Error
Oct-18-2020 14:59:22
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Randomization Date
10/Oct/2020 is before or
more than 1 day after
corresponding Date of
Visit 16/Oct/2020.
Please review and
update as appropriate.
Oct-18-2020 14:59:22
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-18-2020 14:59:22
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
109338Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826245
Page 117 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-18-2020 15:00:08
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-18-2020 15:00:08
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-18-2020 15:01:18
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-18-2020 15:00:08
(UTC-07:00) Mountain 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-18-2020 15:00:08
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-18-2020 15:01:18
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8BPDInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-18-2020 15:01:18
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR8BPDInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826246
Page 118 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b
Date Location User Value Reason
Oct-18-2020 15:01:44
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS71YWInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-18-2020 15:01:44
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BS71YWInitial Entry
5.c
Date Location User Value Reason
Oct-18-2020 15:02:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS71YXInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-18-2020 15:02:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BS71YXInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826247
Page 119 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-18-2020 15:02:55
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-18-2020 15:02:55
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-18-2020 15:03:31
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-18-2020 15:02:55
(UTC-07:00) Mountain 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-18-2020 15:02:55
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-18-2020 15:03:31
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8BPCInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-18-2020 15:03:31
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR8BPCInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826248
Page 120 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-18-2020 15:04:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-18-2020 15:04:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-18-2020 15:04:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-18-2020 15:04:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020 15:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-18-2020 15:04:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-18-2020 15:04:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826249
Page 121 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Oct-18-2020 15:04:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-18-2020 15:04:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-18-2020 15:04:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826250
Page 122 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-18-2020 15:04:30
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY N
OT COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826251
Page 123 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-11-2020
00:46:50
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 2: Close
dClosed per SITE
response - added to
PD tracker for
Clinical review
Dec-09-2020
11:02:42
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answ
eredSubject was on
vaccination
temporary delay due
to SAE (illness).
Subject was
medically cleared to
received vaccination
dose 2 on 07 Dec
2020.
Dec-08-2020
23:11:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opene
dPDQ RQ1: As per
your response, V2
was delayed for acute
illness. Thus, please
confirm whether
corresponding temp.
delay details can be
updated on
Vaccination form as
appropriate. Else
clarify.
Dec-08-2020
22:50:23
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 1: Close
dClosed per SITE
response, added to
PD tracker for
Clinical Review
Dec-08-2020
07:57:19
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Query 1: Answ
eredV2 was delayed for
acute illness. (See
SAE report). He was
hospitalized with
meningitis.
Dec-07-2020
23:56:32
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Opene
dPDQ: Date of visit at
V2_VAX2_L is out of
window for 29 days
from
V1_DAY1_VAX1_L
Dose Date. Please
verify and update.
Else, confirm in
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826252
Page 124 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
query response
appropriately. 
Dec-07-2020
15:01:54
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/7/2020New Information
Nov-11-2020
08:56:53
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
Nov/4/2020Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) 
(4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826253
Page 125 of 178
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Dec-07-2020 15:17:33
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/7/2020Initial Entry
2.a
Date Location User Value Reason
Dec-07-2020 15:17:33
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Location:: FOREHEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-07-2020 15:17:33
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-07-2020 15:17:33
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-07-2020 15:17:33
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Dec-07-2020 15:17:33
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (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-2021-5683-0826254
Page 126 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-07-2020 15:17:49
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-07-2020 15:17:49
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-07-2020 15:18:23
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-07-2020 15:17:49
(UTC-07:00) Mountain 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-07-2020 15:17:49
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/7/2020Initial Entry
5.a
Date Location User Value Reason
Dec-07-2020 15:18:23
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8BXJInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-07-2020 15:18:23
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR8BXJInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826255
Page 127 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-07-2020 14:29:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NONew Information
Nov-11-2020 08:56:09
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
YES
Date of First Delay:
Nov/4/2020
Reason(s) for Temporary Delay of Vac
cination
FEVER OR ACUTE ILLNESSInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-07-2020 14:30:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-07-2020 14:30:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-07-2020 15:01:54
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-07-2020 14:30:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Dose Date is not equal
to Date of Visit
04/Nov/2020 of the
corresponding Visit.
