125742 S1 M5 CRF c4591001 1129 11291032

Document text

Page 1 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 version30 JUN 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800452
Page 2 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/3/2020
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800453
Page 3 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11291032]
2.Birth Date: /1948
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:
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800454
Page 4 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/3/2020
2.Erroneous Visit
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800455
Page 5 of 352
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion
criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55
years, inclusive, 65 and 85 years, inclusive, or 18 and 85 years,
inclusive, at randomization (dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all
scheduled visits, vaccination plan, laboratory tests, lifestyle
considerations, and other study procedures
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN02A00
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800456
Page 6 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history,
physical examination, and clinical judgment of the investigator
to be eligible for inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which
includes compliance with the requirements and restrictions
listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer
use only)IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past
year) or active suicidal ideation/behavior/lab abnormality that
may increase the risk of study participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX01A00
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800457
Page 7 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV),
hepatitis C virus (HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine
and/or severe allergic reaction (eg, anaphylaxis) to any
component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX04A00
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800458
Page 8 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected
immunodeficiency, as determined by history and/or
laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged
bleeding that would, in the opinion of the investigator,
contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX11A00
2.hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX12A00
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800459
Page 9 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as
cytotoxic agents or systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60
days before study intervention administration or planned
receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX14A01
2.kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention
within 28 days prior to study entry and/or during study
participation
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX15A01
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800460
Page 10 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study
intervention containing lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in
the conduct of the study, site staff otherwise supervised by the
investigator, and their respective family members
Criterion met? NO
Criterion ID: (For Pfizer
use only)EX21A01
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800461
Page 11 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800462
Page 12 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[seasonal allergies]
Start Date: UNK/UNK/1960
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[kidney stones]
Start Date: Feb/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[bilateral cataracts]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
Dec/UNK/2019
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800463
Page 13 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[asthma]
Start Date: UNK/UNK/1960
Ongoing: NO
End Date:
UNK/UNK/1982
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[osteoarthritis]
Start Date: UNK/UNK/2010
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[intermittent gout]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800464
Page 14 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[fracture right tibia]
Start Date: UNK/UNK/1963
Ongoing: NO
End Date:
UNK/UNK/1963
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[right fibula fracture]
Start Date: UNK/UNK/1963
Ongoing: NO
End Date:
UNK/UNK/1963
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Neck pain]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800465
Page 15 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[type 2 diabetes]
Start Date: UNK/UNK/2018
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[high cholesterol]
Start Date: UNK/UNK/2016
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[overweight]
Start Date: UNK/UNK/1980
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[high blood pressure]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800466
Page 16 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.nLine/MH Number: [14]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[abnormal electrocardiogram]
Start Date: UNK/UNK/2010
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Chronic major depression]
Start Date: UNK/UNK/1970
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[bilateral cataract surgery]
Start Date: Dec/UNK/2019
Ongoing: NO
End Date:
Dec/UNK/2019
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800467
Page 17 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.qLine/MH Number: [17]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[right shoulder replacement]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.rLine/MH Number: [18]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[bilateral shoulder surgery]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.sLine/MH Number: [19]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[surgical fixture c-3-4-5]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800468
Page 18 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.tLine/MH Number: [20]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[bilateral knee replacement]
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
UNK/UNK/2002
1.uLine/MH Number: [21]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[bilateral arthroscopic knee surgery x2]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
1.vLine/MH Number: [22]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[smoker]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800469
Page 19 of 352
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/3/2020
2.Weight: [226.6]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [32.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800470
Page 20 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/3/2020
2.Randomization Number: [221441]
3.Randomization Group: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800471
Page 21 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/3/2020
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 [BP5PZY]
5.bSample ID [BP5PZZ]
5.cSample ID [BP5R00]
5.dSample ID [BLD17W]
5.eSample ID [BLD17V]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800472
Page 22 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/3/2020
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 [BP5R26]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800473
Page 23 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/3/2020 10:50
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
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800474
Page 24 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800475
Page 25 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800476
Page 26 of 352
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800477
Page 27 of 352
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800478
Page 28 of 352
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800479
Page 29 of 352
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800480
Page 30 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BMB572]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800481
Page 31 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/24/2020 12:21
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
