Document text
Page 1 of 216
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment
5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917470
Page 2 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/1/2020
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917471
Page 3 of 216
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10571137]
2.Birth Date: 1975
3.Sex: FEMALE
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:
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917472
Page 4 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917473
Page 5 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917474
Page 6 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917475
Page 7 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GOITER]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[THYROIDECTOMY]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MIGRAINE HEADACHES]
Start Date: UNK/UNK/1994
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OBESITY]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917476
Page 8 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MAJOR DEPRESSION]
Start Date: UNK/UNK/2014
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[UTERINE FIBROIDS]
Start Date: UNK/UNK/2000
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS BILATERAL KNEES]
Start Date: UNK/UNK/2010
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BILATERAL TUBAL LIGATION]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917477
Page 9 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PENICILLIN ALLERGY]
Start Date: UNK/UNK/1985
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CESAREAN SECTION] Comments
Start Date: Nov/29/1999
Ongoing: NO
End Date:
Nov/29/1999
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CESAREAN SECTION] Comments
Start Date: May/24/1996
Ongoing: NO
End Date:
May/24/1996
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CESAREAN SECTION] Comments
Start Date: May/20/1994
Ongoing: NO
End Date:
May/20/1994
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917478
Page 10 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPOTHYROIDISM]
Start Date: UNK/UNK/2011
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ASTHMA]
Start Date: UNK/UNK/1980
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[THORACTOMY WITH RESECTION OF BENIGN CARDIAC MASS]
Start Date: Nov/UNK/2008
Ongoing: NO
End Date:
Nov/UNK/2008
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BENIGN CARDIAC MASS]
Start Date: Nov/UNK/2008
Ongoing: NO
End Date:
Nov/UNK/2008
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917479
Page 11 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
2.Weight: [128.4]
3.Unit: kg
4.Height: [175.3]
5.Unit: cm
6.Body Mass Index: [41.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917480
Page 12 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917481
Page 13 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/1/2020
2.Randomization Number: [74980]
3.Randomization Group: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917482
Page 14 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BP1SR2]
5.bSample ID [BP1SR3]
5.cSample ID [BP1SR4]
5.dSample ID [BPJ0SC]
5.eSample ID [BPJ0SD]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917483
Page 15 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BP1GD6]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917484
Page 16 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: Sep/1/2020 11:47
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
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917485
Page 17 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917486
Page 18 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917487
Page 19 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Oct/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917488
Page 20 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917489
Page 21 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BP1SCZ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917490
Page 22 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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/1/2020 13:41
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
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917491
Page 23 of 216
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917492
Page 24 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR0737]
5.bSample ID [BR0738]
5.cSample ID [BR0739]
5.dSample ID [BLBSM5]
5.eSample ID [BLBSM6]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917493
Page 25 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917494
Page 26 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917495
Page 27 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917496
Page 28 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917497
Page 29 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917498
Page 30 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917499
Page 31 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917500
Page 32 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917501
Page 33 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917502
Page 34 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917503
Page 35 of 216
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917504
Page 36 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917505
Page 37 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917506
Page 38 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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 [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917507
Page 39 of 216
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
1.ADVERSE E
VENT 1 WORSENING OF UTERI
NE FIBROIDS Sep/14/2020
08:00 NO
End Date Time:
Sep/19/2020 12:00
Repeating
Pages
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917508
Page 40 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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)[WORSENING OF UTERINE FIBROIDS]
4.Start Date Time: Sep/14/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/19/2020 12:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917509
Page 41 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:
[MEDICAL HISTORY OF UTERINE FIBROIDS]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020369191]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917510
Page 42 of 216
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917511
Page 43 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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[ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917512
Page 44 of 216
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917513
Page 45 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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: //
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917514
Page 46 of 216
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917515
Page 47 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917516
Page 48 of 216
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917517
Page 49 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917518
Page 50 of 216
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917519
Page 51 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917520
Page 52 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917521
Page 53 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917522
Page 54 of 216
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917523
Page 55 of 216
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917524
Page 56 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917525
Page 57 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917526
Page 58 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917527
Page 59 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917528
Page 60 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/25/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917529
Page 61 of 216
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917530
Page 62 of 216
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917531
Page 63 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/4/2021
2.Erroneous Visit
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917532
Page 64 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/4/2021
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917533
Page 65 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917534
Page 66 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Feb/4/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917535
Page 67 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917536
Page 68 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/4/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRF486]
5.bSample ID [BRF487]
5.cSample ID [BRF488]
5.dSample ID [BSB7RW]
5.eSample ID [BSB7RX]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917537
Page 69 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/4/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMYKK]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917538
Page 70 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/4/2021 14:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917539
Page 71 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917540
Page 72 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917541
Page 73 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMYPF]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917542
Page 74 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/25/2021 13:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917543
Page 75 of 216
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917544
Page 76 of 216
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917545
Page 77 of 216
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917546
Page 78 of 216
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917547
Page 79 of 216
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917548
Page 80 of 216
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917549
Page 81 of 216
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917550
Page 82 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/29/2020
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917551
Page 83 of 216
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917552
Page 84 of 216
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Fadi Chalhoub Approved Mar-04-2021 14:16:29 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, FadiChalhoub, 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.
