Document text
Page 1 of 129
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904434
Page 2 of 129
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/2/2020
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904435
Page 3 of 129
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10371318]
2.Birth Date: 1946
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904436
Page 4 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904437
Page 5 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904438
Page 6 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904439
Page 7 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BILATERAL CATARACTS]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/1990
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HEPATITIS B]
Start Date: UNK/UNK/1968
Ongoing: NO
End Date:
UNK/UNK/2014
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gout]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904440
Page 8 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myocardial Infarct]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chest Pain (unspecified cardiac)]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904441
Page 9 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904442
Page 10 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/2/2020
2.Weight: [99.79]
3.Unit: kg
4.Height: [185.42]
5.Unit: cm
6.Body Mass Index: [29.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904443
Page 11 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/2/2020
2.Randomization Number: [266779]
3.Randomization Group: [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904444
Page 12 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
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 [BK6YKG]
5.bSample ID [BLBB7H]
5.cSample ID [BKP21D]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904445
Page 13 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
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 [BM8SGR]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904446
Page 14 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/2/2020 11:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904447
Page 15 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904448
Page 16 of 129
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/23/2020
2.Erroneous Visit
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904449
Page 17 of 129
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/23/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904450
Page 18 of 129
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/23/2020
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 [BM8SMX]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904451
Page 19 of 129
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/23/2020 09:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904452
Page 20 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/20/2020
2.Erroneous Visit
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904453
Page 21 of 129
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/20/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRJPC8]
5.bSample ID [BS6M65]
5.cSample ID [BRSN3S]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904454
Page 22 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904455
Page 23 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904456
Page 24 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904457
Page 25 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904458
Page 26 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904459
Page 27 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904460
Page 28 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904461
Page 29 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904462
Page 30 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904463
Page 31 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904464
Page 32 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904465
Page 33 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904466
Page 34 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904467
Page 35 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904468
Page 36 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904469
Page 37 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904470
Page 38 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904471
Page 39 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904472
Page 40 of 129
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE E
VENT 1 ELEVATED BLOOD P
RESSURE Dec/15/2020 UN
K:UNK NO
End Date Time:
Dec/18/2020 UNK:UN
K
Repeating
Pages
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904473
Page 41 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[ELEVATED BLOOD PRESSURE]
4.Start Date Time: Dec/15/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/18/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
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
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904474
Page 42 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[PRE-EXISTING MEDICAL]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020508644]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904475
Page 43 of 129
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904476
Page 44 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904477
Page 45 of 129
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904478
Page 46 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904479
Page 47 of 129
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904480
Page 48 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904481
Page 49 of 129
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904482
Page 50 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904483
Page 51 of 129
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904484
Page 52 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904485
Page 53 of 129
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904486
Page 54 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904487
Page 55 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904488
Page 56 of 129
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904489
Page 57 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904490
Page 58 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904491
Page 59 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904492
Page 60 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904493
Page 61 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904494
Page 62 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904495
Page 63 of 129
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904496
Page 64 of 129
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904497
Page 65 of 129
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is NOT willing to return for Vaccination 3 OR otherwise not eligible
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904498
Page 66 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/20/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904499
Page 67 of 129
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904500
Page 68 of 129
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904501
Page 69 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/20/2020
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904502
Page 70 of 129
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904503
Page 71 of 129
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904504
Page 72 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-02-2020 12:01:55 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904505
Page 73 of 129
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
N/A Nov-20-2020 12:29:19 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Lisa Usdan Approved Oct-28-2020 22:23:30 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LisaUsdan, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904506
Page 74 of 129
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-02-2020 11:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-02-2020 11:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904507
Page 75 of 129
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-02-2020 11:59:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Oct/2/2020Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904508
Page 76 of 129
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-02-2020 11:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10371318Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-02-2020 11:56:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1946Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-02-2020 11:59:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-02-2020 11:59:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-02-2020 11:59:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AME
RICANInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904509
Page 77 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-02-2020 11:59:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904510
Page 78 of 129
***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, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-02-2020 12:45:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-02-2020 12:45:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-02-2020 12:45:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904511
Page 79 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Oct-05-2020 10:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:BILATERAL CA
TARACTS
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-05-2020 10:41:27
(UTC-06:00) Central
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
Jan-22-2021 14:44:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-22-2021 13:53:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Jan-22-2021 12:16:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Per SAE report,
subject has a history
of MI, chest pain
and gout. Please
review and confirm
med hx and onset
dates and add to
medical history as
appropriate.
