125742 S1 M5 CRF c4591001 1220 12201020

Document text

Page 1 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824796
Page 2 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/16/2020
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824797
Page 3 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Demography
1.Subject ID [12201020]
2.Birth Date: 1994
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): AMERICAN INDIAN OR ALASKA NATIVE
6.Racial Designation:
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824798
Page 4 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824799
Page 5 of 392
***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: 12201020 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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824800
Page 6 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824801
Page 7 of 392
***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: 12201020 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:[Admission for labor and delivery]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[uncomplicated kidney stones]
Start Date: Aug/13/2020
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chlamydia infection]
Start Date: Mar/13/2020
Ongoing: NO
End Date:
Mar/17/2020
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chlamydia infection]
Start Date: Jun/17/2011
Ongoing: NO
End Date:
Jun/17/2011
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824802
Page 8 of 392
***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: 12201020 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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824803
Page 9 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
2.Weight: [199.6]
3.Unit: LB
4.Height: [62.5]
5.Unit: in
6.Body Mass Index: [35.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824804
Page 10 of 392
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/16/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824805
Page 11 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/16/2020
2.Randomization Number: [109218]
3.Randomization Group: [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824806
Page 12 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8P5G] Comments
5.bSample ID [BS70HJ] Comments
5.cSample ID [BS70HX] Comments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824807
Page 13 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8PHY]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824808
Page 14 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/16/2020 13:35
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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824809
Page 15 of 392
***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: 12201020 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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824810
Page 16 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/6/2020
2.Erroneous Visit
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824811
Page 17 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Vital Signs
1.Date: Nov/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824812
Page 18 of 392
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/6/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824813
Page 19 of 392
***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: 12201020 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/6/2020
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 [BR8PGP]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824814
Page 20 of 392
***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: 12201020 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/6/2020 12:12
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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824815
Page 21 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824816
Page 22 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/4/2020
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 [BS70W8] Comments
5.bSample ID [BS70K7] Comments
5.cSample ID [BR8P74] Comments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824817
Page 23 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824818
Page 24 of 392
***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: 12201020 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 [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824819
Page 25 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824820
Page 26 of 392
***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: 12201020 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 [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824821
Page 27 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824822
Page 28 of 392
***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: 12201020 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 [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824823
Page 29 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/7/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824824
Page 30 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/7/2021
2.Date of First Symptom Started: Jan/6/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/10/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824825
Page 31 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824826
Page 32 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descrip
tionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824827
Page 33 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824828
Page 34 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
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: 12201020 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_SELF
3.Sample Collected? YES
Date of Collection:
Jan/7/2021
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 [RW87443]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824829
Page 35 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: 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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? NO Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Participant collected self swab.] Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824830
Page 36 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824831
Page 37 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Treatment Identi
fierCon Non-Drug Treatments Pre-sp
ecifiedTreatment Treatment Start Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicab
le Not Applicab
le Not Applicab
le Repeating
Pages
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824832
Page 38 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Applicable
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824833
Page 39 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824834
Page 40 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category of Clinical Event
:Subcategory of Clinical Even
tDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Repeating Pages
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824835
Page 41 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: Not Applicable Comments
2.Subcategory of Clinical Event: Not Applicable Comments
3.Was a diagnosis obtained? Not Applicable Comments
4.Toxicity Grade: Not Applicable Comments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824836
Page 42 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.Not Applicable  Not Appli
cable Not Applic
able Not Applic
able Sponsor-Defined
IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824837
Page 43 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Lab Chemistry Details
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: C Reactive Protein_PX329
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824838
Page 44 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Alanine Aminotransferase_PX30
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Aspartate Aminotransferase_PX28
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824839
Page 45 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Alkaline Phosphatase_PX35
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Bilirubin_PX21
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824840
Page 46 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Blood Urea Nitrogen_PX47
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Creatinine_PX48
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824841