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917553
Page 85 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-01-2020 17:22:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917554
Page 86 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1.jSep-02-2020 11:36:28 (UTC-05:00) Eastern
Time (US & Canada)EXACT DATE NOT CAPTURED AT V1
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917555
Page 87 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1.kSep-02-2020 11:36:46 (UTC-05:00) Eastern
Time (US & Canada)EXACT DATE NOT CAPTURED AT V1
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917556
Page 88 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1.lSep-02-2020 11:37:04 (UTC-05:00) Eastern
Time (US & Canada)EXACT DATE NOT CAPTURED AT V1
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917557
Page 89 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-01-2020 15:04:11 (UTC-05:00) Eastern
Time (US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917558
Page 90 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-01-2020 15:04:11 (UTC-05:00) Eastern
Time (US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917559
Page 91 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Oct-01-2020 15:04:11 (UTC-05:00) Eastern
Time (US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917560
Page 92 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Oct-01-2020 15:04:11 (UTC-05:00) Eastern
Time (US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917561
Page 93 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Oct-01-2020 15:04:11 (UTC-05:00) Eastern
Time (US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917562
Page 94 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Oct-01-2020 15:04:11 (UTC-05:00) Eastern
Time (US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917563
Page 95 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aOct-01-2020 15:04:11 (UTC-05:00) Eastern
Time (US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917564
Page 96 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aOct-01-2020 15:04:11 (UTC-05:00) Eastern
Time (US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917565
Page 97 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aOct-01-2020 15:04:11 (UTC-05:00) Eastern
Time (US & Canada)Not a WOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917566
Page 98 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormFeb-04-2021 15:53:14 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917567
Page 99 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormFeb-04-2021 15:54:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917568
Page 100 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Feb-04-2021 15:54:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917569
Page 101 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Feb-04-2021 15:54:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917570
Page 102 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Feb-04-2021 15:54:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917571
Page 103 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Feb-04-2021 15:54:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917572
Page 104 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Feb-04-2021 15:54:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917573
Page 105 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aFeb-04-2021 15:54:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917574
Page 106 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aFeb-04-2021 15:54:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917575
Page 107 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aFeb-04-2021 15:54:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917576
Page 108 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormFeb-25-2021 14:37:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917577
Page 109 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Feb-25-2021 14:37:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917578
Page 110 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Feb-25-2021 14:37:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917579
Page 111 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Feb-25-2021 14:37:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917580
Page 112 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Feb-25-2021 14:37:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917581
Page 113 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Feb-25-2021 14:37:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917582
Page 114 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aFeb-25-2021 14:37:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917583
Page 115 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aFeb-25-2021 14:37:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917584
Page 116 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aFeb-25-2021 14:37:23 (UTC-05:00) Eastern
Time (US & Canada)NOT FOCBP
Not Applicable
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917585
Page 117 of 216
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Fadi Chalhoub Approved Mar-04-2021 14:16:29 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, FadiChalhoub, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-04-2021 15:51:54 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi Chalhoub Approved Nov-03-2020 19:57:12 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, FadiChalhoub, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Nov-03-2020 09:25:28 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917586
Page 118 of 216
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Fadi Chalhoub Approved Oct-30-2020 18:16:05 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, FadiChalhoub, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-30-2020 12:53:30 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi Chalhoub Approved Oct-29-2020 20:02:15 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, FadiChalhoub, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Oct-29-2020 15:55:16 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi Chalhoub Approved Oct-26-2020 19:06:00 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917587
Page 119 of 216
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Affidavit:
By my dated signature below, I, FadiChalhoub, 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.
