125742 S1 M5 CRF c4591001 1057 10571188

Document text

Page 1 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917686
Page 2 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/14/2020
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917687
Page 3 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Demography
1.Subject ID [10571188]
2.Birth Date: /1968
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917688
Page 4 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917689
Page 5 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917690
Page 6 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917691
Page 7 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Oxycodone Allergy]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Gastric Bypass]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Postmenopausal]
Start Date: Jan/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Hypothyroidism]
Start Date: UNK/UNK/2018
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Menorrhagia]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917692
Page 8 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Uterine ablation]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917693
Page 9 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
2.Weight: [75.2]
3.Unit: kg
4.Height: [168.5]
5.Unit: cm
6.Body Mass Index: [26.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917694
Page 10 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/14/2020
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:
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917695
Page 11 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/14/2020
2.Randomization Number: [89518]
3.Randomization Group: [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917696
Page 12 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
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 [BP1SX5]
5.bSample ID [BP1SX6]
5.cSample ID [BP1SX7]
5.dSample ID [BPJ0WS]
5.eSample ID [BPJ0WT]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917697
Page 13 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
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 [BP1GJ6]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917698
Page 14 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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/14/2020 14:28
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917699
Page 15 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917700
Page 16 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917701
Page 17 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Vital Signs
1.Date: Oct/7/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917702
Page 18 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/7/2020
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:
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917703
Page 19 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
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 [BP1SF3]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917704
Page 20 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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/7/2020 13:58
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
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917705
Page 21 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917706
Page 22 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/12/2020
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 [BR0KT5]
5.bSample ID [BR0KT6]
5.cSample ID [BR0KT7]
5.dSample ID [BLBSSM]
5.eSample ID [BLBSSN]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917707
Page 23 of 145
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917708
Page 24 of 145
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917709
Page 25 of 145
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917710
Page 26 of 145
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917711
Page 27 of 145
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917712
Page 28 of 145
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917713
Page 29 of 145
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917714
Page 30 of 145
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917715
Page 31 of 145
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917716
Page 32 of 145
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917717
Page 33 of 145
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: 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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917718
Page 34 of 145
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917719
Page 35 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917720
Page 36 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917721
Page 37 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917722
Page 38 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Unplanned Assessments
1.Assessments
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917723
Page 39 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917724
Page 40 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917725
Page 41 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917726
Page 42 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917727
Page 43 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EVE
NT 1  DIZZINESS  Oct/7/2020 21:0
0 YES  Repeating
Pages
 2.ADVERSE EVE
NT 2  HEARING LOSS IN RIGH
T EAR Oct/8/2020 08:0
0 YES  Repeating
Pages
 3.ADVERSE EVE
NT 3  FALL  Nov/24/2020 18
:00 NO
End Date Time:
Nov/24/2020 18:00
 Repeating
Pages
 4.ADVERSE EVE
NT 4  BROKEN RIGHT ARM  Nov/24/2020 18
:00 YES  Repeating
Pages
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917728
Page 44 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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)[DIZZINESS]
4.Start Date Time: Oct/7/2020 21:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917729
Page 45 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917730
Page 46 of 145
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[HEARING LOSS IN RIGHT EAR]
4.Start Date Time: Oct/8/2020 08:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917731
Page 47 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917732
Page 48 of 145
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[FALL]
4.Start Date Time: Nov/24/2020 18:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/24/2020 18:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917733
Page 49 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917734
Page 50 of 145
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[BROKEN RIGHT ARM]
4.Start Date Time: Nov/24/2020 18:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917735
Page 51 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917736
Page 52 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917737
Page 53 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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[ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917738
Page 54 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917739
Page 55 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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: //
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917740
Page 56 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917741
Page 57 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917742
Page 58 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917743
Page 59 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917744
Page 60 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917745
Page 61 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917746
Page 62 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917747
Page 63 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917748
Page 64 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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:
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917749
Page 65 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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?
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917750
Page 66 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917751
Page 67 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917752
Page 68 of 145
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - 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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917753
Page 69 of 145
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917754
Page 70 of 145
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917755
Page 71 of 145
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: 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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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 [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917756
Page 72 of 145
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917757
Page 73 of 145
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917758
Page 74 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/15/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917759
Page 75 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917760
Page 76 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917761
Page 77 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/12/2020
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917762
Page 78 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917763
Page 79 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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-05-2021 09:06:30 (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.
