125742 S1 M5 CRF c4591001 1220 12201052

Document text

Page 1 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825363
Page 2 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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
Nov/18/2020
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825364
Page 3 of 149
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12201052]
2.Birth Date: 1985
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825365
Page 4 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/18/2020
2.Erroneous Visit
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825366
Page 5 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825367
Page 6 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathNov/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825368
Page 7 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[acne]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/2002
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825369
Page 8 of 149
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825370
Page 9 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/18/2020
2.Weight: [190.2]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [28.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825371
Page 10 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Nov/18/2020
2.Randomization Number: [116356]
3.Randomization Group: [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825372
Page 11 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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:
Nov/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8P6H]
5.bSample ID [BS70J3]
5.cSample ID [BS70JL]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825373
Page 12 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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:
Nov/18/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8P9X]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825374
Page 13 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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: Nov/18/2020 16:28
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
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825375
Page 14 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825376
Page 15 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/8/2020
2.Erroneous Visit
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825377
Page 16 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Dec/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825378
Page 17 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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/8/2020
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 [BR8PDT]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825379
Page 18 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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/8/2020 15:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825380
Page 19 of 149
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825381
Page 20 of 149
***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, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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:
Jan/11/2021
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 [BR8P7Y] Comments
5.bSample ID [BS70XW] Comments
5.cSample ID [BS70ZM] Comments
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825382
Page 21 of 149
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825383
Page 22 of 149
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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 [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825384
Page 23 of 149
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825385
Page 24 of 149
***Confidential***
 
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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 [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825386
Page 25 of 149
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825387
Page 26 of 149
***Confidential***
 
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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 [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825388
Page 27 of 149
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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:
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825389
Page 28 of 149
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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: [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825390
Page 29 of 149
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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 [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825391
Page 30 of 149
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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 [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825392
Page 31 of 149
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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?
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825393
Page 32 of 149
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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:
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825394
Page 33 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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:
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825395
Page 34 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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 [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825396
Page 35 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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:
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825397
Page 36 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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 [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825398
Page 37 of 149
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Soreness at injection sit
e Nov/19/2020 0
8:00 NO
End Date Time:
Nov/19/2020 22:00
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Chills  Dec/8/2020 18:
05 NO
End Date Time:
Dec/9/2020 08:00
 Repeating
Pages
 3.ADVERSE EV
ENT 3  Soreness at injection sit
e Dec/8/2020 18:
05 NO
End Date Time:
Dec/9/2020 08:00
 Repeating
Pages
 4.ADVERSE EV
ENT 4  headache  Dec/9/2020 07:
00 NO
End Date Time:
Dec/10/2020 07:00
 Repeating
Pages
 5.ADVERSE EV
ENT 5  Malaise  Dec/9/2020 07:
00 NO
End Date Time:
Dec/10/2020 07:00
 Repeating
Pages
 6.ADVERSE EV
ENT 6  Lymphadenopathy Left
axillary Dec/9/2020 06:
00 NO
End Date Time:
Dec/14/2020 07:00
 Repeating
Pages
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825399
Page 38 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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)[Soreness at injection site]
4.Start Date Time: Nov/19/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/19/2020 22:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825400
Page 39 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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[ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825401
Page 40 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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)[Chills]
4.Start Date Time: Dec/8/2020 18:05
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/9/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825402
Page 41 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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[ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825403
Page 42 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Soreness at injection site]
4.Start Date Time: Dec/8/2020 18:05
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/9/2020 08:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825404
Page 43 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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[ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825405
Page 44 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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)[headache]
4.Start Date Time: Dec/9/2020 07:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/10/2020 07:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825406
Page 45 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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[ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825407
Page 46 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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)[Malaise]
4.Start Date Time: Dec/9/2020 07:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/10/2020 07:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825408
Page 47 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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[ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825409
Page 48 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Lymphadenopathy Left axillary]
4.Start Date Time: Dec/9/2020 06:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/14/2020 07:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825410
Page 49 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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[ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825411
Page 50 of 149
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825412
Page 51 of 149
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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[ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825413
Page 52 of 149
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825414
Page 53 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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: //
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825415
Page 54 of 149
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825416
Page 55 of 149
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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?
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825417
Page 56 of 149
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825418
Page 57 of 149
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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?
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825419
Page 58 of 149
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825420
Page 59 of 149
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825421
Page 60 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825422
Page 61 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825423
Page 62 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825424
Page 63 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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:
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825425
Page 64 of 149
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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?
