125742 S1 M5 CRF c4591001 1252 12521011

Document text

Page 1 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834048
Page 2 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/17/2020
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834049
Page 3 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12521011]
2.Birth Date: 1935
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0834050
Page 4 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/17/2020
2.Erroneous Visit
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834051
Page 5 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion Not
MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834052
Page 6 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/17/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834053
Page 7 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety]
Start Date: Mar/4/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Chronic obstructive lung disease]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Insomnia]
Start Date: UNK/UNK/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Depression]
Start Date: Apr/9/2018
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypogonadism]
Start Date: UNK/UNK/2016
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Osteoarthritis in back]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834054
Page 8 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Gerd]
Start Date: UNK/UNK/2008
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Benign Prostatic Hyperplasia]
Start Date: UNK/UNK/2017
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Coronary artery disease]
Start Date: Apr/UNK/2018
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery/Non-Drug
Allergies/Drug Allergies:[Angioplasty]
Start Date: Apr/9/2018
Ongoing: NO
End Date:
Apr/9/2018
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834055
Page 9 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Aug/17/2020
2.Weight: [140.0]
3.Unit: LB
4.Height: [68.0]
5.Unit: in
6.Body Mass Index: [21.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834056
Page 10 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/17/2020
2.Randomization Number: [230752]
3.Randomization Group: [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834057
Page 11 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BNWG1M]
5.bSample ID [BNWG1N]
5.cSample ID [BPYXM3]
5.dSample ID [BPYXM4]
5.eSample ID [BPYXM5]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834058
Page 12 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/17/2020
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 [BPYXLT]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834059
Page 13 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: Aug/17/2020 16:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least the
protocol specified observation period
after investigational product
administration?YES
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834060
Page 14 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834061
Page 15 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834062
Page 16 of 401
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834063
Page 17 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BPYXZ7]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834064
Page 18 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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/9/2020 09:40
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
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834065
Page 19 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834066
Page 20 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/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 [BPYY3H]
5.bSample ID [BPYY3J]
5.cSample ID [BPYY3K]
5.dSample ID [BNWG4X]
5.eSample ID [BNWG4Y]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834067
Page 21 of 401
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834068
Page 22 of 401
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/10/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYY6P]
5.bSample ID [BNWG88]
5.cSample ID [BNWG89]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834069
Page 23 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834070
Page 24 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834071
Page 25 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834072
Page 26 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834073
Page 27 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834074
Page 28 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/11/2021
2.Date of First Symptom Started: Jan/6/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/10/2021
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? YES
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834075
Page 29 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Col
lectionSpecimen TypeSpecimen Collecti
on LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/6/2021  SWABBED MA
TERIAL NASOPHARYNX  SEVERE ACUTE RESP SYNDRO
ME CORONAVIRUS 2 SARS-COV-2 DIAGN
OSTIC TEST Repeating
Pages
 2.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834076
Page 30 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/6/2021 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: ABBOTT MOLECULAR REALTIME SARS-COV-2 ASSAY Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ABBOTT ID NOW SARS COV-2, NAAT, ID NOW] Comments
9.Trade Name Other, Specify: [ ] Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834077
Page 31 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1Actual Date of Collection Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834078
Page 32 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Jan/11/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV34600]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834079
Page 33 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[Nasal swab sample collected at the hospital when he was admitted on 06Jan2021 per
medical record.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834080