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917588
Page 120 of 216
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-01-2020 17:21:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-01-2020 17:21:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917589
Page 121 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-01-2020 17:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Sep/1/2020Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917590
Page 122 of 216
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-01-2020 17:21:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10571137Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-01-2020 17:20:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1975Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-01-2020 17:21:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-01-2020 17:21:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-01-2020 17:21:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLACK OR AFRICAN AME
RICANInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917591
Page 123 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020 17:22:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917592
Page 124 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-01-2020 17:22:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-01-2020 17:22:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-01-2020 17:22:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917593
Page 125 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Sep-01-2020 17:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical Histor
y Term:GOITER
Start Date: UNK/UNK/20
11
Ongoing: NO
End Date:
UNK/UNK
/2011Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-01-2020 17:26:36
(UTC-05:00) Eastern
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
Sep-01-2020 17:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GOITERInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-01-2020 17:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.a Ongoing:
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917594
Page 126 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-01-2020 17:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.b
Date Location User Value Reason
Sep-01-2020 17:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:THYROIDEC
TOMY
Start Date: UNK/UNK/20
11
Ongoing: NO
End Date:
UNK/UNK/
2011Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917595
Page 127 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b Line/MH Number:
Date Location User Value Reason
Sep-01-2020 17:26:50
(UTC-05:00) Eastern
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
Sep-01-2020 17:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
THYROIDECTOMYInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-01-2020 17:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-01-2020 17:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.c
Date Location User Value Reason
Sep-01-2020 17:27:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:MIGRAINE HE
ADACHES
Start Date: UNK/UNK/199
4Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917596
Page 128 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-01-2020 17:27:02
(UTC-05:00) Eastern
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
Sep-01-2020 17:27:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MIGRAINE HEADACHESInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-01-2020 17:27:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1994Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-01-2020 17:27:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-01-2020 17:27:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:OBESITY
Start Date: UNK/UNK/
2000Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917597
Page 129 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-01-2020 17:27:11
(UTC-05:00) Eastern
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
Sep-01-2020 17:27:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBESITYInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-01-2020 17:27:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-01-2020 17:27:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-01-2020 17:27:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:MAJOR DEPR
ESSION
Start Date: UNK/UNK/201
4Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917598
Page 130 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-01-2020 17:27:23
(UTC-05:00) Eastern
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
Sep-01-2020 17:27:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MAJOR DEPRESSIONInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-01-2020 17:27:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-01-2020 17:27:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-01-2020 17:27:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:UTERINE FIB
ROIDS
Start Date: UNK/UNK/20
00Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917599
Page 131 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Sep-01-2020 17:27:37
(UTC-05:00) Eastern
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
Sep-01-2020 17:27:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UTERINE FIBROIDSInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-01-2020 17:27:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-01-2020 17:27:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-01-2020 17:27:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical Hi
story Term
:OSTEOARTHRITI
S BILATERAL KN
EES
Start Date: UNK/UNK/2010Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917600
Page 132 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Sep-01-2020 17:27:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 17:27:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OSTEOARTHRITIS BILATE
RAL KNEESInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-01-2020 17:27:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-01-2020 17:27:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-02-2020 13:32:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH
Number:8
Medical H
istory Ter
m:BILATERAL T
UBAL LIGATI
ONNew Information
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917601
Page 133 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Start Date
:UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1
999
Sep-01-2020 17:28:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:TUBAL LIG
ATION
Start Date: UNK/UNK/1
999
Ongoing: NO
End Date:
UNK/UN
K/1999Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917602
Page 134 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.h Line/MH Number:
Date Location User Value Reason
Sep-01-2020 17:28:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-02-2020 15:36:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Oct-02-2020 13:32:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-02-2020 13:32:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BILATERAL TUBAL LIG
ATIONNew Information
Oct-02-2020 10:28:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY:
Please clarify in
event term if
bilateral/unilateral
Sep-01-2020 17:28:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TUBAL LIGATIONInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-01-2020 17:28:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1999Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-01-2020 17:28:10
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917603
Page 135 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) End Date:
UNK/UNK/1999
1.i
Date Location User Value Reason
Sep-01-2020 17:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histo
ry Term:PENICILLIN A
LLERGY
Start Date: UNK/UNK/198
5
Ongoing: YESInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917604
Page 136 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.i Line/MH Number:
Date Location User Value Reason
Sep-01-2020 17:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020 17:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PENICILLIN ALLERGYInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-01-2020 17:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-01-2020 17:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917605
Page 137 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.j
Date Location User Value Reason
Oct-06-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:10
Medical His
tory Term:CESAREAN
SECTION
Start Date: Nov/29/1999
Ongoing: NO
End Date:
Nov/29/19
99Changed
Information
Oct-02-2020 08:42:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:10
Medical His
tory Term:CESAREAN
SECTION
Start Date: UNK/UNK/19
99
Ongoing: NO
End Date:
Nov/29/19
99New Information
Sep-02-2020 11:35:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:10
Medical His
tory Term:CESAREAN
SECTION
Start Date: UNK/UNK/19
99
Ongoing: NO
End Date:
UNK/UNK
/1999Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917606
Page 138 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.j Line/MH Number:
Date Location User Value Reason
Sep-02-2020 11:35:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 11:35:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CESAREAN SECTIONInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-06-2020 12:41:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Oct-06-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Oct-06-2020 11:57:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/29/1999Changed
Information
Oct-05-2020 14:41:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
End date of
procedure has been
amended but now
is not matching to
start date. It is
expected that
procedures would
have the same start
and end dates.