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917764
Page 80 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
ItemDate User Comment
FormSep-14-2020 15:25:28 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0917765
Page 81 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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-05-2021 09:06:30 (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-08-2021 13:54:53 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi Chalhoub  Approved Jan-24-2021 13:20:35 (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 Dec-18-2020 12:58:18 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi Chalhoub  Approved Nov-13-2020 13:54:52 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917766
Page 82 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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-12-2020 16:13:00 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Fadi Chalhoub  Approved Nov-06-2020 13:51:21 (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.
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917767
Page 83 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-14-2020 15:24:30
(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-14-2020 15:24:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917768
Page 84 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-14-2020 15:24:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/14/2020Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917769
Page 85 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-14-2020 15:24:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10571188Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-14-2020 15:24:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1968Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-14-2020 15:24:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-14-2020 15:24:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-14-2020 15:24:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917770
Page 86 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-14-2020 15:25:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917771
Page 87 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-14-2020 15:25:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-14-2020 15:25:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-14-2020 15:25:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917772
Page 88 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1.a
Date Location User Value Reason
Sep-14-2020 15:30:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:Oxycodone Alle
rgy
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-14-2020 15:30:12
(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-14-2020 15:30:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oxycodone AllergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-14-2020 15:30:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-14-2020 15:30:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-14-2020 15:30:30
(UTC-05:00) Eastern TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917773
Page 89 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada) Line/MH Number: 2
Medical History Te
rm:Gastric Bypass
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2
018
1.b Line/MH Number:
Date Location User Value Reason
Sep-14-2020 15:30:30
(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-14-2020 15:30:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Gastric BypassInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-14-2020 15:30:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-14-2020 15:30:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.c
Date Location User Value Reason
Sep-14-2020 15:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917774
Page 90 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Medical History Ter
m:Postmenopaus
al
Start Date: Jan/UNK/2019
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-14-2020 15:30:48
(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-14-2020 15:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PostmenopausalInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-14-2020 15:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-14-2020 15:30:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-14-2020 15:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:Hypothyroidis
m
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917775
Page 91 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.d Line/MH Number:
Date Location User Value Reason
Sep-14-2020 15:31:01
(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-14-2020 15:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypothyroidismInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-14-2020 15:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-14-2020 15:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-14-2020 15:31:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:Menorrhagia
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2
008Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917776
Page 92 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.e Line/MH Number:
Date Location User Value Reason
Sep-14-2020 15:31:25
(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-14-2020 15:31:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MenorrhagiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-14-2020 15:31:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-14-2020 15:31:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
1.f
Date Location User Value Reason
Sep-14-2020 15:33:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:Uterine ablation
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2
008Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917777
Page 93 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
1.f Line/MH Number:
Date Location User Value Reason
Sep-14-2020 15:33:44
(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-14-2020 15:33:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Uterine ablationInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-14-2020 15:33:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-14-2020 15:33:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917778
Page 94 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Sep-14-2020 15:27:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-14-2020 15:27:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
75.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-14-2020 15:27:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-14-2020 15:27:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
168.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-14-2020 15:27:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-14-2020 15:27:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.5Initial Entry
7.a
Date Location User Value Reason
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (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-2021-5683-0917779
Page 95 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Sep-14-2020 15:27:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.9
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-14-2020 15:27:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-14-2020 15:27:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
36.9Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-14-2020 15:27:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-14-2020 15:27:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (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-2021-5683-0917780
Page 96 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-14-2020 15:27:26
(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-14-2020 15:27:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-14-2020 15:27:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-14-2020 15:27:26
(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-14-2020 15:27:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-14-2020 15:27:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917781
Page 97 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-14-2020 15:27:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-14-2020 15:27:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-14-2020 15:27:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917782
Page 98 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-14-2020 15:26:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-14-2020 15:26:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
89518Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917783
Page 99 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 08:16:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 08:16:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-15-2020 08:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 08:16:49
(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-15-2020 08:16:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020 08:17:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1SX5Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-15-2020 08:17:13
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
BP1SX5Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0917784
Page 100 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada)
5.b
Date Location User Value Reason
Sep-15-2020 08:17:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1SX6Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-15-2020 08:17:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP1SX6Initial Entry
5.c
Date Location User Value Reason
Sep-15-2020 08:17:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1SX7Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-15-2020 08:17:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP1SX7Initial Entry
5.d
Date Location User Value Reason
