125742 S1 M5 CRF c4591001 1167 11671085

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
192
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814255
Page 2 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/28/2020
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814256
Page 3 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11671085]
2.Birth Date: /1947
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:
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814257
Page 4 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814258
Page 5 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814259
Page 6 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/28/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814260
Page 7 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: Aug/28/2017
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Benign Hyperplasia Prostate]
Start Date: Oct/10/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Chronic Gout]
Start Date: Aug/30/2016
Ongoing: YES
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814261
Page 8 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Type 2 Diabetes]
Start Date: Mar/9/2017
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hematochezia]
Start Date: Oct/8/2015
Ongoing: NO
End Date:
Jan/28/2016
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hyperlipidemia]
Start Date: Oct/10/2018
Ongoing: YES
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814262
Page 9 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypothyroidism]
Start Date: Oct/10/2018
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Paroxysmal Atrial Fibrillation]
Start Date: Oct/24/2012
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Coronary arteriosclerosis]
Start Date: Aug/13/2014
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Lumbar Radiculopathy]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814263
Page 10 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Peripheral Neuropathy]
Start Date: Aug/30/2016
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Mild Dementia]
Start Date: Jan/28/2019
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Macular degeneration]
Start Date: UNK/UNK/2018
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Iron Deficiency anemia]
Start Date: Aug/26/1998
Ongoing: YES
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814264
Page 11 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.oLine/MH Number: [15]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Acid Reflux disease]
Start Date: Aug/8/2012
Ongoing: YES
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814265
Page 12 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
2.Weight: [298.0]
3.Unit: LB
4.Height: [75.0]
5.Unit: in
6.Body Mass Index: [37.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814266
Page 13 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/28/2020
2.Randomization Number: [243383]
3.Randomization Group: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814267
Page 14 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BN6FJY]
5.bSample ID [BN6FJZ]
5.cSample ID [BN6FK0]
5.dSample ID [BL9ZHS]
5.eSample ID [BL9ZHT]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814268
Page 15 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BN6FDK]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814269
Page 16 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/28/2020 09:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814270
Page 17 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814271
Page 18 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/17/2020
2.Erroneous Visit
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814272
Page 19 of 192
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/17/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.2]
Unit: F
Temperature Location: EAR
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814273
Page 20 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BN6FT7]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814274
Page 21 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/17/2020 08:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814275
Page 22 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814276
Page 23 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
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 [BM9BPM]
5.bSample ID [BLB12D]
5.cSample ID [BLB12F]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814277
Page 24 of 192
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814278
Page 25 of 192
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814279
Page 26 of 192
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814280
Page 27 of 192
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814281
Page 28 of 192
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814282
Page 29 of 192
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814283
Page 30 of 192
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814284
Page 31 of 192
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814285
Page 32 of 192
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814286
Page 33 of 192
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814287
Page 34 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814288
Page 35 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814289
Page 36 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814290
Page 37 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814291
Page 38 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Ide
ntifierAdverse Eve
ntStart DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Unstable Angi
na Pectoris Oct/20/2020
UNK:UNK NO
End Date Time:
Oct/20/2020 UNK
:UNK
 Repeating
Pages
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814292
Page 39 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Unstable Angina Pectoris]
4.Start Date Time: Oct/20/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/20/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814293
Page 40 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
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:
[known Coronary artery disease]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814294
Page 41 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020410184]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814295
Page 42 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814296
Page 43 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with
Study Treatment:
6.Was a Concomitant
Medication given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error
cause the subject to be
discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814297
Page 44 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814298
Page 45 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814299
Page 46 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814300
Page 47 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814301
Page 48 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814302
Page 49 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment
Identifier?[ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814303
Page 50 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814304
Page 51 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814305
Page 52 of 192
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814306
Page 53 of 192
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814307
Page 54 of 192
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814308
Page 55 of 192
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814309
Page 56 of 192
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814310
Page 57 of 192
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814311
Page 58 of 192
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814312
Page 59 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/18/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814313
Page 60 of 192
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814314
Page 61 of 192
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814315
Page 62 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814316
Page 63 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/19/2021
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814317
Page 64 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814318
Page 65 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/19/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814319
Page 66 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
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 [BR1DP8]
5.bSample ID [BNVSKN]
5.cSample ID [BNVSKP]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814320
Page 67 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/19/2021
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 [BM9BM6]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814321
Page 68 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/19/2021 09:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814322
Page 69 of 192
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814323
Page 70 of 192
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
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 [BR1DTT]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814324
Page 71 of 192
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/10/2021 08:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814325
Page 72 of 192
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814326
Page 73 of 192
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814327
Page 74 of 192
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814328
Page 75 of 192
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814329
Page 76 of 192
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814330
Page 77 of 192
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814331
Page 78 of 192
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814332
Page 79 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/15/2020
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814333
Page 80 of 192
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814334
Page 81 of 192
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
David
Morin Approved Mar-09-2021 16:33:36 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidMorin, 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.