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800482
Page 32 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800483
Page 33 of 352
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800484
Page 34 of 352
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800485
Page 35 of 352
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800486
Page 36 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/21/2020
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 [BPC03L]
5.bSample ID [BPC03K]
5.cSample ID [BPC03J]
5.dSample ID [BLD0XT]
5.eSample ID [BLD0XV]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800487
Page 37 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800488
Page 38 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800489
Page 39 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800490
Page 40 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800491
Page 41 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800492
Page 42 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800493
Page 43 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800494
Page 44 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800495
Page 45 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800496
Page 46 of 352
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Unplanned Assessments
1.Assessments
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800497
Page 47 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/21/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800498
Page 48 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800499
Page 49 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800500
Page 50 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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 [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800501
Page 51 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
 1.ADVERS
E EVEN
T 1 fatigue  Jan/25/2021
UNK:UNK NO
End Date Time:
Jan/25/2021 U
NK:UNK
 Repeating
Pages
 2.ADVERS
E EVEN
T 2 vomiting  Jan/25/2021
UNK:UNK NO
End Date Time:
Jan/25/2021 U
NK:UNK
 Repeating
Pages
 3.ADVERS
E EVEN
T 3 generalized body ache  Jan/25/2021
UNK:UNK NO
End Date Time:
Jan/31/2021 U
NK:UNK
 Repeating
Pages
 4.ADVERS
E EVEN
T 4 chills  Jan/25/2021
UNK:UNK NO
End Date Time:
Jan/25/2021 U
NK:UNK
 Repeating
Pages
 5.ADVERS
E EVEN
T 5 mild fever  Jan/25/2021
UNK:UNK NO
End Date Time:Repeating
Pages
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800502
Page 52 of 352
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Insta
nce
Jan/25/2021 U
NK:UNK
 
 6.ADVERS
E EVEN
T 6 worsened degenerative
joint disease left shoul
der Feb/16/202
1 UNK:UN
K NO
End Date Time:
Feb/17/2021 U
NK:UNK
 Repeating
Pages
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800503
Page 53 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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)[fatigue]
4.Start Date Time: Jan/25/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/25/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800504
Page 54 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800505
Page 55 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800506
Page 56 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[vomiting]
4.Start Date Time: Jan/25/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/25/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800507
Page 57 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800508
Page 58 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800509
Page 59 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[generalized body ache]
4.Start Date Time: Jan/25/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/31/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800510
Page 60 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800511
Page 61 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800512
Page 62 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[chills]
4.Start Date Time: Jan/25/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/25/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800513
Page 63 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800514
Page 64 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800515
Page 65 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[mild fever]
4.Start Date Time: Jan/25/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/25/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800516
Page 66 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800517
Page 67 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800518
Page 68 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[worsened degenerative joint disease left shoulder]
4.Start Date Time: Feb/16/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/17/2021 UNK:UNK
6.Toxicity Grade: 3
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800519
Page 69 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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:
[degenerative joint disease]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800520
Page 70 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
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[2021195295]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800521
Page 71 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800522
Page 72 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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[ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800523
Page 73 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800524
Page 74 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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: //
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800525
Page 75 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800526
Page 76 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800527
Page 77 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800528
Page 78 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800529
Page 79 of 352
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800530
Page 80 of 352
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800531
Page 81 of 352
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800532
Page 82 of 352
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800533
Page 83 of 352
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800534
Page 84 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800535
Page 85 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800536
Page 86 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800537
Page 87 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800538
Page 88 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800539
Page 89 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/4/2021
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800540
Page 90 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800541
Page 91 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/4/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800542
Page 92 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/4/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLB4Z0]
5.bSample ID [BLB4Z1]
5.cSample ID [BRL3SJ]
5.dSample ID [BRL3SK]
5.eSample ID [BRL3SL]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800543
Page 93 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/4/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRL3PW]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800544
Page 94 of 352
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/4/2021 15:55
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
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800545
Page 95 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/4/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800546
Page 96 of 352
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800547
Page 97 of 352
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800548
Page 98 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800549
Page 99 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRMX0S]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800550
Page 100 of 352
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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/25/2021 13:16
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
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800551