Page 34 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare Professional: SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare Professional: EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare Professional: PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare Professional: URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare Professional: TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare Professional: OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due to
potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834081
Page 35 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Jan/6/2021  NO
Discharge Date:
Jan/10/2021
 Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0834082
Page 36 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Jan/6/2021
4.Ongoing? NO
Discharge Date:
Jan/10/2021
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834083
Page 37 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment I
dentifierCon Non-Drug Treat
ments Pre-specifiedTreatment TreatmentStart
DateForm Instan
ce
 1.1  YES  NON-INVASIVE POSITIVE PR
ESSURE VENTILATION NON-INVASIVE POSITIVE PR
ESSURE VENTILATION Jan/6/
2021 Repeating
Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834084
Page 38 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: NON-INVASIVE POSITIVE PRESSURE VENTILATION
4.Treatment: [NON-INVASIVE POSITIVE PRESSURE VENTILATION]
5.Start Date: Jan/6/2021
6.Ongoing? NO
End Date:
Jan/10/2021
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834085
Page 39 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Not Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Pneumonia]
Date of Diagnosis:
Jan/6/2021
3.Toxicity Grade: 2
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834086
Page 40 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834087
Page 41 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event: Not Done Comments
3.Was a diagnosis obtained? Not Done Comments
4.Toxicity Grade: Not Done Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834088
Page 42 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.CLINICAL C
HEMISTRY McLeod Loris Hospital 3612 Mi
tchell Street Loris SC 29569 Jan/6/202
1 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
329  C Reactive Protein
_PX329 [ ] 
30  Alanine Aminotra
nsferase_PX30 [ ] 
28  Aspartate Aminotr
ansferase_PX28 [ ] 
35  Alkaline Phosphat
ase_PX35 65 
21  Bilirubin_PX21  0.5 
47  Blood Urea Nitrog
en_PX47 16 
48  Creatinine_PX48  0.96
 Repeating
Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834089
Page 43 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [McLeod Loris Hospital 3612 Mitchell Street Loris SC 29569]
3.Collection Date: Jan/6/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834090
Page 44 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [65]
Not Done:
LNMT Low
[50]
High
[250]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.1]
High
[1.2]
Unit
mg/dL
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [16]
Not Done:
LNMT Low
[9]
High
[20]
Unit
mg/dL
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834091
Page 45 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [0.96]
Not Done:
LNMT Low
[0.66]
High
[1.25]
Unit
mg/dL
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834092
Page 46 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor Name (DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.HEMATOLO
GY McLeod Loris Hospital 3612 Mitch
ell Street Loris SC 29569 Jan/6/202
1 BLOOD Sponsor-Define
d IdentifierTest:Res
ult:
1  Hemoglobin
_PX1 12.0 
2  Hematocrit_
PX2 36.2 
3  Erythrocytes
_PX3 [ ] 
5  Platelets_PX
5 214 
7  Leukocytes_
PX7 [ ] 
608  Neutrophils_
PX608 13.9 
609  Eosinophils_
PX609 0.0 
612  Monocytes_
PX612 0.9 
610  Basophils_P
X610 0.0 
611  Lymphocyte
s_PX611 1.1 Repeating
Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834093
Page 47 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [McLeod Loris Hospital 3612 Mitchell Street Loris SC 29569]
3.Collection Date: Jan/6/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [12.0]
Not Done:
LNMT Low
[14.0]
High
[18.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [36.2]
Not Done:
LNMT Low
[42.0]
High
[52.0]
Unit
%
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834094
Page 48 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [214]
Not Done:
LNMT Low
[150]
High
[450]
Unit
/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [13.9]
Not Done:
LNMT Low
[1.9]
High
[7.6]
Unit
10^9/L
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834095
Page 49 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.00]
High
[0.50]
Unit
10^9/L
5.hSponsor ID: [612]
Test: Monocytes_PX612
Result: [0.9]
Not Done:
LNMT Low
[0.2]
High
[1.5]
Unit
10^9/L
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[0.2]
Unit
10^9/L
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834096
Page 50 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [1.1]
Not Done:
LNMT Low
[1.1]
High
[4.8]
Unit
10^9/L
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834097
Page 51 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
 1.Jan/6/2021 Record Identifier: Systolic: Diastolic:
1  140  62 Repeating Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834098
Page 52 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/6/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [140]
Diastolic: [62]
Respiratory Rate in
respirations/minute:[20]
Heart Rate in beats/minute: [58]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834099
Page 53 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Date: Vital Signs Details Form Instance
 1.Jan/6/2021 Record Identifier: Oxygen Saturation
1  47.0 Repeating Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834100
Page 54 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/6/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [47.0]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834101
Page 55 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.Jan/6/2021 17:40  83  0.30  Repeating Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834102
Page 56 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Jan/6/2021 17:40 Comments
2.Arterial Blood Gases PaO2 (mmHg): [83] Comments