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814335
Page 82 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-28-2020 09:46:25 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814336
Page 83 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormJan-19-2021 09:13:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814337
Page 84 of 192
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
David
Morin Approved Mar-09-2021 16:33:36 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidMorin, 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 08:21:12 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David
Morin Approved Jan-21-2021 13:30:04 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814338
Page 85 of 192
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, DavidMorin, 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 13:49:07 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David
Morin Approved Oct-27-2020 09:30:27 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DavidMorin, 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.
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814339
Page 86 of 192
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
 N/A Oct-27-2020 07:53:45 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Emily
Morawski Approved Oct-23-2020 08:10:01 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EmilyMorawski, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Oct-23-2020 05:26:41 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
David
Morin Approved Oct-22-2020 15:35:04 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814340
Page 87 of 192
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, DavidMorin, 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.
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814341
Page 88 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-28-2020
09:43:20
(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-28-2020
09:43:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814342
Page 89 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-28-2020
09:43:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Aug/28/2020Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814343
Page 90 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-28-2020
09:43:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11671085Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-28-2020
09:43:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1947Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-28-2020
09:43:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814344
Page 91 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-28-2020
09:43:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR L
ATINO(A) OR OF SPA
NISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-28-2020
09:43:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814345
Page 92 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-28-2020
09:46:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814346
Page 93 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-28-2020
09:46:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-28-2020
09:46:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-28-2020
09:46:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814347
Page 94 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-28-2020
09:49:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Hypert
ension
Start Date: Aug/28
/2017
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:49:34
(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-28-2020
09:49:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814348
Page 95 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.a Start Date:
Date Location User Value Reason
Aug-28-2020
09:49:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2017Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-28-2020
09:49:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-28-2020
09:50:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History T
erm:Benign Hy
perplasia P
rostate
Start Dat
e:Oct/10/201
8
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814349
Page 96 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:50:04
(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-28-2020
09:50:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Benign Hyperplasia Pro
stateInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-28-2020
09:50:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/10/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-28-2020
09:50:04ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814350
Page 97 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
1.c
Date Location User Value Reason
Aug-28-2020
09:50:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Chronic
Gout
Start Date: Aug/30
/2016
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814351
Page 98 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:50:31
(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-28-2020
09:50:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Chronic GoutInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-28-2020
09:50:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/30/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-28-2020
09:50:31ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814352
Page 99 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
1.d
Date Location User Value Reason
Aug-28-2020
09:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Type 2
Diabetes
Start Date: Mar/9/2
017
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814353
Page 100 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.d Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:50:55
(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-28-2020
09:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type 2 DiabetesInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-28-2020
09:50:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/9/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-28-2020
09:50:55ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814354
Page 101 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
1.e
Date Location User Value Reason
Oct-27-2020
07:54:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:5
Medical Hi
story Term
:Hematoc
hezia
Start Date: Oct/8/20
15
Ongoing: NO
End Da
te:
Jan/2
8/201
6Transcription
Error
Oct-27-2020
07:53:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:5
Medical Hi
story Term
:Hematoc
hezia
Start Date: Oct/8/20
15New
Information
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814355
Page 102 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Ongoing: NO
End Da
te:
Jan/2
8/201
5
Aug-28-2020
09:51:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:Hemato
chezia
Start Date: Oct/8/2
015
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814356
Page 103 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.e Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:51:20
(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
Oct-27-2020
10:02:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response
satisfies query
Oct-27-2020
07:56:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered answered
Oct-27-2020
05:16:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued:
OpenedThanks for the
response, form
has been
unfreeze, please
update as per
below query
Oct-26-2020
16:45:10
(UTC-05:00)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Reissued:
CandidateGPDClin:
Please unfreeze
MHx module,
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0814357
Page 104 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)so the site can
make changes.