Page 47 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Category for
Lab TestVendor Name (
DERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.Not Applicabl
e Not Applicable  Not Appli
cable Not Appli
cable Sponsor-Define
d IdentifierTest: Result:
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable 
Not Applicable  Not Appli
cable Not Appli
cable Repeating
Pages
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824842
Page 48 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Laboratory Data Hematology
1.Lab Panel: Not Applicable Comments
2.Laboratory Name and Address Not Applicable
[ ]Comments
3.Collection Date: Not Applicable
//Comments
4.Specimen Type: Not Applicable Comments
Lab Result
5.aSponsor ID: Not Applicable
[ ]Comments
Test: Hemoglobin_PX1
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824843
Page 49 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.bSponsor ID: Not Applicable
[ ]Comments
Test: Hematocrit_PX2
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.cSponsor ID: Not Applicable
[ ]Comments
Test: Erythrocytes_PX3
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824844
Page 50 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.dSponsor ID: Not Applicable
[ ]Comments
Test: Platelets_PX5
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.eSponsor ID: Not Applicable
[ ]Comments
Test: Leukocytes_PX7
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824845
Page 51 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.fSponsor ID: Not Applicable
[ ]Comments
Test: Neutrophils_PX608
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.gSponsor ID: Not Applicable
[ ]Comments
Test: Eosinophils_PX609
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824846
Page 52 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.hSponsor ID: Not Applicable
[ ]Comments
Test: Monocytes_PX612
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
5.iSponsor ID: Not Applicable
[ ]Comments
Test: Basophils_PX610
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824847
Page 53 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.jSponsor ID: Not Applicable
[ ]Comments
Test: Lymphocytes_PX611
Result: Not Applicable
[ ]Comments
Not Done: Not Applicable Comments
LNMT Not Applicable
Low
[ ]
High
[ ]
UnitComments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824848
Page 54 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Systolic: Diastolic:
Not Applicable  Not Applicable  Not Applicable Repeating Pages
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824849
Page 55 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Systolic: Not Applicable
[ ]Comments
Diastolic: Not Applicable
[ ]Comments
Respiratory Rate in
respirations/minute:Not Applicable
[ ]Comments
Heart Rate in beats/minute: Not Applicable
[ ]Comments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824850
Page 56 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Date: Vital Signs Details Form Instance
 1.Not Applicable Record Identifier: Oxygen Saturation
Not Applicable  Not Applicable Repeating Pages
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824851
Page 57 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
SPO2 Pulse Oximetry % Not Applicable
[ ]Comments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824852
Page 58 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824853
Page 59 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Oxygenation Parameters
1.Date Time of Assessment: Not Applicable
//Comments
2.Arterial Blood Gases PaO2
(mmHg):Not Applicable
[ ]Comments
3.FiO2 (Fraction of Inhaled Oxygen): Not Applicable
[ ]Comments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824854
Page 60 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824855
Page 61 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824856
Page 62 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Repeating Pages
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824857
Page 63 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
Form Comments
eCRF Audit Trail History
Imaging
1.Date of Assessment: Not Applicable
//Comments
2.Location of Assessment: Not Applicable Comments
3.Type of Imaging Exam: Not Applicable Comments
4.Assessment: Not Applicable Comments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824858
Page 64 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/02/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/2/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824859
Page 65 of 392
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Mar/02/2021Form: 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: 12201020 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:
Mar/2/2021
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 [BR8P9R]
5.bSample ID [BS711J]
5.cSample ID [BS7108]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824860
Page 66 of 392
***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: 12201020 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:
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824861
Page 67 of 392
***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: 12201020 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 [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824862
Page 68 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  diarrhea  Oct/17/2020 07:3
0 NO
End Date Time:
Oct/19/2020 07:30
 Repeating
Pages
 2.ADVERSE E
VENT 2  Exposure during Pregnanc
y Oct/23/2020 UN
K:UNK NO
End Date Time:
Dec/16/2020 UNK:UN
K
 Repeating
Pages
 3.ADVERSE E
VENT 3  Soreness at Injection site (l
eft deltoid) Nov/7/2020 06:0
0 NO
End Date Time:
Nov/9/2020 14:00
 Repeating
Pages
 4.ADVERSE E
VENT 4  Headache  Nov/7/2020 06:0
0 NO
End Date Time:
Nov/7/2020 23:59
 Repeating
Pages
 5.ADVERSE E
VENT 5  Vomiting  Nov/7/2020 06:0
0 NO
End Date Time:
Nov/7/2020 23:59
 Repeating
Pages
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824863
Page 69 of 392
***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: 12201020 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)[diarrhea]
4.Start Date Time: Oct/17/2020 07:30
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/19/2020 07:30
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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824864
Page 70 of 392
***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: 12201020 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[ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824865
Page 71 of 392
***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: 12201020 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)[Exposure during Pregnancy]
4.Start Date Time: Oct/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/16/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unprotected heterosexual intercourse]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824866
Page 72 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824867
Page 73 of 392
***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: 12201020 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 (left deltoid)]
4.Start Date Time: Nov/7/2020 06:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/9/2020 14:00
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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824868
Page 74 of 392
***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: 12201020 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[ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824869
Page 75 of 392
***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: 12201020 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: Nov/7/2020 06:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/7/2020 23:59
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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824870
Page 76 of 392
***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: 12201020 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[ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824871
Page 77 of 392
***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: 12201020 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)[Vomiting]
4.Start Date Time: Nov/7/2020 06:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/7/2020 23:59
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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824872
Page 78 of 392
