Document text
Page 1 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982526
Page 2 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/29/2020
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982527
Page 3 of 150
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11361102]
2.Birth Date: /1944
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982528
Page 4 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982529
Page 5 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982530
Page 6 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982531
Page 7 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bilateral hearing loss]
Start Date: UNK/UNK/1957
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[congenital heart defect]
Start Date: UNK/UNK/1944
Ongoing: NO
End Date:
UNK/UNK/1949
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendicitis]
Start Date: UNK/UNK/1954
Ongoing: NO
End Date:
UNK/UNK/1954
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendectomy]
Start Date: UNK/UNK/1954
Ongoing: NO
End Date:
UNK/UNK/1954
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982532
Page 8 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[patent ductus arteriosus heart surgery]
Start Date: UNK/UNK/1947
Ongoing: NO
End Date:
UNK/UNK/1947
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[patent ductus arteriosus heart surgery]
Start Date: UNK/UNK/1949
Ongoing: NO
End Date:
UNK/UNK/1949
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982533
Page 9 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982534
Page 10 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/29/2020
2.Weight: [132.0]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [20.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982535
Page 11 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/29/2020
2.Randomization Number: [273737]
3.Randomization Group: [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982536
Page 12 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
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 [BM91XN]
5.bSample ID [BM91XP]
5.cSample ID [BM91XR]
5.dSample ID [BPRSPD]
5.eSample ID [BPRSPF]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982537
Page 13 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
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 [BM91VS]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982538
Page 14 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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/29/2020 12:21
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982539
Page 15 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982540
Page 16 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982541
Page 17 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Nov/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982542
Page 18 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/19/2020
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 [BRFWWL]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982543
Page 19 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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/19/2020 12:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982544
Page 20 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982545
Page 21 of 150
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982546
Page 22 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982547
Page 23 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982548
Page 24 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982549
Page 25 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982550
Page 26 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982551
Page 27 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982552
Page 28 of 150
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982553
Page 29 of 150
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982554
Page 30 of 150
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982555
Page 31 of 150
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982556
Page 32 of 150
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982557
Page 33 of 150
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982558
Page 34 of 150
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982559
Page 35 of 150
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982560
Page 36 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982561
Page 37 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982562
Page 38 of 150
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 sore in injection site, ri
ght arm Oct/29/2020 00
:00 NO
End Date Time:
Oct/29/2020 00:00
Repeating
Pages
2.ADVERSE EV
ENT 2 cardiac arrest Dec/19/2020 0
0:00 NO
End Date Time:
Dec/19/2020 00:00
Repeating
Pages
3.ADVERSE EV
ENT 3 injection site pain, right
Nov/20/2020 0
0:00 NO
End Date Time:
Nov/21/2020 00:00
Repeating
Pages
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982563
Page 39 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[sore in injection site, right arm]
4.Start Date Time: Oct/29/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/29/2020 00:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982564
Page 40 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982565
Page 41 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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)[cardiac arrest]
4.Start Date Time: Dec/19/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/19/2020 00:00
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982566
Page 42 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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:
[cardiac related]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2021195041]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982567
Page 43 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site pain, right]
4.Start Date Time: Nov/20/2020 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/21/2020 00:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982568
Page 44 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982569
Page 45 of 150
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982570
Page 46 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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[ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982571
Page 47 of 150
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982572
Page 48 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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: //
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982573
Page 49 of 150
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982574
Page 50 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982575
Page 51 of 150
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982576
Page 52 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982577
Page 53 of 150
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982578
Page 54 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982579
Page 55 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982580
Page 56 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982581
Page 57 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982582
Page 58 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982583
Page 59 of 150
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982584
Page 60 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982585
Page 61 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982586
Page 62 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982587
Page 63 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982588
Page 64 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982589
Page 65 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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 [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982590
Page 66 of 150
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/19/2020
2.Phase of Disposition: VACCINATION
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982591
Page 67 of 150
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982592
Page 68 of 150
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982593
Page 69 of 150
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Dec/19/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982594
Page 70 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982595
Page 71 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982596
Page 72 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Jan/22/2021
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Cardiac arrest]
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982597
Page 73 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Dec/19/2020
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982598
Page 74 of 150
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Casebook Signature Form
1.Casebook Signature
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982599
Page 75 of 150
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982600
Page 76 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormNov-02-2020 14:18:18 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982601
Page 77 of 150
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormMar-05-2021 12:37:42 (UTC-08:00) Pacific
Time (US & Canada)Subject is deceased.