3.FiO2 (Fraction of Inhaled Oxygen): [0.30] Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834103
Page 57 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart DateForm Instanc
e
 1. DELETED [ ]      Not Applicable
 Not Applic
able Repeating
Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834104
Page 58 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834105
Page 59 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of Assessm
entLocation of Assessm
entImaging Meth
odOverall Assessment Form Instance
 1.Jan/6/2021  CHEST  X-RAY  ABNORMAL
If abnormal, specify findings:
Coarsened interstitium with nodular right lower lun
g density
 Repeating
Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834106
Page 60 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/6/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Coarsened interstitium with nodular right lower lung density]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834107
Page 61 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Feb/10/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834108
Page 62 of 401
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Feb/10/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/10/2021
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYY5K]
5.bSample ID [BNWG75]
5.cSample ID [BNWG74]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834109
Page 63 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834110
Page 64 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834111
Page 65 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834112
Page 66 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834113
Page 67 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834114
Page 68 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834115
Page 69 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1. ADVERSE EV
ENT 1  COPD exacerbation  Jan/6/2021 1
6:53 NO
End Date Time:
Jan/10/2021 10:10
 Repeating
Pages
 2. ADVERSE EV
ENT 2  Elevated Troponin  Jan/6/2021 1
6:53 NO
End Date Time:
Jan/10/2021 10:10
 Repeating
Pages
 3. ADVERSE EV
ENT 3  Sepsis  Jan/6/2021 1
6:53 NO
End Date Time:
Jan/10/2021 10:10
 Repeating
Pages
 4. DELETED ADVERSE EV
ENT 4  Pneumonia  Jan/6/2021 1
6:53 NO
End Date Time:
Jan/10/2021 10:10
 Repeating
Pages
 5. ADVERSE EV
ENT 5  Anemia  Jan/6/2021 1
6:53 NO
End Date Time:
Jan/10/2021 10:10
 Repeating
Pages
 6. ADVERSE EV
ENT 6  Hyperkalemia  Jan/6/2021 1
6:53 NO
End Date Time:
Jan/10/2021 10:10
 Repeating
Pages
 7. ADVERSE EV
ENT 7  Chronic Hypoxic respirator
y failure Jan/6/2021 1
6:53 NO
End Date Time:
Jan/10/2021 10:10
 Repeating
Pages
 8. ADVERSE EV
ENT 8  Low platelets  Jan/6/2021 1
6:53 NO
End Date Time:
Jan/10/2021 10:10
 Repeating
Pages
 9. ADVERSE EV
ENT 9  Low Lymphocytes  Jan/6/2021 1
6:53 NO
End Date Time:
Jan/10/2021 10:10Repeating
Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834116
Page 70 of 401
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834117
Page 71 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[COPD exacerbation]
4.Start Date Time: Jan/6/2021 16:53
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 10:10
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Increased shortness of breath]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834118
Page 72 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021015418]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834119
Page 73 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT Comments
2.AE ID: [2] Comments
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Elevated Troponin] Comments
4.Start Date Time: Jan/6/2021 16:53 Comments
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 10:10Comments
6.Toxicity Grade: 2 Comments
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 Comments
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 Comments
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Heart problem]Comments
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE Comments
11.Was a Concomitant Medication given? NO Comments
12.Was a Non-Drug Treatment given? NO Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834120
Page 74 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED Comments
14.Did the adverse event cause the subject
to be discontinued from the study?NO Comments
15.Serious Adverse Event Number: For
Pfizer Use Only[ ] Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834121
Page 75 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[Sepsis]
4.Start Date Time: Jan/6/2021 16:53
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 10:10
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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Probably due to Pneumonia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834122
Page 76 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834123
Page 77 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Not Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Pneumonia ]
4.Start Date Time: Jan/6/2021 16:53
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 10:10
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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834124
Page 78 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Not Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834125
Page 79 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Anemia]
4.Start Date Time: Jan/6/2021 16:53
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 10:10
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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Probably due to anemia of chronic disease and without any symptoms of bleeding.]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834126
Page 80 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834127
Page 81 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Hyperkalemia]
4.Start Date Time: Jan/6/2021 16:53
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 10:10
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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Potassium level high in blood]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834128
Page 82 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834129