***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: 12201020 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[ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824873
Page 79 of 392
***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: 12201020 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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824874
Page 80 of 392
***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: 12201020 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[ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824875
Page 81 of 392
***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: 12201020 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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824876
Page 82 of 392
***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: 12201020 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: //
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824877
Page 83 of 392
***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: 12201020 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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824878
Page 84 of 392
***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: 12201020 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?
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824879
Page 85 of 392
***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: 12201020 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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824880
Page 86 of 392
***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: 12201020 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?
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824881
Page 87 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824882
Page 88 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824883
Page 89 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824884
Page 90 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Unplanned Assessments
1.Assessments
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824885
Page 91 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824886
Page 92 of 392
***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: 12201020 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:
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824887
Page 93 of 392
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824888
Page 94 of 392
***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: 12201020 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?
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824889
Page 95 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824890
Page 96 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824891
Page 97 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824892
Page 98 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824893
Page 99 of 392
***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: 12201020 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 [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824894
Page 100 of 392
***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: 12201020 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 [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824895
Page 101 of 392
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/4/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824896
Page 102 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824897
Page 103 of 392
***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: 12201020 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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824898
Page 104 of 392
***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: 12201020 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: [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824899
Page 105 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/17/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824900
Page 106 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824901
Page 107 of 392
***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: 12201020 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: [ ]
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824902
Page 108 of 392
***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: 12201020 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 Dec/4/2020
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824903
Page 109 of 392
***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: 12201020 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
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4)
FDA-CBER-2021-5683-0824904
Page 110 of 392
***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: 12201020 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-09-2021 14:56:57 (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.
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0824905
Page 111 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormOct-16-2020 12:59:29 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824906
Page 112 of 392
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aOct-16-2020 14:55:17 (UTC-07:00) Mountain
Time (US & Canada)Send-Serum
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824907
Page 113 of 392
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bOct-16-2020 14:55:33 (UTC-07:00) Mountain
Time (US & Canada)Retain-Serum
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824908
Page 114 of 392
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cOct-16-2020 14:55:47 (UTC-07:00) Mountain
Time (US & Canada)Retain-Serum
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824909
Page 115 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aDec-04-2020 16:05:09 (UTC-07:00) Mountain
Time (US & Canada)Retain-Serum
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824910
Page 116 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bDec-04-2020 16:05:43 (UTC-07:00) Mountain
Time (US & Canada)Retain-Serum
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824911
Page 117 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cDec-04-2020 16:06:24 (UTC-07:00) Mountain
Time (US & Canada)Send-Serum
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824912
Page 118 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-11-2021 12:25:18 (UTC-07:00) Mountain
Time (US & Canada)Subject did not seek medical care and not tested
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824913
Page 119 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-11-2021 12:25:18 (UTC-07:00) Mountain
Time (US & Canada)Subject did not seek medical care and not tested
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824914
Page 120 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-11-2021 12:25:18 (UTC-07:00) Mountain
Time (US & Canada)Subject did not seek medical care and not tested
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824915
Page 121 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-11-2021 12:25:18 (UTC-07:00) Mountain
Time (US & Canada)Subject did not seek medical care and not tested
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824916
Page 122 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-11-2021 12:25:18 (UTC-07:00) Mountain
Time (US & Canada)Subject did not seek medical care and not tested
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824917
Page 123 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Jan-11-2021 12:25:18 (UTC-07:00) Mountain
Time (US & Canada)Subject did not seek medical care and not tested
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824918
Page 124 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Jan-11-2021 12:25:18 (UTC-07:00) Mountain
Time (US & Canada)Subject did not seek medical care and not tested
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824919
Page 125 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
7Jan-11-2021 12:25:18 (UTC-07:00) Mountain
Time (US & Canada)Subject did not seek medical care and not tested
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824920
Page 126 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
8Jan-11-2021 12:25:18 (UTC-07:00) Mountain
Time (US & Canada)Subject did not seek medical care and not tested
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824921
Page 127 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
9Jan-11-2021 12:25:18 (UTC-07:00) Mountain
Time (US & Canada)Subject did not seek medical care and not tested