Not Done
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982602
Page 78 of 150
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Mar-05-2021 12:37:42 (UTC-08:00) Pacific Time
(US & Canada)Subject is deceased.
Not Done
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982603
Page 79 of 150
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Mar-05-2021 12:37:42 (UTC-08:00) Pacific Time
(US & Canada)Subject is deceased.
Not Done
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982604
Page 80 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormFeb-05-2021 11:16:45 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982605
Page 81 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Feb-05-2021 11:16:45 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982606
Page 82 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Feb-05-2021 11:16:45 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982607
Page 83 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormFeb-05-2021 11:17:11 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982608
Page 84 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Feb-05-2021 11:17:11 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982609
Page 85 of 150
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982610
Page 86 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Nov-02-2020 13:58:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Nov-02-2020 13:58:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982611
Page 87 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Nov-02-2020 13:58:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/29/2020Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982612
Page 88 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-02-2020 14:15:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-02-2020 14:15:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
11361102Transcription Error
Nov-02-2020 14:00:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Subject ID is
expected to be in 8
digits composed of 4
digits site number
and sequential 4
digits subject
number. Please
review.
Nov-02-2020 13:58:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1136102Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Nov-02-2020 13:58:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1944Enrollment Entry
3. Sex:
Date Location User Value Reason
Nov-02-2020 14:00:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Nov-02-2020 14:00:06
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(A)Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982613
Page 89 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada) OR OF SPANISH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Nov-05-2020 13:03:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-04-2020 15:33:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Nov-04-2020 15:33:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITETranscription Error
Nov-03-2020 11:34:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY: NOT
REPORTED is
selected for RACE.
Please clarify if this
information can be
obtained and update
the CRF if
applicable.
Nov-02-2020 14:00:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT REPORTEDInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982614
Page 90 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020 14:18:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982615
Page 91 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Nov-02-2020 14:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-02-2020 14:18:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Nov-02-2020 14:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982616
Page 92 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Nov-02-2020 14:25:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:bilateral hearin
g loss
Start Date: UNK/UNK/195
7
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-02-2020 14:25:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-02-2020 14:25:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
bilateral hearing lossInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-02-2020 14:25:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1957Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-02-2020 14:25:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982617
Page 93 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b
Date Location User Value Reason
Nov-02-2020 14:26:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:congenital heart
defect
Start Date: UNK/UNK/1944
Ongoing: NO
End Date:
UNK/UNK/1
949Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982618
Page 94 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Line/MH Number:
Date Location User Value Reason
Nov-02-2020 14:26:53
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-02-2020 14:26:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
congenital heart defectInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-02-2020 14:26:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1944Initial Entry
1.b Ongoing:
Date Location User Value Reason
Nov-02-2020 14:26:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1949Initial Entry
1.c
Date Location User Value Reason
Nov-02-2020 14:27:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:appendicitis
Start Date: UNK/UNK/195
4Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982619
Page 95 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Ongoing: NO
End Date:
UNK/UNK/
1954
1.c Line/MH Number:
Date Location User Value Reason
Nov-02-2020 14:27:43
(UTC-08:00) Pacific 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
Nov-02-2020 14:27:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
appendicitisInitial Entry
1.c Start Date:
Date Location User Value Reason
Nov-02-2020 14:27:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1954Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-02-2020 14:27:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1954Initial Entry
1.d
Date Location User Value Reason
Nov-02-2020 14:29:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982620
Page 96 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Medical History
Term:appendectomy
Start Date: UNK/UNK/195
4
Ongoing: NO
End Date:
UNK/UNK/
1954
1.d Line/MH Number:
Date Location User Value Reason
Nov-02-2020 14:29:05
(UTC-08:00) Pacific 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
Nov-02-2020 14:29:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
appendectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Nov-02-2020 14:29:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1954Initial Entry
1.d Ongoing:
Date Location User Value Reason
Nov-02-2020 14:29:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1954Initial Entry
1.e
Date Location User Value Reason
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982621
Page 97 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-06-2020 12:08:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:5
Medical Hi
story Term:patent ductus arteri
osus heart surgery
Start Date: UNK/UNK/1947
Ongoing: NO
End Date:
UNK/UNK/194
7Changed
Information
Nov-02-2020 14:30:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Histo
ry Term:patent ductus hea
rt surgery
Start Date: UNK/UNK/1947
Ongoing: NO
End Date:
UNK/UNK/1
947Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982622
Page 98 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Line/MH Number:
Date Location User Value Reason
Nov-02-2020 14:30:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-06-2020
16:50:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Close
dDiscrepancy has
been closed.