Please review and
update as
appropriate.
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917607
Page 139 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-05-2020 09:28:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Candidate CLINQUERY:
End date of
procedure has been
amended but now
is not matching to
start date. It is
expected that
procedures would
have the same start
and end dates.
Please review and
update as
appropriate.
Sep-02-2020 11:35:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1999Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-02-2020 08:42:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/29/1999New Information
Sep-02-2020 11:35:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1999Initial Entry
1.k
Date Location User Value Reason
Oct-06-2020 11:58:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:11
Medical His
tory Term:CESAREAN
SECTION
Start Date: May/24/1996Changed
Information
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917608
Page 140 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: NO
End Date:
May/24/19
96
Oct-02-2020 08:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:11
Medical His
tory Term:CESAREAN
SECTION
Start Date: UNK/UNK/19
96
Ongoing: NO
End Date:
May/24/19
96New Information
Sep-02-2020 11:35:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:11
Medical His
tory Term:CESAREAN
SECTION
Start Date: UNK/UNK/19
96
Ongoing: NO
End Date:
UNK/UNK
/1996Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917609
Page 141 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.k Line/MH Number:
Date Location User Value Reason
Sep-02-2020 11:35:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 11:35:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CESAREAN SECTIONInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-06-2020 12:41:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Oct-06-2020 11:58:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Oct-06-2020 11:58:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/24/1996Changed
Information
Oct-05-2020 14:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
End date of
procedure has been
amended but now
is not matching to
start date. It is
expected that
procedures would
have the same start
and end dates.
Please review and
update as
appropriate.
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917610
Page 142 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-05-2020 09:29:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Candidate CLINQUERY:
End date of
procedure has been
amended but now
is not matching to
start date. It is
expected that
procedures would
have the same start
and end dates.
Please review and
update as
appropriate.
Sep-02-2020 11:35:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1996Initial Entry
1.k Ongoing:
Date Location User Value Reason
Oct-02-2020 08:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
May/24/1996New Information
Sep-02-2020 11:35:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1996Initial Entry
1.l
Date Location User Value Reason
Oct-06-2020 11:58:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:12
Medical His
tory Term:CESAREAN
SECTION
Start Date: May/20/1994Changed
Information
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917611
Page 143 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: NO
End Date:
May/20/19
94
Oct-02-2020 08:42:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:12
Medical His
tory Term:CESAREAN
SECTION
Start Date: UNK/UNK/19
94
Ongoing: NO
End Date:
May/20/19
94New Information
Sep-02-2020 11:35:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:12
Medical His
tory Term:CESAREAN
SECTION
Start Date: UNK/UNK/19
94
Ongoing: NO
End Date:
UNK/UNK
/1994Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917612
Page 144 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.l Line/MH Number:
Date Location User Value Reason
Sep-02-2020 11:35:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-02-2020 11:35:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CESAREAN SECTIONInitial Entry
1.l Start Date:
Date Location User Value Reason
Oct-06-2020 12:41:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Oct-06-2020 11:58:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Oct-06-2020 11:58:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
May/20/1994Changed
Information
Oct-05-2020 14:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened CLINQUERY:
End date of
procedure has been
amended but now
is not matching to
start date. It is
expected that
procedures would
have the same start
and end dates.