Oct-05-2020 10:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BILATERAL CATARACTSInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904512
Page 80 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.a Start Date:
Date Location User Value Reason
Oct-05-2020 10:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-05-2020 10:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-05-2020 10:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:2
Medical History
Term:HYPERTEN
SION
Start Date: UNK/UNK/1
990
Ongoing: YESTranscription Error
Oct-05-2020 10:43:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:HYPERTENS
ION
Start Date: UNK/UNK/19
90
Ongoing: NO
End Date:
UNK/UNK
/2014Transcription Error
Oct-05-2020 10:41:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:HYPERTENS
IONInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904513
Page 81 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/19
68
Ongoing: NO
End Date:
UNK/UNK
/2014
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904514
Page 82 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Oct-05-2020 10:41:55
(UTC-06:00) Central
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
Jan-22-2021 15:52:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-22-2021 14:05:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Jan-11-2021 19:00:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened CLINICAL Thank
you; however the
request is to add
past med hx of MI
and Chest pain here,
on Med Hx CRF
(currently only
reported to SAE)
Dec-28-2020 15:11:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered UPDATED CRF
PAGE TO BE
UPLOAED TO
FLORENCE
Dec-24-2020 22:49:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical On review
of the SAE report
for Elevated BP,
medical history of
MI and Chest pain
were mentioned, yet
do not appear in the
CRF. Please review
for clinical
relevance to safety
event and update
Med Hx log CRF if
appropriate.
Oct-05-2020 10:41:55 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0904515
Page 83 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)HYPERTENSION
1.b Start Date:
Date Location User Value Reason
Oct-05-2020 10:43:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Transcription Error
Oct-05-2020 10:41:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1968Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-05-2020 10:43:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESTranscription Error
Oct-05-2020 10:41:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.c
Date Location User Value Reason
Oct-05-2020 10:42:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:HEPATITIS B
Start Date: UNK/UNK/196
8
Ongoing: NO
End Date:
UNK/UNK/
2014Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904516
Page 84 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Oct-05-2020 10:42:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-05-2020 10:42:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HEPATITIS BInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-05-2020 10:42:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1968Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-05-2020 10:42:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.d
Date Location User Value Reason
Jan-22-2021 13:45:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History T
erm:Gout
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904517
Page 85 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Jan-22-2021 13:45:44
(UTC-06:00) Central
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
Jan-22-2021 13:45:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GoutInitial Entry
1.d Start Date:
Date Location User Value Reason
Jan-22-2021 13:45:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Jan-22-2021 13:45:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Jan-22-2021 13:47:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Myocardial Infa
rct
Start Date: UNK/UNK/200
9
Ongoing: NO
End Date:
UNK/UNK/
2009Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904518
Page 86 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Jan-22-2021 13:47:22
(UTC-06:00) Central
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
Jan-22-2021 13:47:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Myocardial InfarctInitial Entry
1.e Start Date:
Date Location User Value Reason
Jan-22-2021 13:47:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.e Ongoing:
Date Location User Value Reason
Jan-22-2021 13:47:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.f
Date Location User Value Reason
Feb-09-2021 14:26:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Nu
mber:6
Medical Histo
ry Term:Chest Pain (unspec
ified cardiac)
Start Date: UNK/UNK/2009
Ongoing: YESChanged
Information
Feb-09-2021 14:24:47
(UTC-06:00) CentralACV0PFEINFP6000 Data Entry:
Line/MH Numb 6Changed
Information
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0904519
Page 87 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) er:
Medical Histor
y Term:Chest Pain (unsp
ecified)
Start Date: UNK/UNK/200
9
Ongoing: YES
Jan-22-2021 13:50:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:Chest Pain
Start Date: UNK/UNK/2
009
Ongoing: YESInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0904520
Page 88 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Jan-22-2021 13:50:36
(UTC-06:00) Central
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
Feb-10-2021 10:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Feb-10-2021 10:03:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed New query already
issued by safety.
query is closed to
avoid duplication.