Nov-06-2020
12:08:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answ
eredChanged
Information
Nov-06-2020
12:08:04
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
patent ductus a
rteriosus heart
surgeryChanged
Information
Nov-03-2020
03:15:53
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Open
edClarify PATENT
DUCTUS
HEART
SURGERY as
follows...The
term appears
incomplete. Are
you reporting
PATENT
DUCTUS
ARTERIOSUS
HEART
SURGERY? If
so, update the
verbatim term as
such. Otherwise
clarify and edit
the term. Thank
you.
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982623
Page 99 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-02-2020
14:30:54
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
patent ductus h
eart surgeryInitial Entry
1.e Start Date:
Date Location User Value Reason
Nov-02-2020 14:30:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1947Initial Entry
1.e Ongoing:
Date Location User Value Reason
Nov-02-2020 14:30:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1947Initial Entry
1.f
Date Location User Value Reason
Nov-06-2020 12:08:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:6
Medical Hi
story Term:patent ductus arteri
osus heart surgery
Start Date: UNK/UNK/1949
Ongoing: NO
End Date:
UNK/UNK/194
9Changed
Information
Nov-02-2020 14:31:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Histo
ry Term:patent ductus hea
rt surgery
Start Date: UNK/UNK/1949Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982624
Page 100 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Ongoing: NO
End Date:
UNK/UNK/1
949
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982625
Page 101 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.f Line/MH Number:
Date Location User Value Reason
Nov-02-2020 14:31:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-06-2020
16:50:45
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Close
dDiscrepancy has
been closed.
Nov-06-2020
12:08:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answ
eredChanged
Information
Nov-06-2020
12:08:26
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
patent ductus a
rteriosus heart
surgeryChanged
Information
Nov-03-2020
03:16:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: Open
edClarify PATENT
DUCTUS
HEART
SURGERY as
follows...The
term appears
incomplete. Are
you reporting
PATENT
DUCTUS
ARTERIOSUS
HEART
SURGERY? If
so, update the
verbatim term as
such. Otherwise
clarify and edit
the term. Thank
you.
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982626
Page 102 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-02-2020
14:31:50
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
patent ductus h
eart surgeryInitial Entry
1.f Start Date:
Date Location User Value Reason
Nov-02-2020 14:31:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1949Initial Entry
1.f Ongoing:
Date Location User Value Reason
Nov-02-2020 14:31:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1949Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982627
Page 103 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Nov-02-2020 14:19:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be H
IV POSITIVEInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982628
Page 104 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Nov-02-2020 14:21:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
2. Weight:
Date Location User Value Reason
Nov-02-2020 14:21:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
132.0Initial Entry
3. Unit:
Date Location User Value Reason
Nov-02-2020 14:21:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Nov-02-2020 14:21:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
68.0Initial Entry
5. Unit:
Date Location User Value Reason
Nov-02-2020 14:21:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Nov-02-2020 14:21:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20.1Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982629
Page 105 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7.a
Date Location User Value Reason
Nov-02-2020 14:21:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.8
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Nov-02-2020 14:21:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Nov-02-2020 14:21:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.8Initial Entry
7.a Unit:
Date Location User Value Reason
Nov-02-2020 14:21:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Nov-02-2020 14:21:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982630
Page 106 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Nov-02-2020 14:21:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Nov-02-2020 14:21:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
273737Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982631
Page 107 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020 14:22:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020 14:22:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020 14:57:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-02-2020 14:22:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-02-2020 14:22:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020 14:57:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM91XNInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982632
Page 108 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Nov-02-2020 14:57:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM91XNInitial Entry
5.b
Date Location User Value Reason
Nov-02-2020 14:57:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM91XPInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-02-2020 14:57:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM91XPInitial Entry
5.c
Date Location User Value Reason
Nov-02-2020 14:57:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM91XRInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-02-2020 14:57:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM91XRInitial Entry
5.d
Date Location User Value Reason
Jan-22-2021 10:42:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRSPDInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982633
Page 109 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Jan-22-2021 10:42:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRSPDInitial Entry
5.e
Date Location User Value Reason
Jan-22-2021 10:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRSPFInitial Entry
5.e Sample ID
Date Location User Value Reason
Jan-22-2021 10:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRSPFInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982634
Page 110 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020 14:22:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020 14:22:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-02-2020 14:58:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-02-2020 14:22:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-02-2020 14:22:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
Nov-02-2020 14:58:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM91VSInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982635
Page 111 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Nov-02-2020 14:58:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM91VSInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982636