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825426
Page 65 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825427
Page 66 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825428
Page 67 of 149
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825429
Page 68 of 149
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825430
Page 69 of 149
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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 [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825431
Page 70 of 149
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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 [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825432
Page 71 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Jan/11/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825433
Page 72 of 149
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/23/2020
2.Erroneous Visit
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825434
Page 73 of 149
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825435
Page 74 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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: [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825436
Page 75 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/23/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825437
Page 76 of 149
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825438
Page 77 of 149
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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: [ ]
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825439
Page 78 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Jan/11/2021
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825440
Page 79 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825441
Page 80 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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
 Approved Mar-11-2021 11:35:45 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825442
Page 81 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormNov-18-2020 15:48:18 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825443
Page 82 of 149
***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, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-12-2021 08:26:43 (UTC-07:00) Mountain
Time (US & Canada)Serum-Send
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825444
Page 83 of 149
***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, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-12-2021 08:27:15 (UTC-07:00) Mountain
Time (US & Canada)Serum-Retain
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825445
Page 84 of 149
***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, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-12-2021 08:30:15 (UTC-07:00) Mountain
Time (US & Canada)Serum-Retain
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825446
Page 85 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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
 Approved Mar-11-2021 11:35:45 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-19-2021 13:25:38 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit  Approved Jan-23-2021 08:07:12 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-11-2021 10:32:43 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit  Approved Jan-11-2021 09:57:26 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825447
Page 86 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Affidavit:
By my dated signature below, I, LauraHammit, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-08-2020 15:24:34 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit  Approved Dec-04-2020 23:00:38 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LauraHammit, 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.
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825448
Page 87 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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
Nov-18-2020 15:46:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Nov-18-2020 15:46:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825449
Page 88 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-18-2020 15:46:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Nov/18/2020Initial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825450
Page 89 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-18-2020 15:45:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12201052Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Nov-18-2020 15:45:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1985Enrollment Entry
3. Sex:
Date Location User Value Reason
Nov-18-2020 15:46:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-18-2020 15:46:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-18-2020 15:46:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825451
Page 90 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-18-2020 15:47:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/18/2020Initial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825452
Page 91 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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
Nov-18-2020 15:48:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-18-2020 15:48:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-18-2020 15:48:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825453
Page 92 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Nov-18-2020 16:01:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:seasonal aller
gies
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-18-2020 16:01:30
(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
Nov-18-2020 16:01:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergiesInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-18-2020 16:01:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-18-2020 16:01:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825454
Page 93 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-18-2020 16:02:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:acne
Start Date: UNK/UNK/199
9
Ongoing: NO
End Date:
UNK/UNK/
2002Initial Entry
1.b Line/MH Number:
Date Location User Value Reason
Nov-18-2020 16:02:12
(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
Nov-18-2020 16:02:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
acneInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-18-2020 16:02:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1999Initial Entry
1.b Ongoing:
Date Location User Value Reason
Nov-18-2020 16:02:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2002Initial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825455
Page 94 of 149
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-18-2020 15:48:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825456
Page 95 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Nov-18-2020 15:49:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-18-2020 15:49:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
190.2Initial Entry
3. Unit:
Date Location User Value Reason
Nov-18-2020 15:49:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Nov-18-2020 15:49:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Nov-18-2020 15:49:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-18-2020 15:49:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.1Initial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825457
Page 96 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.a
Date Location User Value Reason
Nov-18-2020 15:49:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Nov-18-2020 15:49:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-18-2020 15:49:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.5Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-18-2020 15:49:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Nov-18-2020 15:49:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825458
Page 97 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-18-2020 16:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-18-2020 16:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
116356Initial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825459
Page 98 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-18-2020 15:49:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-18-2020 15:49:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-19-2020 09:38:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-19-2020 02:37:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-18-2020 15:49:52
(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.
Nov-18-2020 15:49:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/18/2020Initial Entry
5.a
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0825460
Page 99 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-19-2020 09:38:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8P6HInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-19-2020 09:38:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8P6HInitial Entry
5.b
Date Location User Value Reason
Nov-19-2020 09:39:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS70J3Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-19-2020 09:39:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS70J3Initial Entry
5.c
Date Location User Value Reason
Nov-19-2020 09:40:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS70JLInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-19-2020 09:40:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS70JLInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (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-2021-5683-0825461
Page 100 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-18-2020 15:50:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-18-2020 15:50:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-19-2020 09:37:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-19-2020 02:37:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-18-2020 15:50:04
(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.