Page 101 of 352
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800552
Page 102 of 352
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/22/2021
3.Comments: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800553
Page 103 of 352
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800554
Page 104 of 352
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800555
Page 105 of 352
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800556
Page 106 of 352
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800557
Page 107 of 352
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Feb/22/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800558
Page 108 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/21/2020
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800559
Page 109 of 352
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800560
Page 110 of 352
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800561
Page 111 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormJan-12-2021 15:39:22 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800562
Page 112 of 352
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-04-2021 14:08:01 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Koren Approved Jan-27-2021 21:37:34 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, 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-26-2021 09:49:09 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800563
Page 113 of 352
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
N/A
Michael
Koren Approved Jan-25-2021 18:05:56 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, 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-22-2021 15:02:29 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Koren Approved Jan-21-2021 17:51:38 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800564
Page 114 of 352
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Jan-12-2021 15:36:13 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Koren Approved Oct-14-2020 09:48:04 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800565
Page 115 of 352
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, MichaelKoren, 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 Sep-21-2020 12:05:50 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Koren Approved Sep-11-2020 12:06:12 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800566
Page 116 of 352
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, MichaelKoren, 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.
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800567
Page 117 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-03-2020
12:15:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-03-2020
12:15:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHOR
TSInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800568
Page 118 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-03-2020
12:15:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/3/2020Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800569
Page 119 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-03-2020
12:15:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11291032Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-03-2020
12:14:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1948Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-03-2020
12:15:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800570
Page 120 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:15:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-03-2020
12:15:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800571
Page 121 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-03-2020
12:15:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/3/2020Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800572
Page 122 of 352
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:1
Crit
erio
n D
escr
ipti
on:Male or femal
e participants
between the a
ges of 18 and
55 years, incl
usive, 65 and
85 years, incl
usive, or 18 a
nd 85 years, i
nclusive, at ra
ndomization (
dependent up
on study stage
)
Crit
erio
n m
et?:YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800573
Page 123 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN01A00
1.a Inclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Male or female part
icipants between the
ages of 18 and 55 y
ears, inclusive, 65 a
nd 85 years, inclusi
ve, or 18 and 85 yea
rs, inclusive, at rand
omization (dependeInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800574
Page 124 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
nt upon study stage)
1.a Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:2Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800575
Page 125 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crit
erio
n D
escr
ipti
on:Participants
who are willi
ng and able t
o comply wit
h all schedule
d visits, vacci
nation plan, l
aboratory test
s, lifestyle co
nsiderations,
and other stu
dy procedure
s
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (F
or P
fize
r us
e on
ly):IN02A00
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800576
Page 126 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b Inclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participants who are
willing and able to c
omply with all sche
duled visits, vaccina
tion plan, laboratory
tests, lifestyle consi
derations, and other
study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800577
Page 127 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:3
Crit
erio
n D
escr
ipti
on:Healthy parti
cipants who a
re determined
by medical hi
story, physica
l examination
, and clinical
judgment of t
he investigato
r to be eligibl
e for inclusio
n in the studyInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800578
Page 128 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crit
erio
n m
et?:YES
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:IN03A00
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800579
Page 129 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.c Inclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Healthy participants
who are determined
by medical history,
physical examinatio
n, and clinical judg
ment of the investig
ator to be eligible fo
r inclusion in the stu
dyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800580
Page 130 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Incl
usio
n N
um
ber:4
Crit
erio
n D
escr
ipti
on:Capable of gi
ving personal
signed inform
ed consent, w
hich includes
compliance w
ith the require
ments and res
trictions liste
d in the ICD
and in this pr
otocolInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800581
Page 131 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crit
erio
n m
et?:YES
Crit
erio
n ID
: (F
or P
fizer
use
only
):IN04A00
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800582
Page 132 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.d Inclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Capable of giving p
ersonal signed infor
med consent, which
includes complianc
e with the requirem
ents and restrictions
listed in the ICD an
d in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800583
Page 133 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Exc
lusi
on
Nu
mbe
r:1
Crit
erio
n D
escr
ipti
on:Other medica
l or psychiatri
c condition in
cl. recent (wit
hin past year)
or active suici
dal ideation/b
ehavior/lab a
bnormality th
at may increa
se the risk of
study particip
ationInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800584
Page 134 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crit
erio
n m
et?:NO
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Other medical or ps
ychiatric condition i
ncl. recent (within p
ast year) or active sInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800585
Page 135 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
uicidal ideation/beh
avior/lab abnormalit
y that may increase
the risk of study par
ticipation
2.a Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu2Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800586
Page 136 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
& Canada) mbe
r:
Crite
rion
Desc
ripti
on:Known infec
tion with hu
man immun
odeficiency
virus (HIV),
hepatitis C v
irus (HCV),
or hepatitis
B virus (HB
V)
Crite
rion
met?