Oct-26-2020
14:49:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered The page is
frozen
Oct-26-2020
11:19:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Reissued:
OpenedGPDClin: 1) If
hematochezia
had resolved,
please add End
Date. 2) Acid
reflux disease
was still not
added in the
MHx, please
add it.
Oct-26-2020
07:14:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered hematochezia
had resolved
Oct-23-2020
15:15:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Reissued:
OpenedGPDClin;
Thank you for
the
clarification!
Further
clarification
needed: The
subject had both
acid reflux
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0814358
Page 105 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
disease and
hematochezia,
or just
hematochezia?
If both, please
add acid reflux
as a separate
MHx, if only
one of them,
have correct
term here.
Oct-23-2020
08:06:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered Going to change
the omeprazole
to acid reflux
disease
Oct-22-2020
17:01:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin:
Please clarify
the term and the
underlying
cause. Per SAE
report,
omeprazole has
been used from
02Feb2015 for
it. However,
omeprazole is
used for upper
GI tract
bleeding instead
of lower GI
tract bleeding.
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0814359
Page 106 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-28-2020
09:51:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HematocheziaInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-28-2020
09:51:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2015Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-27-2020
07:54:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-27-2020
07:54:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/28/2016Transcription
Error
Oct-27-2020
07:53:45
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For Term
Hematochezia
End Date is
prior to Start
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814360
Page 107 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
& Canada) Date.
Oct-27-2020
07:53:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/28/2015New
Information
Aug-28-2020
09:51:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-28-2020
09:51:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:Hyperli
pidemia
Start Date: Oct/10/2
018
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814361
Page 108 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.f Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:51:42
(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
Aug-28-2020
09:51:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HyperlipidemiaInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-28-2020
09:51:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/10/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-28-2020
09:51:42ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814362
Page 109 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
1.g
Date Location User Value Reason
Aug-28-2020
09:52:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical His
tory Term:Hypothy
roidism
Start Date: Oct/10/2
018
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814363
Page 110 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.g Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:52:06
(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-28-2020
09:52:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HypothyroidismInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-28-2020
09:52:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/10/2018Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814364
Page 111 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.g Ongoing:
Date Location User Value Reason
Aug-28-2020
09:52:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-28-2020
09:52:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical
History T
erm:Paroxysmal
Atrial Fibri
llation
Start Dat
e:Oct/24/201
2
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814365
Page 112 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.h Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:52:40
(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-28-2020
09:52:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Paroxysmal Atrial Fibri
llationInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-28-2020
09:52:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/24/2012Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-28-2020
09:52:40ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814366
Page 113 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
1.i
Date Location User Value Reason
Aug-28-2020
09:53:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical
History T
erm:Coronary
arterioscle
rosis
Start Date
:Aug/13/20
14
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814367
Page 114 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.i Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:53:13
(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
Aug-28-2020
09:53:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Coronary arterioscleros
isInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-28-2020
09:53:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2014Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-28-2020
09:53:13ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814368
Page 115 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
1.j
Date Location User Value Reason
Aug-28-2020
09:53:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical H
istory Ter
m:Lumbar R
adiculopat
hy
Start Date
:UNK/UN
K/2010
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814369
Page 116 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.j Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:53:48
(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
Aug-28-2020
09:53:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Lumbar RadiculopathyInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-28-2020
09:53:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-28-2020
09:53:48ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814370
Page 117 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
1.k
Date Location User Value Reason
Aug-28-2020
09:55:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:11
Medical H
istory Ter
m:Peripheral
Neuropath
y
Start Date
:Aug/30/2
016
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814371
Page 118 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.k Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:55:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
09:55:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Peripheral NeuropathyInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-28-2020
09:55:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/30/2016Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-28-2020
09:55:01ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814372
Page 119 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
1.l
Date Location User Value Reason
Aug-28-2020
09:55:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:12
Medical His
tory Term:Mild De
mentia
Start Date: Jan/28/2
019
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814373
Page 120 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.l Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:55:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
09:55:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mild DementiaInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-28-2020
09:55:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/28/2019Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-28-2020
09:55:44ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814374
Page 121 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
1.m
Date Location User Value Reason
Aug-28-2020
09:56:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:13
Medical H
istory Ter
m:Macular d
egeneratio
n
Start Date
:UNK/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814375
Page 122 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.m Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:56:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
09:56:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Macular degenerationInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-28-2020
09:56:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-28-2020
09:56:11ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814376
Page 123 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
1.n
Date Location User Value Reason
Aug-28-2020
09:57:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:14
Medical H
istory Ter
m:Iron Defic
iency ane
mia
Start Date
:Aug/26/19
98
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814377
Page 124 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.n Line/MH Number:
Date Location User Value Reason
Aug-28-2020
09:57:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-01-2020
15:04:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies
query
Sep-01-2020
12:20:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered this was
verified as no
Sep-01-2020
02:32:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened GPDClin:
Anemia
reported:
Please
confirm if
subject has
received any
blood
products in
the past 60
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814378
Page 125 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
days for this
medhx.