Sep-15-2020 08:17:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPJ0WSInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-15-2020 08:17:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPJ0WSInitial Entry
5.e
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917785
Page 101 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Sep-15-2020 08:17:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPJ0WTInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-15-2020 08:17:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPJ0WTInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0917786
Page 102 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 08:18:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 08:18:21
(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-15-2020 08:18:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 08:18:21
(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-15-2020 08:18:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020 08:18:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1GJ6Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-15-2020 08:18:35
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
BP1GJ6Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0917787
Page 103 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada)
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917788
Page 104 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-14-2020 15:26:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-14-2020 15:26:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-14-2020 15:26:35
(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-14-2020 15:26:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020 14:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-14-2020 15:26:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-14-2020 15:26:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917789
Page 105 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Sep-14-2020 15:26:35
(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-14-2020 15:26:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-14-2020 15:26:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917790
Page 106 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-14-2020 15:26:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJE
CTInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917791
Page 107 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 15:21:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917792
Page 108 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date:
Date Location User Value Reason
Oct-07-2020 15:21:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2.a
Date Location User Value Reason
Oct-07-2020 15:21:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-07-2020 15:21:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-07-2020 15:21:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-07-2020 15:21:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-07-2020 15:21:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (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-2021-5683-0917793
Page 109 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-07-2020 15:21:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-07-2020 15:21:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-07-2020 15:21:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-07-2020 15:21:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-07-2020 15:21:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-07-2020 15:21:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917794
Page 110 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-07-2020 15:21:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-07-2020 15:21:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-07-2020 15:21:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917795
Page 111 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 15:57:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 15:57:19
(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-07-2020 15:57:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 15:57:19
(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-07-2020 15:57:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020 15:57:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1SF3Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-07-2020 15:57:27
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
BP1SF3Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917796
Page 112 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada)
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917797
Page 113 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-07-2020 15:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-07-2020 15:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-07-2020 15:22:12
(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-07-2020 15:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020 13:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-07-2020 15:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-07-2020 15:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917798
Page 114 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Oct-07-2020 15:22:12
(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-07-2020 15:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-07-2020 15:22:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917799
Page 115 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-16-2020
17:03:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies query
Nov-16-2020
15:22:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredOriginal value is correct
Nov-13-2020
11:55:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies query
Nov-13-2020
09:58:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
wereddata is correct as entered,
subject rescheduled and came
in out of window for this visit
Nov-13-2020
06:08:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Op
enedDM: Kindly review and
complete ‘Immunogenicity
form' at this visit. Thank you.
Nov-13-2020
05:22:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 1 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. 
Nov-12-2020 ACV0PFEINFP6000  DataInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
(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-2021-5683-0917800
Page 116 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
16:13:00
(UTC-05:00)
Eastern Time
(US &
Canada)Entry
:
Nov/1
2/202
0
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917801
Page 117 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-13-2020 12:20:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-13-2020 12:20:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 12:20:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-13-2020 12:20:01
(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.
Nov-13-2020 12:20:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
Nov-13-2020 12:20:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR0KT5Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-13-2020 12:20:21
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
BR0KT5Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917802
Page 118 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada)
5.b
Date Location User Value Reason
Nov-13-2020 12:20:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR0KT6Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-13-2020 12:20:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR0KT6Initial Entry
5.c
Date Location User Value Reason
Nov-13-2020 12:20:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR0KT7Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-13-2020 12:20:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR0KT7Initial Entry
5.d
Date Location User Value Reason
Nov-13-2020 12:20:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLBSSMInitial Entry
5.d Sample ID
Date Location User Value Reason
Nov-13-2020 12:20:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLBSSMInitial Entry
5.e
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917803
Page 119 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Nov-13-2020 12:21:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLBSSNInitial Entry
5.e Sample ID
Date Location User Value Reason
Nov-13-2020 12:21:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLBSSNInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917804
Page 120 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-12-2020 16:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-12-2020 16:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-12-2020 16:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917805
Page 121 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Dec-18-2020 12:58:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917806
Page 122 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917807
Page 123 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917808
Page 124 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
Date Location User Value Reason
Dec-18-2020 13:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917809
Page 125 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Dec-18-2020 12:58:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-18-2020 12:58:18
(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
Dec-18-2020 12:58:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIZZINESSInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-11-2021 06:33:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-08-2021 11:56:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered no changes to this
ongoing AE
Jan-04-2021 08:49:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened GPD CLINQUERY:
Please confirm that
this adverse event is
still ongoing and
without change to
severity or update
information
accordingly.