Please review and
update as appropriate.
Dec-07-2020 14:30:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/7/2020 13:00Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)
(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826256
Page 128 of 178
***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, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5. Anatomical Location:
Date Location User Value Reason
Dec-07-2020 14:30:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-07-2020 14:30:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-07-2020 14:30:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-07-2020 14:30:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSERV
ATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Dec-07-2020 14:30:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826257
Page 129 of 178
***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, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-29-2021 11:03:37
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Jan-29-2021 10:54:52
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Jan-29-2021 04:57:58
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY: It
appears V3 did not take
place because V101
occurred within 28d of
Vax2. If so, please
complete first EOT
page as status OTHER
with specify status field
explaining: subject
proceeded to open label
prior to V3 in the
blinded Rx phase
Jan-22-2021 18:27:31
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Jan-22-2021 18:27:31
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826258
Page 130 of 178
***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, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-22-2021 18:28:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-22-2021 18:28:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021 18:28:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-22-2021 18:28:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826259
Page 131 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000 Jane Halpern Form Created
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826260
Page 132 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-04-2020 17:32:02
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000 Jane Halpern Form Created
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826261
Page 133 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Nov-12-2020 12:19:41
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000 Dan VandeRiet Form Deleted New Information
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000 Jane Halpern Form Created
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826262
Page 134 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000 Jane Halpern Form Created
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826263
Page 135 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000 Jane Halpern Form Created
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826264
Page 136 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-17-2020 11:23:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Closed Response satisfies query
Nov-17-2020 08:35:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jane Halpern Query 2: Answered Date of diagnosis was 6
Nov. not 7 Nov.
Updated AE log.
Nov-15-2020 10:00:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Opened Per case narrative, other
additional event were
reported, Use of
antibiotics for "left otitis
externa and associated
facial cellulitis from
07Nov2020" Please
revise and update AE
log accordingly.
Nov-12-2020 12:27:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
Abscess in left jawInformation from
patient, waiting for
official medical records
Nov-06-2020 14:56:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-06-2020 12:41:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jane Halpern Query 1: Answered Dx by ED doctor
was"inflammation",
based on CT scan
showing temporalis
muscle asymetry and
?inflammation vs
infection. Headache is
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826265
Page 137 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
over the area of temple
that was tender and
slightly swollen. Will
f/u when he returns.
could be dental or TMJ
Nov-06-2020 09:58:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened clinical: Has a more
specific dx been made?
What are the results of
any evaluation/testing?
Is this soft tissue
swelling? Does the pt
have a hx of prior
episodes or prior hx
temporal headache?
Nov-04-2020 17:28:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
Left temporal/facial swellingInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
Oct/31/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-18-2020 07:18:23
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Closed Response satisfies
query
Dec-14-2020 19:05:46
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Dec-14-2020 19:05:46
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/2/2020 UNK:UNKNew Information
Dec-11-2020 08:37:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Opened Clin: please confirm if
this AE is still ongoing
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
YESInitial Entry
6. Toxicity Grade:
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826266
Page 138 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-12-2020 12:28:30
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
3New Information
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOT RELATED
If Not Related to study treatment(s), thi
s event is due to:
OTHER
If Other, specify:
Inflammation vs. infectionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826267
Page 139 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-14-2020 19:06:23
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-14-2020 19:06:23
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Dec-14-2020 19:05:46
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Abscess in left
jaw: Response to "What
was the outcome of this
adverse event?" is
'Recovering/Resolving'
but AE End Date/Time is
present.
Nov-19-2020 12:35:36
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
RECOVERING/RESOLVINGNew Information
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOT RECOVERED/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-04-2020 17:28:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826268
Page 140 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-04-2020 17:32:02
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-04-2020 17:32:02
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-17-2020 11:21:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Closed Response satisfies query
Nov-17-2020 08:35:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jane Halpern Query 2: Answered Changed data per query
Nov-15-2020 10:11:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Opened Per case narrative, ""subject
was treated for potential
sexually transmitted
diseases (STDs)". As this is
potential additional event,
please revise and update AE
log accordingly. Thank you.