Page 83 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Chronic Hypoxic respiratory failure]
4.Start Date Time: Jan/6/2021 16:53
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 10:10
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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Not enough of oxygen in the blood]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834130
Page 84 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834131
Page 85 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Low platelets]
4.Start Date Time: Jan/6/2021 16:53
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 10:10
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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Low number of platelets in blood]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834132
Page 86 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834133
Page 87 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Low Lymphocytes]
4.Start Date Time: Jan/6/2021 16:53
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/10/2021 10:10
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: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? NO
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834134
Page 88 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834135
Page 89 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryMedication Err
orStart DateIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.Not Applicab
le Not Applicable  Not Applicab
le Not Applicable  Not Applicable  Repeating
Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834136
Page 90 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Medication Error
1.Category: Not Applicable Comments
2.Medication Error (Type of Medication
Error):Not Applicable
[ ]Comments
3.Start Date: Not Applicable
//Comments
4.Is the medication error still ongoing? Not Applicable Comments
5.Latest Action Taken with Study
Treatment:Not Applicable Comments
6.Was a Concomitant Medication given? Not Applicable Comments
7.Was a Non-Drug Treatment given? Not Applicable Comments
8.Did the Medication Error cause the
subject to be discontinued from the
study?Not Applicable Comments
9.Was this medication error associated
with any adverse events?Not Applicable Comments
10.Serious Adverse Event Number: For
Pfizer Use OnlyNot Applicable
[ ]Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834137
Page 91 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Date Form Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applica
ble Repeating
Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834138
Page 92 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications Pre-specified: Not Applicable Comments
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Applicable
[ ]Comments
5.Date: Not Applicable
//Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834139
Page 93 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medica
tionDose Descrip
tionForm Instance
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Repeating
Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834140
Page 94 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications Pre-specified: Not Applicable Comments
4.Medication:
Provide the complete generic drug name
(including salt form, where applicable).
Where generic name is unknown, enter
the full trade or proprietary name.
Include clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).Not Applicable
[ ]Comments
5.Dose: Not Applicable
[ ]Comments
6.Dose Unit: Not Applicable Comments
7.Dose Frequency: Not Applicable Comments
8.Route: Not Applicable Comments
9.Start Date: Not Applicable
//Comments
10.Ongoing? Not Applicable Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834141
Page 95 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatment Start Date Form Instance
 1.Not Applicable
 Not Applicable  Not Applicable  Not Applicable
 Not Applicable
 Repeating Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834142
Page 96 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
Radiation Treatment
1.Category: Not Applicable Comments
2.What is the treatment Identifier? Not Applicable
[ ]Comments
3.Concomitant Non-drug Treatment
Pre-specified:Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834143
Page 97 of 401
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1. Not Applicable  Not Applicable  Repeating Pages
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834144
Page 98 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Form Comments
eCRF Audit Trail History
1.Transfusion Type: Not Applicable Comments
2.Date of Transfusion: Not Applicable
//Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834145
Page 99 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834146
Page 100 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834147
Page 101 of 401
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834148
Page 102 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834149
Page 103 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834150
Page 104 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834151
Page 105 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834152
Page 106 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834153
Page 107 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834154
Page 108 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834155
Page 109 of 401
***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, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834156
Page 110 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834157
Page 111 of 401
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834158
Page 112 of 401
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834159
Page 113 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/12/2020
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834160
Page 114 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834161
Page 115 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Stephen Grubb  Approved Mar-10-2021 16:29:06 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, 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.