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824922
Page 128 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-15-2021 09:09:41 (UTC-07:00) Mountain
Time (US & Canada)
FormJan-11-2021 12:31:09 (UTC-07:00) Mountain
Time (US & Canada)Subject self swabbed
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824923
Page 129 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-15-2021 09:09:41 (UTC-07:00) Mountain
Time (US & Canada)
1Jan-11-2021 12:31:09 (UTC-07:00) Mountain
Time (US & Canada)Subject self swabbed
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824924
Page 130 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-15-2021 09:09:41 (UTC-07:00) Mountain
Time (US & Canada)
2Jan-11-2021 12:31:09 (UTC-07:00) Mountain
Time (US & Canada)Subject self swabbed
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824925
Page 131 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-19-2021 13:33:17 (UTC-07:00) Mountain
Time (US & Canada)A self swab was completed by Participant.
3Jan-15-2021 09:11:53 (UTC-07:00) Mountain
Time (US & Canada)A self swab was completed by Participant.
Not Applicable
3Jan-15-2021 09:09:41 (UTC-07:00) Mountain
Time (US & Canada)
3Jan-11-2021 12:31:09 (UTC-07:00) Mountain
Time (US & Canada)Subject self swabbed
Not Done
090177e196ae30ce\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-2021-5683-0824926
Page 132 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-15-2021 09:09:41 (UTC-07:00) Mountain
Time (US & Canada)
4Jan-11-2021 12:31:09 (UTC-07:00) Mountain
Time (US & Canada)Subject self swabbed
Not Done
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824927
Page 133 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-11-2021 12:34:26 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824928
Page 134 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-11-2021 12:34:26 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824929
Page 135 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-11-2021 12:34:26 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824930
Page 136 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-11-2021 12:34:26 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824931
Page 137 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-11-2021 12:34:26 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824932
Page 138 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Jan-11-2021 12:34:26 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824933
Page 139 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Jan-11-2021 12:34:26 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824934
Page 140 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-11-2021 12:33:07 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824935
Page 141 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-11-2021 12:33:07 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824936
Page 142 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-11-2021 12:33:07 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824937
Page 143 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-11-2021 12:33:07 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824938
Page 144 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-11-2021 12:33:07 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824939
Page 145 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824940
Page 146 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824941
Page 147 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824942
Page 148 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824943
Page 149 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
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Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824949
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824950
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824951
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824952
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824953
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824954
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824955
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824956
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824957
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824958
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824959
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824960
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824961
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824962
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824963
Page 169 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824964
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824965
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824966
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824967
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824968
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824969
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824970
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824971
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY -
Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-11-2021 12:33:57 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824972
Page 178 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824973
Page 179 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824974
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824975
Page 181 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824976
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***Confidential***
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Visit: POT_COVID_ILL 1 - Unscheduled Visit
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Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824977
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***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824978
Page 184 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824979
Page 185 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824980
Page 186 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.aJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824981
Page 187 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824982
Page 188 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824983
Page 189 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824984
Page 190 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.bJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824985
Page 191 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824986
Page 192 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824987
Page 193 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824988
Page 194 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.cJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824989
Page 195 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824990
Page 196 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824991
Page 197 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824992
Page 198 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.dJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824993
Page 199 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824994
Page 200 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824995
Page 201 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824996
Page 202 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.eJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824997
Page 203 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824998
Page 204 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0824999
Page 205 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825000
Page 206 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 fJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825001
Page 207 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825002
Page 208 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825003
Page 209 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825004
Page 210 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.gJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825005
Page 211 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825006
Page 212 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825007
Page 213 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825008