Nov-14-2020 08:15:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-13-2020 17:57:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Meningitis BacterialTranscription Error
Nov-13-2020 14:09:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Nov-13-2020 14:09:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Bacterial MeningitisChanged Information
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826269
Page 141 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-13-2020 05:25:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020449668,
the term in AE CRF was
reported as Meningitis'
while recorded as Bacterial
meningitis in Safety
database . Please confirm
correct term. If safety
update is required, please
submit a follow-up form.
Nov-12-2020 12:22:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
MeningitisSpoke with subject who
said that he had been
admitted to a hospital with
meningitis
Nov-04-2020 17:32:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
Headache, Left temporal areaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-12-2020 12:23:14
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
Nov/10/2020 UNK:UNKNew Information
Nov-04-2020 17:32:02
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
Oct/29/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-16-2020 14:02:29
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NO
End Date Time:
Dec/2/2020 UNK:UNKNew Information
Nov-04-2020 17:32:02
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-12-2020 12:23:31
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
3New Information
Nov-04-2020 17:32:02
(UTC-07:00) Mountain TimeACV0PFEINFP6000  Jane Halpern Data Entry:
1Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826270
Page 142 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(US & Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-13-2020 05:24:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020 12:24:11
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Meningitis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-12-2020 12:24:11
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
YES
Is this serious event associated with c
ongenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prol
ong hospitalization?
YES
Did this serious event result in persist
ent or significant disability/incapacity
?
NO
Is this serious event life threatening?
YES
Other medically important serious ev
ent
NONew Information
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826271
Page 143 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Nov-04-2020 17:32:02
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-04-2020 17:32:02
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-12-2020 12:25:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Dan VandeRiet Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
Bacterial infectionSubject states he was
admitted with
"bacterial meningitis".
We do not yet have
medical records to
confirm this.
Nov-04-2020 17:32:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
L temporal/Facial inflammationInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-04-2020 17:32:02
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-04-2020 17:32:02
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
YESInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826272
Page 144 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-04-2020 17:32:02
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Dec-17-2020
03:11:39
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies query
Dec-16-2020
22:00:18
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
3: Clo
sedResponse satisfies query
Dec-16-2020
14:03:21
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Jane Halpern Query
3: Ans
weredChanged data per query
Dec-15-2020
02:01:54
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
3: Op
enedDMW6461436;Response to "What
was the outcome of this adverse
event?" is 'Recovered/Resolved' or
'Recovered/Resolved with Sequelae'
but End Date/Time is missing.
Please review and update as
appropriate.
Dec-14-2020
19:07:04
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Ans
weredNew Information
Dec-14-2020
19:07:04
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Data
Entry
:
RECO
VERE
D/RE
SOLVNew Information
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826273
Page 145 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
ED
Dec-11-2020
04:08:45
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
2: Op
enedSAE
RECON:AER#2020449668 ,outcome
was updated to Recovered/Resolved
on Safety database while retained as
RECOVERING/RESOLVING in
AE CRF.Please confirm correct
outcome.If safety update is
required,please submit a follow-up
form
Nov-20-2020
01:36:42
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-19-2020
12:13:27
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredNew Information
Nov-19-2020
12:13:27
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Jane Halpern Data
Entry
:
RECO
VERI
NG/R
ESOL
VINGNew Information
Nov-19-2020
04:29:36
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
1: Op
enedSAE
RECON:AER#2020449668 ,outcome
was updated to
RECOVERING/RESOLVING on
Safety database while reported as
Not Recovered/Not Resolved in AE
CRF.Please confirm correct
outcome.If safety update is
required,please submit a follow-up
form
Nov-04-2020
17:32:02
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Jane Halpern Data
Entry
:
NOT
RECO
VERE
D/NO
T RE
SOLVInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826274
Page 146 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
ED
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-04-2020 17:32:02
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-13-2020 05:24:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020449668Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826275
Page 147 of 178
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
Pain radiating from left temple/jaw to ne
ck and shoulderInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
Oct/27/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
2Initial Entry
7. Is the adverse event serious?
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826276
Page 148 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOT RELATED
If Not Related to study treatment(s), thi
s event is due to:
OTHER
If Other, specify:
Etiology: unknown, possibly to de
ntal work on Left upper molar.Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
YESInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826277
Page 149 of 178
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
*** THIS REPEATING FORM HAS BEEN DELETED ***
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOT RECOVERED/NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-11-2020 10:28:03
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826278
Page 150 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-17-2020
13:40:14
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Clos
edDiscrepancy has been closed.