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834162
Page 116 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormAug-21-2020 06:26:16 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834163
Page 117 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-13-2021 14:50:29 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
FormJan-11-2021 14:41:10 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834164
Page 118 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-13-2021 14:50:29 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
1Jan-11-2021 14:41:10 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834165
Page 119 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-13-2021 14:50:29 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
2Jan-11-2021 14:41:10 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834166
Page 120 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-13-2021 14:50:29 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
3Jan-11-2021 14:41:10 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834167
Page 121 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Jan-13-2021 14:50:29 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
4Jan-11-2021 14:41:10 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834168
Page 122 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Jan-13-2021 14:50:29 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
5Jan-11-2021 14:41:10 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834169
Page 123 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Jan-13-2021 14:50:29 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
6Jan-11-2021 14:41:10 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834170
Page 124 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Jan-13-2021 14:50:29 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
7Jan-11-2021 14:41:10 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834171
Page 125 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Jan-13-2021 14:50:29 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
8Jan-11-2021 14:41:10 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834172
Page 126 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Jan-13-2021 14:50:29 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
9Jan-11-2021 14:41:10 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834173
Page 127 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-18-2021 08:52:10 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
FormJan-18-2021 08:44:05 (UTC-05:00) Eastern Time (US
& Canada)Duplicate
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834174
Page 128 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-18-2021 08:52:10 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834175
Page 129 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-18-2021 08:52:10 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834176
Page 130 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-18-2021 08:52:10 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834177
Page 131 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Jan-18-2021 08:52:10 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834178
Page 132 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Jan-18-2021 08:52:10 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834179
Page 133 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Jan-18-2021 08:52:10 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834180
Page 134 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Jan-18-2021 08:52:10 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834181
Page 135 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Jan-18-2021 08:52:10 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834182
Page 136 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Jan-18-2021 08:52:10 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834183
Page 137 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-11-2021 15:00:11 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834184
Page 138 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-11-2021 15:00:32 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834185
Page 139 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: ILLNESS DETAILS - SEVERE - Comments
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Jan-11-2021 15:01:05 (UTC-05:00) Eastern Time (US
& Canada)Not done
Not Done
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834186
Page 140 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-11-2021 15:56:55 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834187
Page 141 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-11-2021 15:58:12 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834188
Page 142 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: OXYGENATION PARAMETERS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-11-2021 15:58:28 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834189
Page 143 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
4Jan-11-2021 16:00:13 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834190
Page 144 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
5Jan-11-2021 16:00:31 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834191
Page 145 of 401
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Jan/11/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS - Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
6Jan-11-2021 16:00:48 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834192
Page 146 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
FormJan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
FormJan-15-2021 09:38:45 (UTC-05:00) Eastern Time (US
& Canada)Transcription error
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834193
Page 147 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
1Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834194
Page 148 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
2Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
2Jan-15-2021 09:38:15 (UTC-05:00) Eastern Time (US
& Canada)Transcription error
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834195
Page 149 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
3Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834196
Page 150 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
4Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
4Jan-15-2021 09:39:14 (UTC-05:00) Eastern Time (US
& Canada)Transcription error
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834197
Page 151 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
5Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834198
Page 152 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
6Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834199
Page 153 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
7Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834200
Page 154 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
8Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834201
Page 155 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
9Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834202
Page 156 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
10Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834203
Page 157 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
11Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
11Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834204
Page 158 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
12Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
12Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834205
Page 159 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
13Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
13Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834206
Page 160 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
14Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
14Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834207
Page 161 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
15Jan-19-2021 15:51:07 (UTC-05:00) Eastern Time (US
& Canada)
15Jan-15-2021 09:44:21 (UTC-05:00) Eastern Time (US
& Canada)Not applicable
Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834208
Page 162 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-08-2021 10:30:47 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834209
Page 163 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-08-2021 10:30:47 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834210
Page 164 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-08-2021 10:30:47 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834211
Page 165 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-08-2021 10:30:47 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834212
Page 166 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Jan-08-2021 10:30:47 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834213
Page 167 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Jan-08-2021 10:30:47 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834214
Page 168 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Jan-08-2021 10:30:47 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834215