Please review and
update as
appropriate.
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917613
Page 145 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-05-2020 09:29:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Candidate CLINQUERY:
End date of
procedure has been
amended but now
is not matching to
start date. It is
expected that
procedures would
have the same start
and end dates.
Please review and
update as
appropriate.
Sep-02-2020 11:35:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1994Initial Entry
1.l Ongoing:
Date Location User Value Reason
Oct-02-2020 08:42:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
May/20/1994New Information
Sep-02-2020 11:35:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1994Initial Entry
1.m
Date Location User Value Reason
Oct-07-2020 16:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:13
Medical Histor
y Term:HYPOTHYR
OIDISM
Start Date: UNK/UNK/20
11Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917614
Page 146 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: YES
1.m Line/MH Number:
Date Location User Value Reason
Oct-07-2020 16:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 16:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HYPOTHYROIDISMInitial Entry
1.m Start Date:
Date Location User Value Reason
Oct-07-2020 16:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2011Initial Entry
1.m Ongoing:
Date Location User Value Reason
Oct-07-2020 16:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Oct-07-2020 16:25:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:14
Medical History
Term:ASTHMA
Start Date: UNK/UNK/
1980Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917615
Page 147 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: YES
1.n Line/MH Number:
Date Location User Value Reason
Oct-07-2020 16:25:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 16:25:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASTHMAInitial Entry
1.n Start Date:
Date Location User Value Reason
Oct-07-2020 16:25:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.n Ongoing:
Date Location User Value Reason
Oct-07-2020 16:25:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Oct-07-2020 16:26:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:15Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917616
Page 148 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Medica
l Histor
y Term:THORACTOMY WIT
H RESECTION OF B
ENIGN CARDIAC M
ASS
Start D
ate:Nov/UNK/2008
Ongoin
g:NO
End Date:
Nov/UNK/2008
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917617
Page 149 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.o Line/MH Number:
Date Location User Value Reason
Oct-07-2020 16:26:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 16:26:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
THORACTOMY WITH RES
ECTION OF BENIGN CAR
DIAC MASSInitial Entry
1.o Start Date:
Date Location User Value Reason
Oct-07-2020 16:26:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/UNK/2008Initial Entry
1.o Ongoing:
Date Location User Value Reason
Oct-07-2020 16:26:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/UNK/2008Initial Entry
1.p
Date Location User Value Reason
Oct-07-2020 16:29:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:16
Medical Hist
ory Term:BENIGN CARDI
AC MASSInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917618
Page 150 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Start Date: Nov/UNK/2008
Ongoing: NO
End Date:
Nov/UNK/200
8
1.p Line/MH Number:
Date Location User Value Reason
Oct-07-2020 16:29:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 16:29:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BENIGN CARDIAC MASSInitial Entry
1.p Start Date:
Date Location User Value Reason
Oct-07-2020 16:29:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Nov/UNK/2008Initial Entry
1.p Ongoing:
Date Location User Value Reason
Oct-07-2020 16:29:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Nov/UNK/2008Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917619
Page 151 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 17:23:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-01-2020 17:23:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
128.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-01-2020 17:23:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-01-2020 17:23:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
175.3Initial Entry
5. Unit:
Date Location User Value Reason
Sep-01-2020 17:23:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0917620
Page 152 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-01-2020 17:23:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
41.8Initial Entry
7.a
Date Location User Value Reason
Sep-01-2020 17:23:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 36.1
Temperature U
nit:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 17:23:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-01-2020 17:23:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-01-2020 17:23:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917621
Page 153 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-01-2020 17:23:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917622
Page 154 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-01-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-01-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-01-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917623
Page 155 of 216
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-01-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-01-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-01-2020 17:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917624
Page 156 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-01-2020 17:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-01-2020 17:28:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
74980Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917625
Page 157 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 08:46:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 08:46:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 08:46:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 08:46:03
(UTC-05:00) Eastern
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.