Aug-31-2020
16:45:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Candidate GPDClin:
Anemia
reported:
Please
confirm if
subject has
received any
blood
products in
the past 60
days for this
medhx.
Aug-28-2020
09:57:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Iron Deficiency ane
miaInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-28-2020
09:57:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/1998Initial Entry
1.n Ongoing:
Date Location User Value Reason
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814379
Page 126 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-28-2020
09:57:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Oct-27-2020
07:56:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:15
Medical Hi
story Term
:Acid Refl
ux diseas
e
Start Date: Aug/8/20
12
Ongoing: YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814380
Page 127 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.o Line/MH Number:
Date Location User Value Reason
Oct-27-2020
07:56:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-27-2020
07:56:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Acid Reflux diseaseInitial Entry
1.o Start Date:
Date Location User Value Reason
Oct-27-2020
07:56:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/8/2012Initial Entry
1.o Ongoing:
Date Location User Value Reason
Oct-27-2020
07:56:02ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814381
Page 128 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814382
Page 129 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020
09:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-28-2020
09:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
298.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-28-2020
09:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814383
Page 130 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-28-2020
09:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
75.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-28-2020
09:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-28-2020
09:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
37.2Initial Entry
7.a
Date Location User Value Reason
Aug-28-2020
09:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperatur
e:97.2Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814384
Page 131 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Temperatur
e Unit:F
Temperatur
e Location::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-28-2020
09:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-28-2020
09:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-28-2020
09:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814385
Page 132 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
7.a Temperature Location:
Date Location User Value Reason
Aug-28-2020
09:48:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814386
Page 133 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-28-2020
09:57:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-28-2020
09:57:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
243383Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814387
Page 134 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020
09:57:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020
09:57:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
09:58:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-28-2020
09:57:35
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814388
Page 135 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-28-2020
09:57:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020
09:58:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6FJYInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
09:58:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6FJYInitial Entry
5.b
Date Location User Value Reason
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814389
Page 136 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-28-2020
09:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6FJZInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-28-2020
09:58:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6FJZInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020
09:58:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6FK0Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-28-2020
09:58:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6FK0Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814390
Page 137 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d
Date Location User Value Reason
Aug-28-2020
09:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9ZHSInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-28-2020
09:58:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9ZHSInitial Entry
5.e
Date Location User Value Reason
Aug-28-2020
09:59:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9ZHTInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814391
Page 138 of 192
***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: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.e Sample ID
Date Location User Value Reason
Aug-28-2020
09:59:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BL9ZHTInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814392
Page 139 of 192
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020
09:58:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020
09:58:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-28-2020
09:58:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814393
Page 140 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-28-2020
09:59:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BN6FD
KTranscription
Error
Aug-28-2020
09:58:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6FJYInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-28-2020
09:59:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6FDKTranscription
Error
Aug-28-2020
09:58:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6FJYInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814394
Page 141 of 192
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020
10:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020
10:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020
10:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814395
Page 142 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-28-2020
10:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 09:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020
10:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-28-2020
10:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-28-2020
10:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814396
Page 143 of 192
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-28-2020
10:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-28-2020
10:00:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814397
Page 144 of 192
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-28-2020
10:00:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICI
TY E-DIARY NOT CO
LLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814398
Page 145 of 192
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020
08:27:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814399
Page 146 of 192
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020
08:28:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020Initial Entry
2.a
Date Location User Value Reason
Sep-17-2020
08:28:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 97.