Nov-17-2020
11:43:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredThe prophylaxis is not an AE.
It is the treatment he received
for the exposure.
Nov-17-2020
11:43:48
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
STD ExposureThe prophylaxis is not an AE.
It is the treatment he received
for the exposure.
Nov-17-2020
10:33:16
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Open
edMultiple concepts in the term
STD
EXPOSURE/PROPHYLAXIS.
Split the term into STD
EXPOSURE and STD
PROPHYLAXIS and report as
separate entries. Thank you.
Nov-17-2020
08:19:40
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
STD Exposure
/prophylaxisInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826279
Page 151 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
4. Start Date Time:
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
Nov/6/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-17-2020 09:54:57
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NO
End Date Time:
Nov/6/2020 UNK:UNKNew Information
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826280
Page 152 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOT RELATED
If Not Related to study treatment(s), thi
s event is due to:
OTHER
If Other, specify:
Unprotected sex with a maleInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-17-2020 08:19:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826281
Page 153 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-19-2020
05:38:53
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 1: Clos
edResponse satisfies
query
Nov-17-2020
11:45:02
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query (autoquery) Query 1: Ans
weredRemoved cellulitis. It
was a result of the left
jaw abcess.
Nov-17-2020
11:45:02
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
Left Otitis Ext
ernaRemoved cellulitis. It
was a result of the left
jaw abcess.
Nov-17-2020
10:35:22
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Ope
nedPlease split the term
LEFT OTITIS
EXTERNA WITH
CELLULITIS into
LEFT OTITIS
EXTERNA and the
term
CELLULITIS.Thank
you.
Nov-17-2020
08:33:39
(UTC-07:00)
Mountain TimeACV0PFEINFP6000  Jane Halpern Data Entry:
Left Otitis Ext
erna with cell
ulitisInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826282
Page 154 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(US & Canada)
4. Start Date Time:
Date Location User Value Reason
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
Nov/6/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-18-2020 07:17:40
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Closed Response satisfies
query
Dec-14-2020 19:07:50
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Dec-14-2020 19:07:50
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/18/2020 UNK:UNKNew Information
Dec-11-2020 09:07:30
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Opened Clin: Please confirm if
AE is still ongoing
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-17-2020 08:33:39
(UTC-07:00) Mountain TimeACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826283
Page 155 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(US & Canada)
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOT RELATED
If Not Related to study treatment(s), thi
s event is due to:
OTHER
If Other, specify:
Ear infectionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-14-2020 19:08:10 ACV0PFEINFP6000  auto query Query 1: Closed Close Auto Query
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826284
Page 156 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
(UTC-07:00) Mountain Time
(US & Canada)(autoquery)
Dec-14-2020 19:08:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Dec-14-2020 19:07:50
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Left Otitis
Externa: Response to
"What was the outcome
of this adverse event?" is
'Recovering/Resolving'
but AE End Date/Time is
present.