Nov-18-2020 15:50:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/18/2020Initial Entry
5.a
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),(b)
(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825462
Page 101 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Nov-19-2020 09:37:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8P9XInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-19-2020 09:37:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8P9XInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825463
Page 102 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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
Nov-18-2020 16:39:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-18-2020 16:39:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-18-2020 16:39:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-18-2020 16:39:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/18/2020 16:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-18-2020 16:39:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-18-2020 16:39:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825464
Page 103 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Route:
Date Location User Value Reason
Nov-18-2020 16:39:55
(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
Nov-18-2020 16:39:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-18-2020 16:39:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825465
Page 104 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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
Nov-18-2020 15:50:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825466
Page 105 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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-08-2020 15:51:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020Initial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825467
Page 106 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Dec-08-2020 15:51:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020Initial Entry
2.a
Date Location User Value Reason
Dec-08-2020 15:51:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 97.7
Temperature Unit
:F
Temperature Loc
ation::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Dec-08-2020 15:51:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-08-2020 15:51:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-08-2020 15:51:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825468
Page 107 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
2.a Temperature Location:
Date Location User Value Reason
Dec-08-2020 15:51:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825469
Page 108 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-08-2020 15:51:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-08-2020 15:51:51
(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-08-2020 16:18:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-08-2020 15:51:51
(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-08-2020 15:51:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/8/2020Initial Entry
5.a
Date Location User Value Reason
Dec-08-2020 16:18:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8PDTInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825470
Page 109 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Dec-08-2020 16:18:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8PDTInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825471
Page 110 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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-08-2020 15:52:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-08-2020 15:52:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Dec-08-2020 15:52:08
(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-08-2020 15:52:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020 15:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-08-2020 15:52:08
(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-08-2020 15:52:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825472
Page 111 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Route:
Date Location User Value Reason
Dec-08-2020 15:52:08
(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-08-2020 15:52:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Dec-08-2020 15:52:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825473
Page 112 of 149
***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, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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-11-2021 10:32:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/11/2021Initial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825474
Page 113 of 149
***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, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-11-2021 10:33:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-11-2021 10:33:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-12-2021 08:26:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-11-2021 10:33:05
(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-11-2021 10:33:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Jan-12-2021 08:27:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825475
Page 114 of 149
***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, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a
Date Location User Value Reason
Jan-12-2021 08:26:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8P7YInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-12-2021 08:26:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8P7YInitial Entry
5.b
Date Location User Value Reason
Jan-12-2021 08:27:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS70XWInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-12-2021 08:27:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS70XWInitial Entry
5.c
Date Location User Value Reason
Jan-12-2021 08:30:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS70ZMInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-12-2021 08:30:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS70ZMInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (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-2021-5683-0825476
Page 115 of 149
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825477
Page 116 of 149
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825478
Page 117 of 149
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825479
Page 118 of 149
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825480
Page 119 of 149
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825481
Page 120 of 149
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825482
Page 121 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-08-2020 15:24:34
(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
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Soreness at injection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/19/2020 22:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825483
Page 122 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-08-2020 15:24:34
(UTC-07:00) MountainACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825484
Page 123 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-08-2020 15:24:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825485
Page 124 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-11-2020 16:04:55
(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
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ChillsInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020 18:05Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/9/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825486
Page 125 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-11-2020 16:04:55
(UTC-07:00) MountainACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825487
Page 126 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-11-2020 16:04:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825488
Page 127 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-11-2020 16:06:12
(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
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Soreness at injection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/8/2020 18:05Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/9/2020 08:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825489
Page 128 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-11-2020 16:06:12
(UTC-07:00) MountainACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825490
Page 129 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-11-2020 16:06:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825491
Page 130 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-11-2021 10:48:01
(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
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
headacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/9/2020 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-11-2021 10:49:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/10/2020 07:00Transcription Error
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:Initial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825492
Page 131 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Dec/9/2020 07:00
6. Toxicity Grade:
Date Location User Value Reason
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-11-2021 10:50:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825493
Page 132 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-11-2021 10:48:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825494
Page 133 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-11-2021 10:49:23
(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
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MalaiseInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/9/2020 07:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/10/2020 07:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825495
Page 134 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-11-2021 10:49:23
(UTC-07:00) MountainACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825496
Page 135 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-11-2021 10:49:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825497
Page 136 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Category:
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-11-2021 14:21:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Lymphadenopathy Left axillar
yTranscription Error
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LymphadenopathyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/9/2020 06:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/14/2020 07:00Initial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825498
Page 137 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
6. Toxicity Grade:
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825499
Page 138 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-11-2021 10:51:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825500
Page 139 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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-11-2021 10:34:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/11/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-11-2021 10:34:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Jan-11-2021 10:34:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825501
Page 140 of 149
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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-19-2021 13:25:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/23/2020Initial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825502
Page 141 of 149
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 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
Mar-09-2021 16:10:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Mar-09-2021 15:34:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Mar-09-2021 15:34:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only pla
cebo at Vaccination 1/2Transcription Error
Mar-09-2021 08:33:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please review if
correct selection has
been made here.