Feb-09-2021 14:26:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Chest Pain (unspecified cardiac)Changed
Information
Feb-09-2021 14:24:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Answered Changed
Information
Feb-09-2021 14:24:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed
Information
Feb-09-2021 14:24:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Chest Pain (unspecified)Changed
Information
Feb-02-2021 12:47:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Opened Clinical Please
clarify this history
as Non-cardiac
Chest pain, or
presumed Cardiac
Chest pain. SAE
report states subject
has been prescribed
nitroglycerin for this
medical condition
Feb-02-2021 12:46:45
(UTC-06:00) CentralACV0PFEINFP6000 Query 3: Closed rewording query
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0904521
Page 89 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
Feb-02-2021 12:42:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical Please
clarify this history
as Non-cardiac
Chest pain, or
presumed Cardiac
Chest pain
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904522
Page 90 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-27-2021 08:32:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened GPDCLIN: Chest
pain is listed as
ongoing since
2009. Please
confirm ongoing
and advise whether
a diagnosis can be
added instead of
symptom. Please
also clarify if
subject met
inclusion criterion
#3 (stable disease
at study entry).
Jan-27-2021 06:43:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Candidate GPDCLIN: Chest
pain is listed as
ongoing since
2009. Please
confirm ongoing
and advise whether
a diagnosis can be
added instead of
symptom. Please
also clarify if
subject met
inclusion criterion
#3 (stable disease
at study entry).
Jan-27-2021 06:42:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed re-open in
candidate state.
Jan-25-2021 08:19:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened GPDCLIN: Chest
pain is listed as
ongoing since
2009. Please
clarify if a
diagnosis can be
added instead of
symptom and if
indeed ongoing,
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904523
Page 91 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
please clarify if
subject met
inclusion criterion
#3.
Jan-22-2021 13:50:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Chest PainInitial Entry
1.f Start Date:
Date Location User Value Reason
Jan-22-2021 13:50:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.f Ongoing:
Date Location User Value Reason
Jan-22-2021 13:50:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904524
Page 92 of 129
***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, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-05-2020 10:43:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904525
Page 93 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-05-2020 10:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-05-2020 10:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
99.79Initial Entry
3. Unit:
Date Location User Value Reason
Oct-05-2020 10:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-05-2020 10:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
185.42Initial Entry
5. Unit:
Date Location User Value Reason
Oct-05-2020 10:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-05-2020 10:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
29.0Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904526
Page 94 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a
Date Location User Value Reason
Oct-05-2020 10:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.4
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-05-2020 10:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-05-2020 10:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.4Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-05-2020 10:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-05-2020 10:44:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904527
Page 95 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-05-2020 10:45:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-05-2020 10:45:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
266779Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904528
Page 96 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 12:45:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 12:45:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020 12:46:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-02-2020 12:45:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-02-2020 12:45:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020 12:46:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BK6YKGInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904529
Page 97 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Oct-02-2020 12:46:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BK6YKGInitial Entry
5.b
Date Location User Value Reason
Oct-02-2020 12:46:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBB7HInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-02-2020 12:46:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLBB7HInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020 12:47:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BKP21DInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-02-2020 12:47:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BKP21DInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904530
Page 98 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 12:47:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 12:47:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020 12:47:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-02-2020 12:47:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-02-2020 12:47:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020 12:47:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8SGRInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904531
Page 99 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Oct-02-2020 12:47:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM8SGRInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904532
Page 100 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-05-2020 10:46:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-05-2020 10:46:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-05-2020 10:46:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-05-2020 10:46:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/2/2020 11:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-05-2020 10:46:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-05-2020 10:46:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904533
Page 101 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Route:
Date Location User Value Reason
Oct-05-2020 10:46:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-05-2020 10:46:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-05-2020 10:46:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904534
Page 102 of 129
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-05-2020 10:46:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904535
Page 103 of 129
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-23-2020 10:40:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904536
Page 104 of 129
***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, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-23-2020 11:21:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020Initial Entry
2.a
Date Location User Value Reason
Oct-23-2020 11:21:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 36.9
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-23-2020 11:21:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-23-2020 11:21:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-23-2020 11:21:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904537
Page 105 of 129
***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, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Temperature Location:
Date Location User Value Reason
Oct-23-2020 11:21:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904538
Page 106 of 129
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-23-2020 10:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-23-2020 10:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-23-2020 10:41:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-23-2020 10:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-23-2020 10:41:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/23/2020Initial Entry
5.a
Date Location User Value Reason
Oct-23-2020 10:41:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BM8SMXInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904539
Page 107 of 129
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Oct-23-2020 10:41:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BM8SMXInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904540
Page 108 of 129
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-23-2020 11:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-23-2020 11:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-23-2020 11:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-23-2020 11:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/23/2020 09:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-23-2020 11:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-23-2020 11:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904541
Page 109 of 129
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Route:
Date Location User Value Reason
Oct-23-2020 11:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-23-2020 11:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-23-2020 11:20:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904542
Page 110 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-23-2020 23:37:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Closed as data
entered.