Sep-02-2020 08:46:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917626
Page 158 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-02-2020 08:46:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1SR2Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 08:46:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1SR2Initial Entry
5.b
Date Location User Value Reason
Sep-02-2020 08:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1SR3Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-02-2020 08:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1SR3Initial Entry
5.c
Date Location User Value Reason
Sep-02-2020 08:46:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1SR4Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-02-2020 08:46:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1SR4Initial Entry
5.d
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0917627
Page 159 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-02-2020 08:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPJ0SCInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-02-2020 08:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPJ0SCInitial Entry
5.e
Date Location User Value Reason
Sep-02-2020 08:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPJ0SDInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-02-2020 08:46:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPJ0SDInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917628
Page 160 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 09:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 09:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 09:04:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 09:03:50
(UTC-05:00) Eastern
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.
Sep-02-2020 09:03:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917629
Page 161 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-02-2020 09:04:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1GD6Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 09:04:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1GD6Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917630
Page 162 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020 17:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 17:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 17:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-01-2020 17:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 11:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 17:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917631
Page 163 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-01-2020 17:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020 17:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020 17:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-01-2020 17:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917632
Page 164 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-01-2020 17:28:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917633
Page 165 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 06:43:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Closed per SITE
response, added to
PD tracker
Oct-06-2020 16:24:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered DATA IS
CORRECT AS
ENTERED. NO
TEMPORARY
DELAY OF
VACCINATION.
Oct-06-2020 10:33:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened PDQ: DOV at this
visit is out of
window (2 day)
from DOV (10/Sep
/2020) at
V1D1VX1L. Please
either update DOV
or confirm whether
visit is out of
window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Oct-01-2020 14:58:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Initial Entry
Oct-01-2020 14:58:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
Oct-01-2020 03:05:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Candidat
eAs per the query
response, keeping
this query in
candidate , please
update when data is
available. Thank
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0917634
Page 166 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
you
Sep-30-2020 14:46:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Site is contractually
obligated to resolve
queries within 24
hours. Site will not
violate study
contract. Data will
be entered when
collected.
Re-issuing of this
query is
unnecessary and
will result in
immediate closing
by the site with the
same response
Sep-30-2020 12:27:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened Please respond to
this query once
action has been
taken.
Sep-29-2020 15:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered site is responsible
for closing queries
within a certain
timeframe. cannot
leave open until
visit occurs.
Sep-26-2020 06:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sandip
Namdeorao
SuryawanshiQuery 1: Reissued:Opened Kindly keep query
in open status until
visit is occurred.
Thank you.
Sep-25-2020 11:35:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered visit not done yet
Sep-25-2020 02:35:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: Kindly review
and complete ‘Date
of Visit, Nasal
Swab, Pregnancy
Test, Vaccination,
Vital Signs' forms at
this visit. Thank
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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)
FDA-CBER-2021-5683-0917635
Page 167 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
you.
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917636
Page 168 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Oct-01-2020 14:59:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
2.a
Date Location User Value Reason
Oct-01-2020 14:59:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier
::1
Temperature: 36.0
Temperature Uni
t:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-01-2020 14:59:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-02-2020 01:05:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Oct-01-2020 15:04:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Original value is
correct
Oct-01-2020 14:59:06
(UTC-05:00) EasternACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 36 C
is outside of
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0917637
Page 169 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) Normal Range
36.1 - 37.5 C.
Oct-01-2020 14:59:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
36.0Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-01-2020 14:59:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-01-2020 14:59:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917638
Page 170 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-01-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-01-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-23-2020 18:54:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Closed Response satisfies
query
Oct-22-2020 12:05:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered PATIENT HAD A
HYSTERECTOMY
BETWEEN V1
AND V2 AS A
CORRECTIVE
ACTION FOR THE
SAE OF
WORSENING OF
UTERINE
FIBROIDS
Oct-22-2020 06:37:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper Query 1: Opened CLINQUERY:
Please review and
clarify why no
pregnancy test was
performed at V2.
(Test completed at
V1).
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917639
Page 171 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-01-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-01-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-01-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-01-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-01-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0917640
Page 172 of 216
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-01-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-01-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-01-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917641
Page 173 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 18:23:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 18:23:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 18:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 18:23:31
(UTC-05:00) Eastern
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-01-2020 18:23:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917642
Page 174 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-01-2020 18:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP1SCZInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020 18:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP1SCZInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917643
Page 175 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-01-2020 14:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020 14:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-01-2020 14:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-01-2020 14:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020 13:41Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020 14:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917644
Page 176 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-01-2020 14:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-01-2020 14:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-01-2020 14:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-01-2020 14:59:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917645
Page 177 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020 15:08:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Nov-03-2020 09:33:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Nov-03-2020 05:51:44
(UTC-05:00) Eastern
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.