Treatment Unblind
performed ('Assess
for Additional
Vax'). Therefore,
was the subject
willing to
participate in revax
and eligible for
unblind? (NB
eligible is not
related to Rx arm)
Mar-08-2021 10:51:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Candidate CLINQUERY:
Please review if
correct selection has
been made here.
Treatment Unblind
performed ('Assess
for Additional
Vax'). Therefore,
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825503
Page 142 of 149
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
was the subject
willing to
participate in revax
and eligible for
unblind? (NB
eligible is not
related to Rx arm)
Feb-19-2021 13:25:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willing to
return for Vaccination 3 OR o
therwise not eligibleInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825504
Page 143 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-26-2021 12:55:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/23/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Mar-10-2021
10:39:14
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
3: Clo
sedResponse satisfies
query
Mar-09-2021
15:37:09
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
3: An
swere
dParticipant was
unblinded 23 DEC
2020. Pt. is willing to
return, eligible and
NOT confirmed to
have received placebo.
Information is
confirmed.
Mar-04-2021
23:16:02
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
3: Rei
ssued:
Opene
dDM: Please update
selection on this form
OR confirm 1) If the
Unblinding occurred
before the participant
was determined to be
willing/eligible for
Vaccination 3, or 2) If
the participant later
decided to continue in
the study and not
proceed with VAX3.
Mar-04-2021
16:04:46
(UTC-07:00)
Mountain
Time (US &ACV0PFEINFP6000  Query
3: An
swere
dAll participants were
contacted when eligible
locally to receive
vaccine and were asked
if they wanted
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)
(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825505
Page 144 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Canada) unblinded
Mar-04-2021
01:44:54
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
3: Rei
ssued:
Opene
dDM: Please update
selection on this form
OR confirm 1)
participant was
assigned to placebo and
returned to safety FUP
or 2) treatment
unblinded before
subject contacted to
confirm
willingness/eligibility
to proceed with Vax 3.
Thank you.
Mar-03-2021
16:28:55
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
4: Clo
sednew query issued
Mar-03-2021
08:37:22
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
3: An
swere
dParticipant is NOT
eligible or willing to
return for vaccine. Date
Entry Guidelines 8.66
FAQ#3
Mar-03-2021
08:36:56
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
4: An
swere
dParticipant is NOT
eligible or willing to
return for vaccine. Date
Entry Guidelines 8.66
FAQ#3
Mar-03-2021
02:42:45
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedClosed per data
updated by site.
Mar-03-2021
02:40:24
(UTC-07:00)
Mountain
Time (US &ACV0PFEINFP6000  Query
3: Rei
ssued:
Opene
dAs Subject is NOT
willing to return for
Vax 3, please confirm
if participant was
assigned to placebo and
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (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-2021-5683-0825506
Page 145 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Canada) returned to safety FUP
or treatment Unblinded
before subject
contacted to confirm
willingness/eligibility
to proceed with Vax 3,
Else, clarify.
Mar-02-2021
22:21:08
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
4: Op
enedDMW7580036;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Mar-02-2021
16:33:32
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
3: An
swere
dChanged Information
Mar-02-2021
16:33:32
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: An
swere
dChanged Information
Mar-02-2021
16:33:32
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL VChanged Information
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825507
Page 146 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
ACCI
NATI
ON
Mar-02-2021
07:06:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
3: Op
enedDM RQ1: As per
response provided-
Vaccine Recipient,
please verify eCCG
section 8.66 FAQ#3
and update the data in
database accordingly.
Else clarify.
Mar-02-2021
02:53:32
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
Mar-02-2021
00:08:50
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Query
2: Op
enedIVRS Reconciliation:
Other is selected as the
primary reason for
unblinding but
matching blind break is
not captured in IRT.
Please correct primary
reason in Inform or
confirm as correct”.
Mar-01-2021
12:46:50
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dChanged Information
Mar-01-2021
12:46:50
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Data
Entry
:
OTH
ER
If ot
her,
spec
ify:
Va
cciChanged Information
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825508
Page 147 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
ne
Re
cip
ien
t
Feb-26-2021
23:13:49
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7482250;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Feb-26-2021
12:55:29
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000  Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0825509
Page 148 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-11-2021 10:34:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Nov-18-2020 16:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Nov-18-2020 15:48:35
(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-11-2021 10:34:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Jan/11/2021Initial Entry
Nov-18-2020 16:36:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/18/2020Initial Entry
Nov-18-2020 15:48:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/18/2020Initial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0825510
Page 149 of 149
***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: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201052 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Dec-03-2020 15:47:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae30d0\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825511