:NO
Crite
rion
ID: (
For
Pfize
r use
only)
:EX02A00
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800587
Page 137 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.b Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Known infection wi
th human immunod
eficiency virus (HI
V), hepatitis C virus
(HCV), or hepatitis
B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800588
Page 138 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:3
Crit
erio
n D
escr
iptio
n:History of se
vere adverse
reaction asso
ciated with a
vaccine and/o
r severe aller
gic reaction (
eg, anaphylax
is) to any co
mponent of t
he study inter
vention(s)
Crit
erio
n m
et?:NOInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800589
Page 139 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX03A00
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800590
Page 140 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.c Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
History of severe ad
verse reaction assoc
iated with a vaccine
and/or severe allergi
c reaction (eg, anap
hylaxis) to any com
ponent of the study
intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800591
Page 141 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:4
Criteri
on Des
criptio
n:Receipt of
medicatio
ns intende
d to preve
nt COVID
-19
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX04A00Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800592
Page 142 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.d Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Receipt of medicati
ons intended to prev
ent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800593
Page 143 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:8
Crit
erio
n De
scri
ptio
n:Immunocom
promised indi
viduals with
known or sus
pected immu
nodeficiency,
as determine
d by history a
nd/or laborat
ory/physical
examination
Crit
erio
n m
et?:NOInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800594
Page 144 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX08A00
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800595
Page 145 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.e Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Immunocompromis
ed individuals with
known or suspected
immunodeficiency,
as determined by hi
story and/or laborat
ory/physical examin
ationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800596
Page 146 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:10
Crit
erio
n De
scri
ptio
n:Bleeding diat
hesis or condi
tion associate
d with prolon
ged bleeding
that would, in
the opinion o
f the investig
ator, contrain
dicate intram
uscular inject
ionInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800597
Page 147 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crit
erio
n m
et?:NO
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX10A00
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800598
Page 148 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.f Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Bleeding diathesis o
r condition associat
ed with prolonged b
leeding that would,
in the opinion of the
investigator, contrai
ndicate intramuscul
ar injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800599
Page 149 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:11
Criterio
n Descri
ption:Women
who are p
regnant o
r breastfe
eding
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX11A0
0Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800600
Page 150 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.g Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Women who are pre
gnant or breastfeedi
ngInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800601
Page 151 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:12
Criteri
on Desc
ription:Previous
vaccinatio
n with an
y coronav
irus vacci
ne
Criteri
on met
?:NO
Criteri
on ID: (
For Pfi
zer use
only):EX12A00Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800602
Page 152 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.h Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Previous vaccinatio
n with any coronavi
rus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800603
Page 153 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:13
Crite
rion
Desc
ripti
on:Subjects wh
o receive im
munosuppre
ssive therap
y, such as cy
totoxic agen
ts or systemi
c corticoster
oids
Crite
rion
met?
:NOInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800604
Page 154 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crite
rion
ID: (
For
Pfize
r use
only)
:EX13A01
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800605
Page 155 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.i Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Subjects who receiv
e immunosuppressi
ve therapy, such as
cytotoxic agents or
systemic corticoster
oidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800606
Page 156 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usio
n N
umb
er:15
Crit
erio
n De
scri
ptio
n:Receipt of bl
ood/plasma p
roducts or im
munoglobuli
n, from 60 da
ys before stu
dy interventi
on administra
tion or planne
d receipt thro
ughout the st
udy
Crit
erio
n m
et?:NOInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800607
Page 157 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crit
erio
n ID
: (F
or P
fizer
use
only
):EX14A01
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800608
Page 158 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.j Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Receipt of blood/pla
sma products or im
munoglobulin, from
60 days before stud
y intervention admi
nistration or planne
d receipt throughout
the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800609
Page 159 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800610
Page 160 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
2.k
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usio
n Nu
mbe
r:16
Crit
erio
n De
scrip
tion:Participation
in other stud
ies involving
study interve
ntion within
28 days prio
r to study ent
ry and/or dur
ing study par
ticipation
Crit
erio
n me
t?:NOInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800611
Page 161 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crit
erio
n ID
: (Fo
r Pfi
zer
use
only
):EX15A01
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800612
Page 162 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.k Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participation in oth
er studies involving
study intervention
within 28 days prio
r to study entry and
/or during study par
ticipationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800613
Page 163 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Excl
usion
Num
ber:17
Crite
rion
Desc
riptio
n:Previous pa
rticipation i
n other stud
ies involvin
g study inte
rvention co
ntaining lipi
d nanoparti
cles
Crite
rion
met?
:NOInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800614
Page 164 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crite
rion
ID: (
For
Pfize
r use
only)
:EX16A01
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800615
Page 165 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.l Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Previous participati
on in other studies i
nvolving study inte
rvention containing
lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800616
Page 166 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Exc
lusi
on
Nu
mb
er:22
Crit
erio
n D
escr
ipti
on:Investigator s
ite staff or Pfi
zer employee
s directly inv
olved in the c
onduct of the
study, site sta
ff otherwise s
upervised by
the investigat
or, and their r
espective fam
ily membersInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800617
Page 167 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Crit
erio
n m
et?:NO
Crit
erio
n I
D: (
For
Pfiz
er u
se o
nly)
:EX21A01
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800618
Page 168 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.m Exclusion Number:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Investigator site sta
ff or Pfizer employ
ees directly involve
d in the conduct of
the study, site staff
otherwise supervise
d by the investigato
r, and their respecti
ve family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800619
Page 169 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF
Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020
12:16:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800620
Page 170 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-03-2020
12:17:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-03-2020
12:17:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-03-2020
12:17:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800621
Page 171 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Aug-03-2020
12:18:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:seasonal
allergies
Start Date: UNK/U
NK/196
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:18:25
(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-03-2020
12:18:25
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
seasonal allergiesInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800622
Page 172 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Eastern Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-03-2020
12:18:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1960Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-03-2020
12:18:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-03-2020
12:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:kidney sto
nesInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800623
Page 173 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Date
:Feb/UNK/
2019
Ongoing: NO
End Date
:
UNK/U
NK/201
9
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800624
Page 174 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
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1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
12:20:01
(UTC-05:00)
Eastern Time (US
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1.b Start Date:
Date Location User Value Reason
Aug-03-2020
12:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
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(b) (4)
FDA-CBER-2021-5683-0800625
Page 175 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:20:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
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UNK/UNK/2019Initial Entry
1.c
Date Location User Value Reason
Aug-03-2020
12:34:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
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H Num
ber:3
Medical
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Term:bilateral
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Start D
ate:UNK/U
NK/201
7
Ongoin
g:NO
End D
ate:
Dec/
UNK
/2019Transcription
Error
Aug-03-2020
12:32:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Num
ber:3Transcription
Error
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800626
Page 176 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical
History
Term:cataracts
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ate:UNK/U
NK/201
7
Ongoin
g:NO
End D
ate:
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UNK
/2019
Aug-03-2020
12:20:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
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H Num
ber:3
Medical
History
Term:cataracts
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ate:Dec/UN
K/2019
Ongoin
g:NO
End D
ate:
Dec/
UNK
/2019Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800627
Page 177 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.c Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:20:49
(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-03-2020
12:34:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
bilateral cataractsTranscription
Error
Aug-03-2020
12:20:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cataractsInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-03-2020
12:32:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Transcription
Error
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800628
Page 178 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:20:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-03-2020
12:20:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/UNK/2019Initial Entry
1.d