Oct-29-2020 15:55:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917646
Page 178 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 12:53:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 12:53:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 12:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 12:53:30
(UTC-05:00) Eastern
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-30-2020 12:53:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917647
Page 179 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-30-2020 12:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR0737Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020 12:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR0737Initial Entry
5.b
Date Location User Value Reason
Oct-30-2020 12:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR0738Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-30-2020 12:53:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR0738Initial Entry
5.c
Date Location User Value Reason
Oct-30-2020 12:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BR0739Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-30-2020 12:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BR0739Initial Entry
5.d
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0917648
Page 180 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-30-2020 12:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBSM5Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-30-2020 12:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLBSM5Initial Entry
5.e
Date Location User Value Reason
Oct-30-2020 12:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLBSM6Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-30-2020 12:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLBSM6Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917649
Page 181 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-03-2020 09:25:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-03-2020 09:25:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-03-2020 09:25:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917650
Page 182 of 216
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917651
Page 183 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
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
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WORSENING OF UTERINE
FIBROIDSInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/14/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/19/2020 12:00Initial Entry
6. Toxicity Grade:
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917652
Page 184 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-04-2020 12:39:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Nov-03-2020 12:31:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered medical records
received do not
show COVID test,
site has
re-requested
records specifically
asking for COVID
test results. Site
will update SAE
once records from
COVID test are
received or
confirmation that
no test was done is
received.
Oct-30-2020 22:09:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Clinical Previous
SAE reports did not
report any COVID
test; this is the
current knowledge
about COVID test
during
Hospitalization.
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917653
Page 185 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Please report this
information (no
COVID test in
Hosp) as SAE f/u;
additional info can
be submitted if
received later
Oct-29-2020 15:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered SAE follow up
reports are
submitted when
new or changed
information is
available. Absence
of events are not
captured in follow
up reports. Previous
SAE reports do not
state subject had a
COVID test. This
has not changed.
Oct-29-2020 00:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Clinical - Thank
you. Reviewed
SAE report; no
COVID test is
mentioned. Was it
conducted? or was
no COVID test
performed in Hosp
- please submit
either scenario as a
SAE followup
Oct-28-2020 13:16:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Per SC f/u SAE
form is only
completed if there
is new information
to report. Initial
report did mention
a COVID test being
conducted.
Oct-28-2020 00:10:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened Clinical – Thank
you. If NO hospital
Covid test was
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917654
Page 186 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
performed is
known, please
submit this
information on a
follow-up SAE
form, as pertinent
information for this
trial.
Oct-27-2020 17:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered there was not any
indication per
medical records in
source that a
COVID test was
performed.
Oct-23-2020 20:54:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE
form
[#2020369191] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Sep-24-2020 05:26:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-24-2020 01:28:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened For AE
WORSENING OF
UTERINE
FIBROIDS:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917655
Page 187 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
WORSENING OF
UTERINE
FIBROIDS:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resul
t in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
YES
Did this serious event resul
t in persistent or significant
disability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
NOInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917656
Page 188 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-27-2020
01:56:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
ClosedResponse
satisfies query
Sep-25-2020
11:33:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Answere
ddata is correct
as is
Sep-25-2020
06:21:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1:
Reissue
d:Opene
dDM: Please
review "If not
related to
study
treatment
other" field,
the following
text was
indicated in
the comment
field [medical
history]. Any
symptoms,
AEs or other
key data
should be
collected on
the
appropriate
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917657
Page 189 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
page. Else
clarify in
query
response.
Sep-24-2020
15:31:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answere
dNew
Information
Sep-24-2020
15:31:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
NOT R
ELATE
D
If Not
Relate
d to st
udy tre
atment
(s), thi
s event
is due t
o:
OTH
ER
If O
ther
, sp
ecif
y:
M
E
DI
C
A
L
HI
S
TNew
Information
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917658
Page 190 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
O
R
Y
O
F
U
T
E
RI
N
E
FI
B
R
OI
D
S
Sep-24-2020
14:51:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1:
OpenedPlease review
"If not related
to study
treatment
other" field,
the following
text was
indicated in
the comment
field [medical
history]. Any
symptoms,
AEs or other
key data
should be
collected on
the
appropriate
page. If this is
already in the
predefined list
above please
choose the
appropriate
value. Please
review and
update as
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917659
Page 191 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
necessary.