2
Temperature Uni
t:F
Temperature Loc
ation::EA
RInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-17-2020
08:28:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814400
Page 147 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.a Temperature:
Date Location User Value Reason
Sep-17-2020
08:28:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-17-2020
08:28:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-17-2020
08:28:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814401
Page 148 of 192
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020
08:28:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020
08:28:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020
08:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-17-2020
08:28:18
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814402
Page 149 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-17-2020
08:28:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/17/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
08:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN6FT7Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
08:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN6FT7Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814403
Page 150 of 192
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020
08:28:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020
08:28:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020
08:28:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814404
Page 151 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-17-2020
08:30:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020 08:30Transcription
Error
Sep-17-2020
08:28:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/17/2020 08:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020
08:28:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020
08:30:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814405
Page 152 of 192
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Sep-17-2020
08:28:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020
08:28:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-17-2020
09:02:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814406
Page 153 of 192
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020
10:46:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814407
Page 154 of 192
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020
10:46:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020
10:46:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020
10:46:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-15-2020
10:46:42
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814408
Page 155 of 192
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-15-2020
10:46:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020
10:46:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BM9BP
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020
10:46:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM9BPMInitial Entry
5.b
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814409
Page 156 of 192
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-15-2020
10:47:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BLB12
DInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020
10:47:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLB12DInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020
10:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BLB12
FInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814410
Page 157 of 192
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Oct-15-2020
10:47:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLB12FInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814411
Page 158 of 192
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-15-2020
10:47:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020
10:47:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-15-2020
10:47:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814412
Page 159 of 192
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814413
Page 160 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Unstable Angina Pector
isInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814414
Page 161 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/20/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-21-2020
12:04:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814415
Page 162 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Oct-23-2020
05:23:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Deleted event recorded in
SDB
Oct-22-2020
07:31:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Candidate SAE RECON:
Unstable Angina
Pectoris(Onset
date:20Oct2020)
is not reported to
Safety database
but marked
serious on AE
CRF. Confirm
seriousness and
report to Pfizer
immediately. If
this event is not
serious,
downgrade the
event on AE
CRF
Oct-22-2020
07:30:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed
internally
Oct-21-2020
10:33:33
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Unstable
Angina Pectoris:
Response to "Is
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814416
Page 163 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious eve
nt associated with
congenital anomal
y or birth defect?
NO
Did this serious ev
ent result in death
?
NO
Did this serious ev
ent require or prol
ong hospitalizatio
n?
YES
Did this serious ev
ent result in persis
tent or significant
disability/incapaci
ty?Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814417
Page 164 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
NO
Is this serious eve
nt life threatening?
NO
Other medically i
mportant serious e
vent
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.
Date Location User Value Reason
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-21-2020
12:05:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this ev
ent is due to:
OTHERNew
Information
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814418
Page 165 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
If Other, specify:
known Coronary
artery disease
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814419
Page 166 of 192
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-21-2020
10:33:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-23-2020
05:26:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2020410184Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814420
Page 167 of 192
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-18-2021
13:49:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814421
Page 168 of 192
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-18-2021
13:49:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to
return for Vaccination 3
Participant is:
eligible per local/nat
ional recommendati
ons and confirmed t
o have received only
placebo at Vaccinati
on 1/2Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814422
Page 169 of 192
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-18-2021
13:49:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-18-2021
13:49:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILIT
Y FOR ADDITIONAL
VACCINATIONInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814423
Page 170 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021
09:12:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814424
Page 171 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-19-2021
09:13:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Jan/19/2021Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814425
Page 172 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-19-2021
09:13:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-19-2021
09:13:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Jan-19-2021
09:13:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814426
Page 173 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021
09:13:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021
09:13:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021
09:14:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-19-2021
09:13:50
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814427
Page 174 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-19-2021
09:13:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Jan/19/2021Initial Entry
5.a
Date Location User Value Reason
Jan-19-2021
09:14:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR1DP