Page 169 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Jan-08-2021 10:30:47 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834216
Page 170 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Jan-08-2021 10:30:47 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834217
Page 171 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Jan-08-2021 10:30:47 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834218
Page 172 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Comments
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Jan-08-2021 10:30:47 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834219
Page 173 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-08-2021 10:31:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834220
Page 174 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-08-2021 10:31:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834221
Page 175 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-08-2021 10:31:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834222
Page 176 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-08-2021 10:31:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834223
Page 177 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Jan-08-2021 10:31:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834224
Page 178 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Jan-08-2021 10:31:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834225
Page 179 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-08-2021 10:31:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834226
Page 180 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-08-2021 10:31:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834227
Page 181 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-08-2021 10:31:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834228
Page 182 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-08-2021 10:31:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834229
Page 183 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Jan-08-2021 10:31:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834230
Page 184 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Jan-08-2021 10:31:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834231
Page 185 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Jan-08-2021 10:31:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834232
Page 186 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
7Jan-08-2021 10:31:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834233
Page 187 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
8Jan-08-2021 10:31:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834234
Page 188 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
9Jan-08-2021 10:31:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834235
Page 189 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
10Jan-08-2021 10:31:48 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834236
Page 190 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-08-2021 10:32:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834237
Page 191 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-08-2021 10:32:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834238
Page 192 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-08-2021 10:32:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834239
Page 193 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Jan-08-2021 10:32:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834240
Page 194 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Jan-08-2021 10:32:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834241
Page 195 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
5Jan-08-2021 10:32:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834242
Page 196 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
6Jan-08-2021 10:32:08 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834243
Page 197 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-08-2021 10:32:23 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834244
Page 198 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Jan-08-2021 10:32:23 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834245
Page 199 of 401
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Jan-08-2021 10:32:23 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834246
Page 200 of 401
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-15-2021 14:45:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834247
Page 201 of 401
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-15-2021 14:45:53 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834248
Page 202 of 401
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-15-2021 14:46:15 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834249
Page 203 of 401
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-15-2021 14:46:15 (UTC-05:00) Eastern Time (US
& Canada)Not Applicable
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834250
Page 204 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Stephen Grubb  Approved Mar-10-2021 16:29:06 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, 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 Mar-10-2021 15:47:16 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb  Approved Mar-03-2021 12:07:51 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, 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-26-2021 13:27:56 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb  Approved Feb-24-2021 16:22:48 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834251
Page 205 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, StephenGrubb, 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.
Debbra Scotti  N/A Feb-18-2021 09:27:11 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb  Approved Feb-16-2021 16:03:05 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, 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-15-2021 14:45:41 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb  Approved Feb-12-2021 14:23:20 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, 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-10-2021 10:42:25 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834252
Page 206 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
N/A
Stephen Grubb  Approved Feb-09-2021 11:55:47 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, 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-09-2021 08:15:52 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb  Approved Jan-29-2021 09:14:33 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-25-2021 03:39:20 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb  Approved Jan-24-2021 13:46:48 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834253
Page 207 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-18-2021 08:43:05 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb  Approved Jan-15-2021 11:23:31 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-12-2021 16:47:08 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Stephen Grubb  Approved Jan-11-2021 17:01:43 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, verify that all case report form pages accurately display the results of the examinations,
tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to
be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-08-2021 10:30:27 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834254
Page 208 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Affidavit:
N/A
Stephen Grubb  Approved Oct-21-2020 17:19:17 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StephenGrubb, 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.
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834255
Page 209 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-17-2020 22:31:36
(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
Aug-17-2020 22:31:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834256
Page 210 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-17-2020 22:32:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/17/2020Initial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834257
Page 211 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-17-2020 22:31:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12521011Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-17-2020 22:31:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1935Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-17-2020 22:32:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-17-2020 22:32:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR O
F SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-17-2020 22:32:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0834258
Page 212 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-26-2020 09:38:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed As per the update.
Aug-25-2020 17:47:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Aug-21-2020 11:10:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened IVRS Reconciliation:
Randomization date
and randomization
number recorded at
Impala but not recorded
at Inform. Please
review and update data
as appropriate. Else,
clarify. Thank you.