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-17-2020 08:33:39
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Jane Halpern Data Entry:
NOInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826285
Page 157 of 178
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-29-2021 10:56:07
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Changed Information
Jan-29-2021 10:54:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/7/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-29-2021 10:54:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Jan-29-2021 10:54:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
4. Specify Status:
Date Location User Value Reason
Jan-29-2021 10:54:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Cross over to V101Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826286
Page 158 of 178
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020 13:31:47
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826287
Page 159 of 178
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-18-2020 11:36:52
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-18-2020 03:12:50
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened The response indicates
participant was
unblinded, however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Dec-17-2020 13:31:57
(UTC-07:00) Mountain 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-17-2020 13:31:57
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for Vaccin
ation 3
Participant is:
eligible per local/national recommen
dations and confirmed to have receiv
ed only placebo at Vaccination 1/2Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826288
Page 160 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020 13:32:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826289
Page 161 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-17-2020 13:32:21
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/17/2020Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826290
Page 162 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-17-2020 13:32:52
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-17-2020 13:32:52
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-17-2020 13:32:52
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826291
Page 163 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020 14:03:44
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020 14:03:44
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 14:03:57
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-17-2020 14:03:44
(UTC-07:00) Mountain 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-17-2020 14:03:44
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/17/2020Initial Entry
5.a
Date Location User Value Reason
Dec-17-2020 14:03:57
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8BZSInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 14:03:57
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR8BZSInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826292
Page 164 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.b
Date Location User Value Reason
Dec-17-2020 14:04:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS724WInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-17-2020 14:04:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BS724WInitial Entry
5.c
Date Location User Value Reason
Dec-17-2020 14:04:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS724XInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-17-2020 14:04:32
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BS724XInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826293
Page 165 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020 13:33:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020 13:33:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 13:33:24
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-17-2020 13:33:12
(UTC-07:00) Mountain 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-17-2020 13:33:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/17/2020Initial Entry
5.a
Date Location User Value Reason
Dec-17-2020 13:33:24
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8BZRInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 13:33:24
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR8BZRInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826294
Page 166 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-17-2020 14:05:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-17-2020 14:05:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-17-2020 14:05:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-17-2020 14:05:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020 12:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-17-2020 14:05:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Dec-17-2020 14:05:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826295
Page 167 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-17-2020 14:05:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-17-2020 14:05:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-17-2020 14:05:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-17-2020 14:05:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Dec-17-2020 14:05:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826296
Page 168 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-18-2020 11:36:52
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Gwen
LivingstonData Entry:
Dec/16/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-18-2020 11:36:52
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Gwen
LivingstonData Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826297
Page 169 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-08-2021 12:01:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826298
Page 170 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-08-2021 12:02:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-08-2021 12:02:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-08-2021 12:02:23
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-08-2021 12:02:10
(UTC-07:00) Mountain 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-08-2021 12:02:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/8/2021Initial Entry
5.a
Date Location User Value Reason
Jan-08-2021 12:02:23
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRJ3ZXInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-08-2021 12:02:23
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BRJ3ZXInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826299
Page 171 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-08-2021 12:03:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-08-2021 12:03:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-08-2021 12:03:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-08-2021 12:03:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021 11:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-08-2021 12:03:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-08-2021 12:03:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826300
Page 172 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-08-2021 12:03:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-08-2021 12:03:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-08-2021 12:03:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-08-2021 12:03:10
(UTC-07:00) Mountain 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-08-2021 12:03:10
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826301
Page 173 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-05-2021 15:52:48
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Gwen
LivingstonData Entry:
Feb/5/2021Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826302
Page 174 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-05-2021 15:53:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-05-2021 15:53:00
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Gwen
LivingstonData Entry:
YES
Date of Contact:
Feb/5/2021Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826303
Page 175 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-09-2021 09:11:18
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/5/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-09-2021 09:11:18
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Feb-09-2021
22:24:33
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-09-2021
16:32:31
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answe
redOriginal value is
correct
Feb-09-2021
16:30:15
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-09-2021
16:29:55
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opene
dResponse to "Status"
is COMPLETED but
"Specify Status" is
Provided.
Feb-09-2021
14:07:04
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: Opene
dDMW7210764;Status
on the Disposition -
Treatment form is
COMPLETED, but
Visit 3 Date is
missing. Please review
and update as
appropriate.
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0826304
Page 176 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Feb-09-2021
09:11:18
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Feb-09-2021 16:30:15
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Changed Information
Feb-09-2021 16:29:55
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Visit 3 not done due to crossover to V101
.Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826305
Page 177 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-29-2021 10:54:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-18-2020 15:02:38
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDTranscription Error
Oct-18-2020 14:59:22
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-16-2020 15:42:13
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-29-2021 10:56:07
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/17/2020Changed Information
Jan-29-2021 10:54:12
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Jan/7/2021Initial Entry
Oct-18-2020 15:02:38
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/16/2020Transcription Error
Oct-18-2020 14:59:22
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/10/2020Initial Entry
Oct-16-2020 15:42:13
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/16/2020Initial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0826306
Page 178 of 178
***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: 1221 Site Name: (1221) Center for American Indian Health - Gallup
Subject No: 12211007 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Mar-10-2021 13:55:42
(UTC-07:00) Mountain Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae4041\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0826307