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-19-2021
09:14:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR1DP8Initial Entry
5.b
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814428
Page 175 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Jan-19-2021
09:14:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNVSK
NInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-19-2021
09:14:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNVSKNInitial Entry
5.c
Date Location User Value Reason
Jan-19-2021
09:14:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BNVSK
PInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814429
Page 176 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Jan-19-2021
09:14:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BNVSKPInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814430
Page 177 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-19-2021
09:14:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021
09:14:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021
09:15:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-19-2021
09:14:45
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814431
Page 178 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-19-2021
09:14:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Jan/19/2021Initial Entry
5.a
Date Location User Value Reason
Jan-19-2021
09:15:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BM9BM
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-19-2021
09:15:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM9BM6Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814432
Page 179 of 192
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-19-2021
09:42:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-19-2021
09:42:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-19-2021
09:42:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814433
Page 180 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Jan-19-2021
09:42:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021 09:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-19-2021
09:42:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-19-2021
09:42:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-19-2021
09:42:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814434
Page 181 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
8. Actual Dose:
Date Location User Value Reason
Jan-19-2021
09:42:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-19-2021
09:42:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-19-2021
09:42:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jan-19-2021
09:42:46ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0814435
Page 182 of 192
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814436
Page 183 of 192
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021
08:21:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814437
Page 184 of 192
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021
08:21:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021
08:21:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021
08:21:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-10-2021
08:21:26
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814438
Page 185 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-10-2021
08:21:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/10/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021
08:21:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR1DTTInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-10-2021
08:21:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR1DTTInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814439
Page 186 of 192
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-10-2021
08:36:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-10-2021
08:36:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-10-2021
08:36:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814440
Page 187 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Feb-10-2021
08:36:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021 08:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-10-2021
08:36:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-10-2021
08:36:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-10-2021
08:36:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814441
Page 188 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
8. Actual Dose:
Date Location User Value Reason
Feb-10-2021
08:36:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-10-2021
08:36:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-10-2021
08:36:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-10-2021
09:22:57ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814442
Page 189 of 192
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814443
Page 190 of 192
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-15-2020
10:47:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-28-2020
09:57:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-28-2020
09:46:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-15-2020
10:47:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
Aug-28-2020
09:57:23ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814444
Page 191 of 192
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-05:00)
Eastern Time (US
& Canada)
Aug-28-2020
09:46:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/28/2020Initial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814445
Page 192 of 192
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1167 Site Name: (1167) Holston Medical Group
Subject No: 11671085 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020
11:08:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3088\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814446
Related across Profoundd

Epstein Files

EFTA00128379 — Examination Notes for 2019-010614
Examination Notes for 2019-010614 New AUX assigned for the Analysis of two Desktop Computers Review AUX Request in LIMA Search Authority is Administrative Images Received from ASAC Sent via Apricorn Drive Images: Z6E8KD3…
EFTA01428839 — Customer: Southern Trust Company, Inc. — Salesforce - Unlimited Edition
Customer: Southern Trust Company, Inc. — Salesforce - Unlimited Edition Page 1 of 4 Cynthia Rodriguez Home Leads Customers Contacts Opportunities Cases Products Reports Search Go! Limit to items I own Advanced Search. ..…
EFTA00289950 — Electronic and digital signatures in Adobe Sign for government white
Electronic and digital signatures in Adobe Sign for government white paper With Adobe Sign, you can comply with laws and regulatory guidelines —using one scalable signature solution. Government organizations around the w…
Federal Writers' Project

[Mining Lore of Waldo]
WPI L. C. PROJE'CT UNIT e-Ife ,:f-S Accession n3. W 9.0 Date received /y 0 Consignment no. Shipped from Label Amount AA. Form -3 0.%Lee(7,e. Collection (or Type) Title.. Place of origin Date atel Project worker e Project…
[Mr. Obe Adams]
ca -r) ITOLKLORE-WHITE PIONEER, Miss. Effie Cowan,P.W. IcLennan County, Texas, District p. NO. of.Words :Pile NO.240. Page NO.1. REFERENCE. "Interview with 1,ir Obe Adams, Mart, Texas. I was born in 1857 in Grimes County…
[Folkways, and Social Customs]
Accession no. W UNIT Form -3 0eAf-,7_4_ Collection (or Type) Date received /0/r.o/re. Consignment no. Shipped from Label Amount Title ..7‘;-erf-1-0,-07.-0.-• Place of origin Date./0,/-17 Project worker Project editor Rem…
Recent News

FDA Knew COVID Vaccine Safety Monitoring System Was ‘Not Sufficient,’ Latest Pfizer Documents Confirm
You must be a CHD Insider to save this article Sign Up Already an Insider? Log in The U.S. Food and Drug Administration this week released its last batch of files related to the licensing of Pfizer’s COVID-19 vaccine for…
FDA Knew COVID Vaccine Safety Monitoring System Was ‘Not Sufficient,’ Latest Pfizer Documents Confirm
You must be a CHD Insider to save this article Sign Up Already an Insider? Log in The U.S. Food and Drug Administration this week released its last batch of files related to the licensing of Pfizer’s COVID-19 vaccine for…
You Are Part of An Experiment in Consent and Choice
This is a member's only feature. Please join or upgrade Originally published on www.standforhealthfreedom.com As summer melts into fall, informed consent is on the line, with FDA approval of the Pfizer vaccine expected b…