Page 214 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5 hJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825009
Page 215 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825010
Page 216 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825011
Page 217 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825012
Page 218 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.iJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825013
Page 219 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825014
Page 220 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825015
Page 221 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825016
Page 222 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Comments
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5.jJan-11-2021 12:34:44 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825017
Page 223 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-11-2021 12:35:05 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825018
Page 224 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-11-2021 12:35:05 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825019
Page 225 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aJan-11-2021 12:35:05 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825020
Page 226 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aJan-11-2021 12:35:05 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825021
Page 227 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aJan-11-2021 12:35:05 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825022
Page 228 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: VITAL SIGNS - COVID - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aJan-11-2021 12:35:05 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825023
Page 229 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-11-2021 12:35:24 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825024
Page 230 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-11-2021 12:35:24 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825025
Page 231 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: VITAL SIGNS - PULSE OX ROOM AIR - Comments
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2.aJan-11-2021 12:35:24 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825026
Page 232 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-11-2021 12:35:56 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825027
Page 233 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-11-2021 12:35:56 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825028
Page 234 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-11-2021 12:35:56 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825029
Page 235 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-11-2021 12:35:56 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825030
Page 236 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-11-2021 12:36:16 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825031
Page 237 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-11-2021 12:36:16 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825032
Page 238 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-11-2021 12:36:16 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825033
Page 239 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-11-2021 12:36:16 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825034
Page 240 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-11-2021 12:36:16 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825035
Page 241 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
5Jan-11-2021 12:36:16 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825036
Page 242 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
6Jan-11-2021 12:36:16 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825037
Page 243 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
FormJan-11-2021 12:36:36 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825038
Page 244 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
1Jan-11-2021 12:36:36 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825039
Page 245 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
2Jan-11-2021 12:36:36 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825040
Page 246 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
3Jan-11-2021 12:36:36 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825041
Page 247 of 392
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/07/2021Form: IMAGING - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
ItemDate User Comment
4Jan-11-2021 12:36:36 (UTC-07:00) Mountain
Time (US & Canada)Not Applicable
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0825042
Page 248 of 392
***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: 12201020 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-09-2021 14:56:57 (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-18-2021 16:08:26 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit  Approved Jan-23-2021 08:00:51 (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-15-2021 09:09:41 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit  Approved Jan-12-2021 21:35:12 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825043
Page 249 of 392
***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: 12201020 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 Jan-11-2021 12:25:18 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Laura Hammit  Approved Jan-11-2021 09:45:21 (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.
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825044
Page 250 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-30-2020 15:53:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Transcription Error
Oct-16-2020 12:58:37
(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
Oct-16-2020 12:58:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30ce\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-2021-5683-0825045
Page 251 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-16-2020 12:58:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/16/2020Initial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825046
Page 252 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-16-2020 12:58:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12201020Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-16-2020 12:58:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1994Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-16-2020 12:59:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-16-2020 12:59:01
(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
Oct-16-2020 12:59:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AMERICAN INDIAN OR ALAS
KA NATIVEInitial Entry
090177e196ae30ce\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-2021-5683-0825047
Page 253 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020 12:59:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825048
Page 254 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-16-2020 13:00:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020 13:00:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020 13:00:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825049
Page 255 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1.a
Date Location User Value Reason
Oct-16-2020 13:10:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Admission for labor
and delivery
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-16-2020 13:10:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 13:10:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Admission for labor and deliveryInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-16-2020 13:10:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-16-2020 13:10:48
(UTC-07:00) MountainACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0825050
Page 256 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada) End Date:
UNK/UNK/2014
1.b
Date Location User Value Reason
Oct-16-2020 13:11:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:uncomplicated kid
ney stones
Start Date: Aug/13/2020
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Oct-16-2020 13:11:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 13:11:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
uncomplicated kidney stonesInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-16-2020 13:11:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-16-2020 13:11:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30ce\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-2021-5683-0825051