Nov-23-2020 09:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered DONE
Nov-23-2020 03:48:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The treatment
period is defined as
1st vaccination
visit through the
1-month post
vaccination visit
after the 2nd
vaccination. Please
complete treatment
disposition CRF
and update date of
EOT to match date
of visit at visit 3.
Nov-20-2020 12:29:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/20/2020Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904543
Page 111 of 129
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-20-2020 12:29:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-20-2020 12:29:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-20-2020 12:29:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-20-2020 12:29:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-20-2020 12:29:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/20/2020Initial Entry
5.a
Date Location User Value Reason
Nov-20-2020 12:29:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRJPC8Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904544
Page 112 of 129
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Nov-20-2020 12:29:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRJPC8Initial Entry
5.b
Date Location User Value Reason
Nov-20-2020 12:29:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BS6M65Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-20-2020 12:29:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BS6M65Initial Entry
5.c
Date Location User Value Reason
Nov-20-2020 12:30:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRSN3SInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-20-2020 12:30:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRSN3SInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904545
Page 113 of 129
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904546
Page 114 of 129
***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, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-04-2021 11:00:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Mar-04-2021 11:00:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-04-2021 10:59:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Mar-03-2021 10:32:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-02-2021 15:06:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Answered Medical records not
available and will
not be available as
not medical record
release on file for
this facility. Follow
SAE submitted
Mar-02-2021 15:06:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Medical records not
available and will
not be available as
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904547
Page 115 of 129
***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, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
not medical record
release on file for
this facility. Subject
withdrew consent,
unknown if cardiac
evaluation done.
Mar-02-2021 14:51:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 4: Answered unknown blood
pressure values
Mar-02-2021 14:47:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Records are not
available and never
will be available as
subject withdrew
consent. No medical
record release on
file for hospilization
facility
Mar-01-2021 08:47:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 4: Opened Medical Monitor_
Pls advise blood
pressure values.
Thanks
Feb-23-2021 21:23:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Please follow up and
attempt to obtain
medical records.
Feb-09-2021 14:29:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered No hospital MR
received
Feb-02-2021 12:46:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened Clinical Please
submit a SAE safety
followup specifying
if chest pain during
event 'elevated BP'
was cardiac or
non-cardiac in
origin
Jan-11-2021 19:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical Please
submit a SAE safety
followup with
cardiac evaluation in
hospital for this
event and treatment.
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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) (4)
FDA-CBER-2021-5683-0904548
Page 116 of 129
***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, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-07-2021 14:54:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Please leave query
open until medical
records are received.
Jan-05-2021 11:26:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered subject first reported
due to history of
gout. Then reported
to doctor chest pain.
Will confirm once
medical records are
received.
Jan-04-2021 15:35:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Also noted in source
was hopitalization
for gout. Source also
notes hospitalized
for chest pain.
Please clarify if
subject was
hospitalized for
gout, chest pain or
both. Update source
as appropriate. Are
hospital records
available for
review?
Jan-04-2021 09:26:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ELEVATED BLOOD PRESSUR
EChanged
Information
Jan-04-2021 09:22:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLOOD PRESSURE INCREAS
EDChanged
Information
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ELEVATED BLOOD PRESSUR
EInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/15/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0904549
Page 117 of 129
***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, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Feb-23-2021 21:22:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-19-2021 11:37:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered PD was submitted
Jan-07-2021 14:54:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Please confirm PD
has been reported to
the IRB as SAE was
not reported within
24 hours of site
awareness.
Jan-05-2021 11:28:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Inadvertently
missed
Jan-04-2021 15:36:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Was SAE reported
with 24 hours of site
knowledge? Per
records was not.