Dec-18-2020 12:58:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020 21:00Initial Entry
5. Is the adverse event still ongoing?
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (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-2021-5683-0917810
Page 126 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Date Location User Value Reason
Jan-28-2021 16:35:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Jan-28-2021 15:58:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered site has attempted
contact with patient to
f/u on AE's and
contact has not been
established.
Jan-25-2021 10:40:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: Please
review if events
within listing (3)
remain ongoing. Else,
report end date and
update event outcome
status
Dec-18-2020 12:58:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-18-2020 12:58:18
(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
Dec-18-2020 12:58:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-18-2020 12:58:18
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917811
Page 127 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada)
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-18-2020 12:58:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-18-2020 12:58:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-18-2020 12:58:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-18-2020 12:58:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-18-2020 12:58:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-18-2020 12:58:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917812
Page 128 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-05-2021 13:36:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-05-2021 11:44:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered confirmed no mention
of any ear problems
via medical hx at
screen, etc until AE
Feb-05-2021 11:13:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened clinical: pls confirm
subject has no past
history of hearing
loss, episodes of
hearing loss, tinnitis
or other ear problems
or update MedHx
CRF accordingly.
Thanks
Jan-22-2021 10:27:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-22-2021 09:52:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered no improvement in
symptoms. Subject
still has not seen ENT
as advised.
Jan-22-2021 09:18:51
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Query 1: Opened clinical: pls advise if
subject has seen ENT
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (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-2021-5683-0917813
Page 129 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(US & Canada) or had audiometry
yet. Confirm subject
has not received any
treatment. Advise if
there have been any
improvement in
symptoms. Thanks
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HEARING LOSS IN RIGHT EARInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 04:39:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Mar-04-2021 12:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered yes as far as site is
aware. site has
attempted several
points of contact with
patient to check on
these to no avail
Mar-03-2021 13:06:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened GPD CLINQUERY:
Please confirm that
AE is still ongoing
and without change to
severity.
Dec-28-2020 11:43:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-22-2020 08:06:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered AE is still ongoing,
which is why this data
appears as such on the
eCRF page
Dec-21-2020 06:32:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sohil Patel Query 1: Opened ClinQuery: please
confirm if this AE is
still ongoing, if not
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917814
Page 130 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
please update as
appropriate.
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-18-2020 12:58:51
(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
Dec-28-2020 11:54:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-22-2020 08:06:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered temporal association.
The AE occurred
immediately
following
administration of
vaccine 2
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (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-2021-5683-0917815
Page 131 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Dec-21-2020 06:33:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sohil Patel Query 1: Opened ClinQuery: Please
explain why do you
consider this AE
related to study drug?
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-03-2021 08:28:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Mar-02-2021 15:31:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered patient has not
provided any updates
to site despite site's
several attempts at
contact
Feb-26-2021 10:47:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened clinical: pls confirm
still ongoing or
update end date on
CRF. Have you
received information
re audiometry?
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917816
Page 132 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Thanks
Jan-14-2021 13:47:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed clinical: site to update
when records
available.
Jan-13-2021 16:03:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered no further updates
available at this time.
site will update
accordingly as new
information is learned
Jan-08-2021 13:55:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened clinical: pls advise if
hearing loss was
based on subjective
report or on the basis
of audiometry.
Thanks
Jan-08-2021 11:57:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered subject planned to
follow up with ENT.
As of 1/08/2021 this
has not yet occurred.
Jan-06-2021 15:08:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened clinical: Thank you,
but please advise on
results of any testing
subject had to
determine hearing
loss, audiometry etc.
Was subject evaluated
by ENT?
Jan-06-2021 14:30:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered SC to f/u with patient
and EDC will be
updated as applicable.