Sep-23-2020
16:41:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data En
try:
NOT R
ELATE
D
If Not
Relate
d to st
udy tre
atment
(s), thi
s event
is due t
o:
OTH
ER
If O
ther
, sp
ecif
y:
M
E
DI
C
A
L
HI
S
T
O
R
YInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917660
Page 192 of 216
***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, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
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
Sep-23-2020 16:41:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-24-2020 05:26:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2020369191Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0917661
Page 193 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 15:51:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917662
Page 194 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-04-2021 15:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-04-2021 15:52:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-04-2021 15:52:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to retur
n for Vaccination 3
Participant is:
eligible per local/national
recommendations and co
nfirmed to have received
only placebo at Vaccinati
on 1/2Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917663
Page 195 of 216
***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: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-04-2021 15:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/25/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-04-2021 15:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917664
Page 196 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-04-2021 15:52:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917665
Page 197 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-04-2021 15:53:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Feb/4/2021Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917666
Page 198 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-04-2021 15:53:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-04-2021 15:53:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-04-2021 15:53:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917667
Page 199 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-04-2021 15:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-04-2021 15:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-04-2021 15:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-04-2021 15:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-04-2021 15:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0917668
Page 200 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-04-2021 15:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined
Identifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-04-2021 15:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Feb-04-2021 15:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Feb-04-2021 15:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Feb-04-2021 15:54:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0917669
Page 201 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-05-2021 13:24:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-05-2021 13:24:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-05-2021 13:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-05-2021 13:24:01
(UTC-05:00) Eastern
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.
Feb-05-2021 13:24:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/4/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917670
Page 202 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-05-2021 13:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRF486Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-05-2021 13:24:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRF486Initial Entry
5.b
Date Location User Value Reason
Feb-05-2021 13:24:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRF487Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-05-2021 13:24:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRF487Initial Entry
5.c
Date Location User Value Reason
Feb-05-2021 13:24:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRF488Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-05-2021 13:24:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRF488Initial Entry
5.d
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0917671
Page 203 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Feb-05-2021 13:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSB7RWInitial Entry
5.d Sample ID
Date Location User Value Reason
Feb-05-2021 13:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSB7RWInitial Entry
5.e
Date Location User Value Reason
Feb-05-2021 13:24:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSB7RXInitial Entry
5.e Sample ID
Date Location User Value Reason
Feb-05-2021 13:24:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSB7RXInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917672
Page 204 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-05-2021 13:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-05-2021 13:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-05-2021 13:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-05-2021 13:23:44
(UTC-05:00) Eastern
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.
Feb-05-2021 13:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/4/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917673
Page 205 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-05-2021 13:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRMYKKInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-05-2021 13:23:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRMYKKInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917674
Page 206 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-04-2021 15:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-04-2021 15:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-04-2021 15:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-04-2021 15:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/4/2021 14:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-04-2021 15:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917675
Page 207 of 216
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-04-2021 15:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-04-2021 15:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-04-2021 15:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-04-2021 15:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-04-2021 15:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-04-2021 15:53:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917676
Page 208 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021 14:36:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/25/2021Initial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917677
Page 209 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-25-2021 14:37:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-25-2021 14:37:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-25-2021 14:37:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-25-2021 14:37:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-25-2021 14:37:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0917678
Page 210 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-25-2021 14:37:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defined
Identifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-25-2021 14:37:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Feb-25-2021 14:37:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Feb-25-2021 14:37:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Feb-25-2021 14:37:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (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-2021-5683-0917679
Page 211 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 10:59:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 10:59:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 10:59:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 10:59:23
(UTC-05:00) Eastern
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.
Feb-26-2021 10:59:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917680
Page 212 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-26-2021 10:59:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRMYPFInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 10:59:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BRMYPFInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917681
Page 213 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-25-2021 14:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-25-2021 14:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-25-2021 14:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-25-2021 14:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/25/2021 13:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-25-2021 14:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917682
Page 214 of 216
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571137 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Feb-25-2021 14:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-25-2021 14:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-25-2021 14:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-25-2021 14:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-25-2021 14:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-25-2021 14:36:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e22\Final\Final On: 01-Apr-2021 04:46 (GMT)
(b) (4),
(b) (6)
(b) (4),
…[truncated]