Please explain why
event was not
reported within 24
hours of site
awareness of event.
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Dec/18/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904550
Page 118 of 129
***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, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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-04-2021 10:59:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-02-2021 14:55:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Documented on
Follow up report.
Submitted
02MAR2021
Jan-11-2021 19:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical COVID test
status (yes/no)
during Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2020508644] to
document if COVID
testing was
performed (YES/NO
or info not available)
and if yes, the date
and results.
Jan-05-2021 05:38:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-04-2021 09:26:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE ELEVATED
BLOOD
PRESSURE:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-04-2021 09:22:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE BLOOD
PRESSURE
INCREASED:
Response to "Is the
adverse event
serious?" is 'Yes' but
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904551
Page 119 of 129
***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, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
"Serious Adverse
Event Number" is
blank.
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE ELEVATED
BLOOD
PRESSURE:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-04-2021 09:20:59
(UTC-06:00) Central
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?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
NOInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904552
Page 120 of 129
***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, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-05-2021 22:48:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-05-2021 10:49:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Jan-05-2021 10:49:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
PRE-EXISTING MEDIC
ALTranscription Error
Jan-04-2021 23:49:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: The response
for "Is this event
related to study
treatment" Is
reported as 'Not
Related', however
response for, 'Please
indicate what this
event is due to' is
missing. Kindly
review and update.
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATEDInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904553
Page 121 of 129
***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, Not Complete
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-04-2021 09:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-05-2021 05:38:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020508644Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904554
Page 122 of 129
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-23-2020 09:14:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-23-2020 09:14:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-23-2020 09:14:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904555
Page 123 of 129
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-15-2021 07:42:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Feb-15-2021 07:42:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened unfrozen. please
update
Feb-11-2021 10:25:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/20/2021Transcription Error
Feb-10-2021 11:10:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered PLEASE
UNFREEZE BOTH
DATES SO THEY
CAN BE
CHANGED.
Feb-09-2021 12:22:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Per source, date of
visit 20Jan2021.
Please review and
update as
appropriate.
Jan-28-2021 12:43:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904556
Page 124 of 129
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-28-2021 12:44:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to retu
rn for Vaccination 3 OR otherwis
e not eligibleInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904557
Page 125 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-11-2021 10:25:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/20/2021Transcription Error
Jan-28-2021 12:43:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Mar-03-2021
22:17:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Clo
sedResponse satisfies
query
Mar-03-2021
13:05:28
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dCONFIRMED
SUBJECT RECIEVED
PLACEBO. SUBJECT
RTC ON 20 NOV FOR
V3 FU. SUBJ
CONTACTED FOR
ELIG CALL AND
WITHDREW
CONSENT ON 20
JAN.
Mar-02-2021
21:59:00
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dAs Subject is NOT
willing to return for
Vax 3, please confirm
if participant was
assigned to placebo and
returned to safety FUP
or treatment Unblinded
before subject
contacted to confirm
willingness/eligibility
to proceed with Vax 3,
Else, clarify.
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904558
Page 126 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-02-2021
14:53:13
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dSubject moving,
informed site will
receive vaccine outside
of study. Withdrew
consent.
Feb-22-2021
04:14:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7349053;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Jan-28-2021
12:43:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0904559
Page 127 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-23-2020 09:14:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-05-2020 10:45:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-02-2020 12:45:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-11-2021 19:00:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Jan-04-2021 09:48:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered DONE
Dec-31-2020 08:10:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Clinical Thank you.
The event has been
reported by FAX as a
SAE; now please
enter it on the AE
CRF.
Dec-28-2020 15:24:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered EVENT
REPORTED
Dec-27-2020 09:17:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINICAL SAE of
Elevated BP has
been reported
(21020508644);
however, there is no
Event of Elevated
BP reported on the
AE CRF. Please
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (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-2021-5683-0904560
Page 128 of 129
***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: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
update AE CRF.
Nov-23-2020 09:14:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/20/2020Initial Entry
Oct-05-2020 10:45:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/2/2020Initial Entry
Oct-02-2020 12:45:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/2/2020Initial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-0904561
Page 129 of 129
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1037 Site Name: (1037) CNS Healthcare Memphis
Subject No: 10371318 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-28-2020 14:24:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d45\Final\Final On: 01-Apr-2021 04:29 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0904562