Page 112 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-02-2020 14:23:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-02-2020 14:23:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-02-2020 14:23:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-02-2020 14:23:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/29/2020 12:21Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-02-2020 14:23:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-02-2020 14:23:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982637
Page 113 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Nov-02-2020 14:23:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-02-2020 14:23:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-02-2020 14:23:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982638
Page 114 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Nov-02-2020 14:24:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982639
Page 115 of 150
***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: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-20-2020 09:19:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/19/2020Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982640
Page 116 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Nov-20-2020 09:22:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/19/2020Initial Entry
2.a
Date Location User Value Reason
Nov-20-2020 09:22:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.2
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-20-2020 09:22:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-20-2020 09:22:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-20-2020 09:22:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982641
Page 117 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-20-2020 09:22:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982642
Page 118 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-20-2020 09:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-20-2020 09:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-20-2020 14:43:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-20-2020 09:23:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-20-2020 09:23:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/19/2020Initial Entry
5.a
Date Location User Value Reason
Nov-20-2020 14:43:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRFWWLInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982643
Page 119 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Sample ID
Date Location User Value Reason
Nov-20-2020 14:43:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRFWWLInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982644
Page 120 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-20-2020 09:24:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-20-2020 09:24:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-20-2020 09:24:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-20-2020 09:24:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/19/2020 12:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-20-2020 09:24:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-20-2020 09:24:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982645
Page 121 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7. Route:
Date Location User Value Reason
Nov-20-2020 09:24:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-20-2020 09:24:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-20-2020 09:24:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982646
Page 122 of 150
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-05-2021 12:37:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-05-2021 12:37:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982647
Page 123 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982648
Page 124 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-18-2021 08:39:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982649
Page 125 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982650
Page 126 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
sore in injection site, right armInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/29/2020 00:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/29/2020 00:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982651
Page 127 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-20-2020 09:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982652
Page 128 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-20-2020 09:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982653
Page 129 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-18-2021 08:39:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-18-2021 08:39:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cardiac arrestInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/19/2020 00:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-02-2021 14:44:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed have requested EOT be
unfrozen and reissued query
on EOT. FUP is unfrozen
and has similar query
already
Mar-01-2021 16:05:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Please unfreeze CRF pages
so data may been changed
as requested.
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0982654
Page 130 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-18-2021 14:39:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY: the end date
of the AE cardiac arrest is
19/Dec/2020 00:00. Please
clarify if the date of death
on the DISPOSITION
TREATMENT and
DISPOSITION
FOLLOW-UP CRFs (Date
of
Completion/Discontinuation
/Death) should be updated
to 19Dec2020.
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/19/2020 00:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-09-2021 02:45:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Mar-08-2021 16:18:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Follow up SAE form
has been faxed in to
Safety.
Feb-23-2021 18:17:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Deleted Close Auto Query
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982655
Page 131 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-23-2021 11:44:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Reissued:Opened SAE RECON1:
Thanks for the
response. SAE is
missing in safety
database. If event is
serious, Confirm
submission of follow
up SAE form. If this
event is not serious,
downgrade the event
on AE CRF.
Feb-22-2021 18:36:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 2: Closed Response satisfies
query
Feb-22-2021 10:34:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Candidate For AE cardiac arrest:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-22-2021 10:34:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Changed Information
Feb-22-2021 10:34:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed Information
Feb-22-2021 10:34:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
YES
Did this serious event require o
r prolong hospitalization?
NOChanged Information
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982656
Page 132 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
NO
Feb-21-2021 18:39:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened SAE RECON: ca is
not reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Feb-21-2021 18:38:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
Feb-21-2021 13:33:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Quan Jason
GongQuery 2: Opened GPDClin: If the SAE
was fatal, then "result
in persistent or
significant
disability/incapacity"
is not applicable,
please consider
change the answer to
"No" for that criterion.