Jan-05-2021 14:11:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened clinical: pls confirm
still ongoing or
update CRF with end
date. Pls also advise
on results of any
testing subject has
had done. Thanks
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0917817
Page 133 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Dec-18-2020 12:58:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917818
Page 134 of 145
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FALLInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/24/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-21-2020 11:34:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Dec-21-2020 11:23:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Dec-21-2020 11:23:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/24/2020 18:00New Information
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917819
Page 135 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Dec-21-2020 07:44:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: Fall is
a one-day event,
please review if an
end date can be
applied to this entry
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-18-2020 13:01:22
(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
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-18-2020 13:01:22
(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
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (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-2021-5683-0917820
Page 136 of 145
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-22-2020 08:07:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-22-2020 08:07:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDTranscription Error
Dec-21-2020 11:23:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE FALL:
Response to "What
was the outcome of
this adverse event?" is
'Not Recovered/Not
Resolved' but AE End
Date/Time is present.
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-18-2020 13:01:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (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-2021-5683-0917821
Page 137 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Category:
Date Location User Value Reason
Dec-18-2020 13:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-18-2020 13:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Dec-23-2020 14:06:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Dec-23-2020 13:45:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered data is correct.
required no
hospitalization and
does not interfere with
daily activities
Dec-22-2020 12:17:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Reissued:Opened CLINQUERY: Query
response doesn't
match question. Q:
Broken right arm is
reported as only
toxicity grade 1 and
not serious. Please
review and confirm
these entries are
correct i.e. no
hospitalisation and
doesn't impact on
activities
Dec-22-2020 08:14:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered AE resulted from fall
related to AE of
dizziness that has
been deemed related
to study drug per
Investigator due to
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917822
Page 138 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
temporal association
with vaccine.
Dec-21-2020 07:47:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: Broken
right arm is reported
as only toxicity grade
1 and not serious.
Please review and
confirm these entries
are correct
Dec-18-2020 13:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BROKEN RIGHT ARMInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-18-2020 13:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/24/2020 18:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 04:41:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-04-2021 12:57:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered yes as far as site is
aware. site has
attempted several
points of contact with
patient to check on
these to no avail
Mar-03-2021 13:07:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened GPD CLINQUERY:
Please confirm if AE
is still ongoing and
without change to
severity.
Dec-18-2020 13:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-18-2020 13:03:09 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0917823
Page 139 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
(UTC-05:00) Eastern Time
(US & Canada)1
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Dec-18-2020 13:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-18-2020 13:03:09
(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
Dec-28-2020 11:54:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-22-2020 08:15:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered due to temporal
association, having
occurred immediately
upon receiving
vaccine 2
Dec-21-2020 06:01:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sohil Patel Query 1: Opened ClinQuery: Please
explain why do you
consider this AE
related to study drug
Dec-18-2020 13:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0917824
Page 140 of 145
***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
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Dec-18-2020 13:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-18-2020 13:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-18-2020 13:03:09
(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
Dec-18-2020 13:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOLV
EDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-18-2020 13:03:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (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-2021-5683-0917825
Page 141 of 145
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: 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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-08-2021 13:54:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917826
Page 142 of 145
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-09-2021 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-09-2021 09:14:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened The response indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Feb-08-2021 13:55:01
(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-08-2021 13:55:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for Va
ccination 3
Participant is:
eligible and NOT confirmed to ha
ve received only placebo at Vacci
nation 1/2Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0917827
Page 143 of 145
***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: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-09-2021 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-09-2021 11:02:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADDI
TIONAL VACCINATIONInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0917828
Page 144 of 145
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-12-2020 16:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-14-2020 15:26:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-14-2020 15:25:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-12-2020 16:13:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/12/2020Initial Entry
Sep-14-2020 15:26:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/14/2020Initial Entry
Sep-14-2020 15:25:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/14/2020Initial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0917829
Page 145 of 145
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1057 Site Name: (1057) CNS Healthcare Jacksonville
Subject No: 10571188 Subject Initials: ---
Generated By: Generated Time (GMT): 19-Apr-2021 21:04
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1. Casebook Signature
Date Location User Value Reason
Nov-06-2020 12:27:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196d8902b\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0917830