Aug-17-2020 22:33:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834259
Page 213 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-21-2020 06:26:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020 06:26:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020 06:26:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834260
Page 214 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020 17:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Term: Anxiety
Start Date: Mar/4/2019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:31:01
(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
Aug-25-2020 17:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
AnxietyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-25-2020 17:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/4/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020 17:31:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-25-2020 17:32:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2Initial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834261
Page 215 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Medical History
Term:Chronic obstructive lu
ng disease
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
FDA-CBER-2021-5683-0834262
Page 216 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:32:09
(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
Aug-31-2020 08:22:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Aug-28-2020 21:32:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is correct
Aug-27-2020 11:27:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened GPD Clin: Per IC3,
please confirm stability
of symptoms prior to
study enrolment; that
no significant change in
therapy or
hospitalization for
worsening of disease
within 6 weeks of
enrolment. Also,
confirm EC13 reviewed
(systemic corticosteroid
use)
Aug-25-2020 17:32:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Chronic obstructive lung diseaseInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020 17:32:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-25-2020 17:32:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834263
Page 217 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.c
Date Location User Value Reason
Aug-25-2020 17:41:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term
:Insomnia
Start Date: UNK/UNK/201
5
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:41:37
(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
Aug-25-2020 17:41:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
InsomniaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-25-2020 17:41:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-25-2020 17:41:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-25-2020 17:42:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Term: Depression
Start Date: Apr/9/2018Initial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834264
Page 218 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:42:21
(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
Aug-25-2020 17:42:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DepressionInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-25-2020 17:42:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/9/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-25-2020 17:42:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-25-2020 17:43:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Term
:Hypogonadism
Start Date: UNK/UNK/201
6
Ongoing: YESInitial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834265
Page 219 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:43:12
(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
Aug-25-2020 17:43:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypogonadismInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-25-2020 17:43:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-25-2020 17:43:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-15-2020 16:25:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 6
Medical History Te
rm:Osteoarthritis in b
ack
Start Date: UNK/UNK/2009
Ongoing: YESNew Information
Aug-25-2020 17:44:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:Osteoarthritis
Start Date: UNK/UNK/200
9
Ongoing: YESInitial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834266
Page 220 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.f Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:44:26
(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-16-2020 09:08:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-15-2020 16:25:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Sep-15-2020 16:25:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Osteoarthritis in backNew Information
Sep-14-2020 17:05:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Please
specify body site
location in the medical
history term
Osteoarthritis. Thank
you.
Aug-25-2020 17:44:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OsteoarthritisInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-25-2020 17:44:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-25-2020 17:44:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (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-2021-5683-0834267
Page 221 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Aug-25-2020 17:44:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Term
:Gerd
Start Date: UNK/UNK/200
8
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:44:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 17:44:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
GerdInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-25-2020 17:44:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-25-2020 17:44:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-25-2020 17:45:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:Benign Prostatic Hyp
erplasia
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834268
Page 222 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.h Line/MH Number:
Date Location User Value Reason
Aug-25-2020 17:45:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 17:45:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Benign Prostatic HyperplasiaInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-25-2020 17:45:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-25-2020 17:45:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-14-2020 15:49:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 9
Medical History Te
rm:Coronary artery dis
ease
Start Date: Apr/UNK/2018
Ongoing: YESInitial Entry
Sep-14-2020 15:49:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Te
rm:Coronary artery dis
ease
Start Date: Apr/UNK/2018
Ongoing:Initial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834269
Page 223 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.i
Date Location User Value Reason
Sep-14-2020 15:42:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number:
Medical History Term:
Start Date:
Ongoing:Transcription Error
Sep-14-2020 08:30:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number:
Medical History Term:
Start Date:
Ongoing:Duplicate data
(DELETED)
Sep-14-2020 08:29:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number:
Medical History Term:
Start Date:
Ongoing:Duplicate
Sep-10-2020 10:27:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:Stented Coronary Arter
y heart disease
Start Date: Apr/UNK/2018
Ongoing: NO
End Date:
Apr/UNK/2018Heart disease
Aug-25-2020 17:46:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Stented Coronary
Artery
Start Date: Apr/UNK/2018
Ongoing: NO
End Date:
Apr/UNK/2018Initial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834270
Page 224 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.i Line/MH Number:
Date Location User Value Reason
Sep-14-2020 15:49:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
Sep-14-2020 15:42:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-14-2020 08:30:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Duplicate data
(DELETED)
Sep-14-2020 08:29:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Duplicate
Aug-25-2020 17:46:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-14-2020 16:10:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Sep-14-2020 15:49:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Sep-14-2020 15:49:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Coronary artery diseaseInitial Entry
Sep-14-2020 15:42:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-14-2020 15:12:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Reissued:Opened CLINQUERY: Query
closed as 'duplicate' but
line entry previously
reported coronary
artery stent, now
deleted. Line below
reports angioplasty.
Please review data
change per prior
queries.