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE cardiac arrest:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982657
Page 133 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
blank.
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
YES
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
YES
Is this serious event life threate
ning?
YES
Other medically important seri
ous event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982658
Page 134 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Mar-09-2021 14:17:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Juleen Gayed Query 1: Closed Response satisfies
query
Mar-08-2021 15:31:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Data has been
changed on follow
up SAE form.
Mar-07-2021 04:10:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Juleen Gayed Query 1: Opened Clin: SAE report
submitted states
cause of death was
disease progression,
please confirm what
if this is correct as
cause of death is
cardiac arrest and
send updated SAE
report to clarify
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
cardiac relatedInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982659
Page 135 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FATALInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-18-2021 08:39:40
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-23-2021 18:17:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
2021195041Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982660
Page 136 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
injection site pain, rightInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/20/2020 00:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Nov/21/2020 00:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982661
Page 137 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-18-2021 08:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) PacificACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982662
Page 138 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-18-2021 08:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982663
Page 139 of 150
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-08-2021 05:32:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Mar-05-2021 12:49:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Mar-05-2021 12:49:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/19/2020Changed Information
Mar-02-2021 22:52:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY: the end date
of the AE cardiac arrest is
19/Dec/2020 00:00. Please
clarify if the date of death
on the DISPOSITION
TREATMENT and
DISPOSITION
FOLLOW-UP CRFs (Date
of
Completion/Discontinuation
/Death) should be updated
to 19Dec2020.
Mar-02-2021 14:42:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Candidate CLINQUERY: the end date
of the AE cardiac arrest is
19/Dec/2020 00:00. Please
clarify if the date of death
on the DISPOSITION
TREATMENT and
DISPOSITION
FOLLOW-UP CRFs (Date
of
Completion/Discontinuation
/Death) should be updated
to 19Dec2020.
Feb-16-2021 13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982664
Page 140 of 150
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2. Phase of Disposition:
Date Location User Value Reason
Feb-16-2021 13:45:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User ValueReason
Feb-18-2021
12:01:05
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Rivkah Rosen Query
1: Clo
sedResponse satisfies
query
Feb-18-2021
08:44:34
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dChanged data per query
Feb-16-2021
20:58:39
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7276530;DEATH
is selected for 'Status',
but there is no Adverse
Event with a outcome
of FATAL. Please
review and update as
appropriate.
Feb-16-2021
13:45:10
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
DEAT
HInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982665
Page 141 of 150
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-07-2021 22:52:08
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-05-2021 12:48:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Mar-05-2021 12:48:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/19/2020Transcription Error
Mar-02-2021 00:04:36
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened SAE RECON
1:Please confirm
correct date of death
.If CRF date
22Jan2021 is correct,
please submit a
follow up SAE form
update date of death
in Safety database.
Mar-01-2021 16:06:19
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Please advise how to
change data. There is
no form level button.
Feb-25-2021 21:28:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON:
AER#2021195041,
the date of death was
reported as
19Dec2020 in Safety
database but recorded
as 22Jan2021 in CRF.
Please confirm
correct date of death.
If safety update is
required, please
submit a follow-up
form.
Feb-16-2021 23:08:07
(UTC-08:00) PacificACV0PFEINFP6000 Query 1: Closed Response satisfies
query
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982666
Page 142 of 150
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Time (US & Canada)
Feb-16-2021 13:46:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-08-2021 00:19:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM 1: Thanks for
response. However,
Please review and
update EOT visit.
Else, clarify.
Feb-05-2021 11:18:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-03-2021 02:25:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Please update
EOT visit. Thank
you.
Jan-22-2021 09:45:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-22-2021 09:45:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User ValueReason
Feb-18-2021
12:01:27
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Rivkah Rosen Query
1: Clo
sedResponse satisfies
query
Feb-18-2021
08:45:14
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dChanged data per query
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982667
Page 143 of 150
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-24-2021
22:57:22
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW6957256;DEATH
is selected for 'Status',
but there is no Adverse
Event with a outcome
of FATAL. Please
review and update as
appropriate.