Page 257 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.c
Date Location User Value Reason
Oct-16-2020 13:12:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:chlamydia infec
tion
Start Date: Mar/13/2020
Ongoing: NO
End Date:
Mar/17/2020Initial Entry
1.c Line/MH Number:
Date Location User Value Reason
Oct-16-2020 13:12:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 13:12:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
chlamydia infectionInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-16-2020 13:12:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/13/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-16-2020 13:12:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Mar/17/2020Initial Entry
090177e196ae30ce\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-2021-5683-0825052
Page 258 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
1.d
Date Location User Value Reason
Oct-16-2020 13:12:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:chlamydia infec
tion
Start Date: Jun/17/2011
Ongoing: NO
End Date:
Jun/17/2011Initial Entry
1.d Line/MH Number:
Date Location User Value Reason
Oct-16-2020 13:12:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-16-2020 13:12:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
chlamydia infectionInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-16-2020 13:12:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/17/2011Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-16-2020 13:12:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/17/2011Initial Entry
090177e196ae30ce\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-2021-5683-0825053
Page 259 of 392
***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: 12201020 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
Oct-16-2020 13:00:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825054
Page 260 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020 13:02:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-16-2020 13:02:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
199.6Initial Entry
3. Unit:
Date Location User Value Reason
Oct-16-2020 13:02:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-16-2020 13:02:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
62.5Initial Entry
5. Unit:
Date Location User Value Reason
Oct-16-2020 13:02:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-16-2020 13:02:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35.9Initial Entry
090177e196ae30ce\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-2021-5683-0825055
Page 261 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7.a
Date Location User Value Reason
Oct-16-2020 13:02:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.0
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-16-2020 13:02:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-16-2020 13:02:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-16-2020 13:02:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-16-2020 13:02:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae30ce\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-2021-5683-0825056
Page 262 of 392
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-16-2020 13:00:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-16-2020 13:00:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-16-2020 13:00:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-16-2020 13:00:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-16-2020 13:00:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-16-2020 13:00:52
(UTC-07:00) MountainACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825057
Page 263 of 392
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1220 Site Name: (1220) Shiprock Center for American Indian Health
Subject No: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-16-2020 13:00:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-16-2020 13:00:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-16-2020 13:00:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825058
Page 264 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-16-2020 14:01:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-16-2020 14:01:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Transcription Error
Oct-16-2020 13:59:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Randomization Date
16/Sep/2020 is
before or more than
1 day after
corresponding Date
of Visit 16/Oct/2020.
Please review and
update as
appropriate.
Oct-16-2020 13:59:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-16-2020 13:59:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
109218Initial Entry
090177e196ae30ce\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-2021-5683-0825059
Page 265 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 13:08:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 13:08:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 14:54:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 13:08:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 13:08:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020 14:54:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8P5GInitial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825060
Page 266 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 14:54:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8P5GInitial Entry
5.b
Date Location User Value Reason
Oct-16-2020 14:54:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS70HJInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-16-2020 14:54:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS70HJInitial Entry
5.c
Date Location User Value Reason
Oct-16-2020 14:54:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS70HXInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-16-2020 14:54:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS70HXInitial Entry
090177e196ae30ce\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-2021-5683-0825061
Page 267 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 13:02:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 13:02:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-16-2020 14:54:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-16-2020 13:02:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-16-2020 13:02:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
5.a
Date Location User Value Reason
Oct-16-2020 14:54:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8PHYInitial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825062
Page 268 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
5.a Sample ID
Date Location User Value Reason
Oct-16-2020 14:54:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8PHYInitial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0825063
Page 269 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-16-2020 14:02:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-16-2020 14:02:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-16-2020 14:02:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-16-2020 14:02:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020 13:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-16-2020 14:02:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-16-2020 14:02:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae30ce\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-2021-5683-0825064
Page 270 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
7. Route:
Date Location User Value Reason
Oct-16-2020 14:02:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-16-2020 14:02:25
(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
Oct-16-2020 14:02:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825065
Page 271 of 392
***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: 12201020 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-16-2020 13:00:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825066
Page 272 of 392
***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: 12201020 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-06-2020 11:37:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/6/2020Initial Entry
090177e196ae30ce\Final\Final On: 01-Apr-2021 04:17 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0825067
Page 273 of 392
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 
…[truncated]