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834271
Page 225 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-14-2020 08:30:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Duplicate data
(DELETED)
Sep-14-2020 08:29:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Duplicate
Sep-14-2020 08:29:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Duplicate
Sep-14-2020 06:20:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Reissued:Opened CLINQUERY: Type of
heart disease or related
condition to coronary
artery stent/angioplasty
not captured in CRF.
Please clarify, add as a
separate line entry
Sep-11-2020 10:11:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Sep-11-2020 06:58:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Reissued:Opened CLINQUERY: Please
clarify the type of heart
disease (eg CAD?) and
move into a separate
line entry. Review if
ongoing.
Sep-10-2020 10:27:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Heart disease
Sep-10-2020 10:27:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Stented Coronary Artery heart diseaseHeart disease
Sep-02-2020 08:22:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: Please
review if the underlying
condition should be
reported as a separate
entry in the MH listing
Sep-02-2020 08:00:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Candidate CLINQUERY: Please
review if the underlying
condition should be
reported as a separate
entry in the MH listing
Aug-25-2020 17:46:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Stented Coronary ArteryInitial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0834272
Page 226 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.i Start Date:
Date Location User Value Reason
Sep-14-2020 15:49:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/UNK/2018Initial Entry
Sep-14-2020 15:42:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-14-2020 08:30:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Duplicate data
(DELETED)
Sep-14-2020 08:29:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Duplicate
Aug-25-2020 17:46:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/UNK/2018Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-14-2020 15:49:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
Sep-14-2020 15:42:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-14-2020 08:30:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Duplicate data
(DELETED)
Sep-14-2020 08:29:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Duplicate
Aug-25-2020 17:46:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Apr/UNK/2018Initial Entry
1.j
Date Location User Value Reason
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (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), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0834273
Page 227 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-11-2020 10:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Term: Angioplasty
Start Date: Apr/9/2018
Ongoing: NO
End Date:
Apr/9/2018Initial Entry
1.j Line/MH Number:
Date Location User Value Reason
Sep-11-2020 10:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-11-2020 10:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
AngioplastyInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-11-2020 10:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/9/2018Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-11-2020 10:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Apr/9/2018Initial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834274
Page 228 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 17:20:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-25-2020 17:20:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
140.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-25-2020 17:20:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-25-2020 17:20:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
68.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-25-2020 17:20:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-25-2020 17:20:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.3Initial Entry
7.a
Date Location User Value Reason
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (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-2021-5683-0834275
Page 229 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Aug-25-2020 17:20:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.2
Temperature Unit: F
Temperature Location
::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 17:20:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-25-2020 17:20:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-25-2020 17:20:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-25-2020 17:20:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (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-2021-5683-0834276
Page 230 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-25-2020 17:21:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-25-2020 17:21:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
230752Initial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834277
Page 231 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 06:27:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 06:27:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-21-2020 06:27:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-21-2020 06:27:17
(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.
Aug-21-2020 06:27:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/17/2020Initial Entry
5.a
Date Location User Value Reason
Aug-21-2020 06:27:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWG1MInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-21-2020 06:27:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNWG1MInitial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834278
Page 232 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b
Date Location User Value Reason
Aug-21-2020 06:27:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNWG1NInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-21-2020 06:27:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BNWG1NInitial Entry
5.c
Date Location User Value Reason
Aug-21-2020 06:27:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYXM3Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-21-2020 06:27:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYXM3Initial Entry
5.d
Date Location User Value Reason
Aug-21-2020 06:28:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYXM4Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-21-2020 06:28:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYXM4Initial Entry
5.e
Date Location User Value Reason
Aug-21-2020 06:28:48
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (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) (6)
(b) (4)
FDA-CBER-2021-5683-0834279
Page 233 of 401
***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: 1252 Site Name: (1252) Waterway Primary Care LLC DBA Tabor City Family
Medicine
Subject No: 12521011 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada) Sample ID: BPYXM5
5.e Sample ID
Date Location User Value Reason
Aug-21-2020 06:28:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYXM5Initial Entry
090177e196ae30e7\Final\Final On: 01-Apr-2021 04:19 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0834280
Page 234 of 401
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC S
…[truncated]