Jan-22-2021
09:45:24
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
DEAT
HInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982668
Page 144 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-05-2021 11:16:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-05-2021 11:16:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982669
Page 145 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Feb-05-2021 11:17:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982670
Page 146 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Mar-12-2021 23:31:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies query
Mar-08-2021 03:06:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 4: Reissued:Candida
teIssue added at QandA log.
Mar-05-2021 13:00:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered The site was notified on
22Jan2021 of the death.
Date of
collection/notification is
correct.
Mar-05-2021 12:48:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened Date of Collection /
Notification of Death is
greater than the Date of
Completion/Discontinuation
/Death on the Disposition
form 19/Dec/2020. Please
review and update as
appropriate
Feb-18-2021 14:35:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed will query regarding date of
death reported on
disposition forms vs the
stop of AE of cardiac arrest
Feb-18-2021 14:29:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies query
Feb-18-2021 08:43:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per query
Feb-17-2021 15:44:29
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Data has been completed.
Feb-10-2021 05:47:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened CLINQUERY: subject
appeared to have died prior
to visit 4. Please provide
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b)
(4),
(b) (6)
FDA-CBER-2021-5683-0982671
Page 147 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
adverse events that the
subject experienced, and
ensure at least 1 AE is
marked as an SAE that
resulted in death. Note:
PRIMARY CAUSE OF
DEATH is reported as
Cardiac arrest.
Feb-10-2021 05:46:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened CLINQUERY: Please
complete the disposition
treatment page (end of
treatment) for this subject
who received study
vaccinations. Note: Death
Details show PRIMARY
CAUSE OF DEATH as
Cardiac arrest.
Feb-09-2021 11:12:44
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 3: Candidate CLINQUERY: Please
complete the disposition
treatment page (end of
treatment) for this subject
who received study
vaccinations. Note: Death
Details show PRIMARY
CAUSE OF DEATH as
Cardiac arrest.
Feb-09-2021 11:06:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Candidate CLINQUERY: subject
appeared to have died prior
to visit 4. Please provide
adverse events that the
subject experienced, and
ensure at least 1 AE is
marked as an SAE that
resulted in death. Note:
PRIMARY CAUSE OF
DEATH is reported as
Cardiac arrest.
Feb-04-2021 22:47:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Feb-04-2021 09:28:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Data has been added
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0982672
Page 148 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Feb-04-2021 00:47:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R Query 1: Opened Please report cause of death
Jan-22-2021 09:44:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/22/2021Initial Entry
2.a
Date Location User Value Reason
Feb-04-2021 09:28:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cause of Dea
th Status:PRIMARY CAUS
E OF DEATH
Cause of Dea
th:Cardiac arrestInitial Entry
2.a Cause of Death Status:
Date Location User Value Reason
Feb-04-2021 09:28:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PRIMARY CAUSE OF DEATHInitial Entry
2.a Cause of Death:
Date Location User Value Reason
Feb-04-2021 09:28:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Cardiac arrestInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0982673
Page 149 of 150
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-07-2021
21:49:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies query
Mar-05-2021
12:38:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Data has been updated.
Mar-02-2021
02:36:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Visit 3 is overdue based
on expected visit window. If
visit 3 will never occur, please
mark Date of Visit as ‘Not
Done’ with form level
comment.
Mar-01-2021
22:21:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Mar-01-2021
16:16:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Subject is deceased
(19-Dec-2020)
Feb-22-2021
20:19:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM Q: Visit
V3_MONTH1_POSTVAX2_L
was expected to occur on
24-DEC-2020. Please enter
data or confirm reason why
visit has not yet occurred.
Else, clarify
Feb-16-2021
13:45:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Jan-22-2021 09:45:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0982674
Page 150 of 150
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1136 Site Name: (1136) Clinical Research Center of Nevada
Subject No: 11361102 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-02-2020
14:21:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOM
IZEDInitial Entry
Nov-02-2020
14:18:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-05-2021 12:49:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/19/2020Changed Information
Mar-05-2021 12:48:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/19/2020Transcription Error
Feb-16-2021 13:45:10
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/22/2021Initial Entry
Jan-22-2021 09:45:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/22/2021Initial Entry
Nov-02-2020 14:21:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/29/2020Initial Entry
Nov-02-2020 14:18:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/29/2020Initial Entry
090177e196ae3f0d\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0982675