Date Location User Value Reason
Aug-03-2020
12:21:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:asthma
Start Date
:UNK/UN
K/1960Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800629
Page 179 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date
:
UNK/U
NK/198
2
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800630
Page 180 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.d Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:21:19
(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-03-2020
12:21:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
asthmaInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-03-2020
12:21:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1960Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800631
Page 181 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:21:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1982Initial Entry
1.e
Date Location User Value Reason
Aug-03-2020
12:21:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:osteoarth
ritis
Start Date: UNK/U
NK/201
0
Ongoing: YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800632
Page 182 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.e Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:21:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
12:21:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
osteoarthritisInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-03-2020
12:21:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800633
Page 183 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:21:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-03-2020
12:22:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:intermitt
ent gout
Start Date: UNK/U
NK/200
5
Ongoing: YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800634
Page 184 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.f Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:22:14
(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-03-2020
12:22:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
intermittent goutInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-03-2020
12:22:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.f Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800635
Page 185 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:22:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-03-2020
12:23:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical H
istory Ter
m:fracture rig
ht tibia
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:UNK/UN
K/1963
Ongoing: NO
End Date
:
UNK/U
NK/196
3Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800636
Page 186 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.g Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:23:13
(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-03-2020
12:23:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
fracture right tibiaInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-03-2020
12:23:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1963Initial Entry
1.g Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800637
Page 187 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:23:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1963Initial Entry
1.h
Date Location User Value Reason
Aug-03-2020
12:24:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical H
istory Ter
m:right fibula
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:UNK/UN
K/1963
Ongoing: NO
End Date
:
UNK/U
NK/196
3Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
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(b) (4)
FDA-CBER-2021-5683-0800638
Page 188 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.h Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:24:00
(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-03-2020
12:24:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
right fibula fractureInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-03-2020
12:24:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1963Initial Entry
1.h Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800639
Page 189 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:24:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1963Initial Entry
1.i
Date Location User Value Reason
Aug-03-2020
13:31:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Numb
er:9
Medical
History
Term:Neck pai
n
Start Da
te:UNK/UN
K/2007
Ongoing
:NO
End Dat
e:
UNK/
UNK/
2010Initial Entry
Aug-03-2020
12:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Numb
er:9Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800640
Page 190 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical
History
Term:Neck pai
n
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te:
Ongoing
:NO
End Dat
e:
UNK/
UNK/
2010
Aug-03-2020
12:25:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:9
Medical His
tory Term:Neck
pain
Start Date:
Ongoing:Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800641
Page 191 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.i Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:25:02
(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-03-2020
12:25:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Neck painInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-03-2020
13:31:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800642
Page 192 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.i Ongoing:
Date Location User Value Reason
Aug-03-2020
12:38:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/201
0Initial Entry
1.j
Date Location User Value Reason
Aug-03-2020
12:25:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:10
Medical His
tory Term:type 2 di
abetes
Start Date: UNK/U
NK/201
8
Ongoing: YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800643
Page 193 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.j Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:25:27
(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-03-2020
12:25:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
type 2 diabetesInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-03-2020
12:25:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.j Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800644
Page 194 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:25:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Aug-03-2020
12:26:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:11
Medical His
tory Term:high cho
lesterol
Start Date: UNK/U
NK/201
6
Ongoing: YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800645
Page 195 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.k Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:26:01
(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-03-2020
12:26:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
high cholesterolInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-03-2020
12:26:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.k Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800646
Page 196 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:26:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-03-2020
12:26:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:12
Medical His
tory Term:overwei
ght
Start Date: UNK/U
NK/198
0
Ongoing: YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800647
Page 197 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.l Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:26:39
(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-03-2020
12:26:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
overweightInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-03-2020
12:26:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.l Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800648
Page 198 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:26:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-03-2020
12:28:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:13
Medical Hi
story Term
:high bloo
d pressur
e
Start Date: UNK/UN
K/2016
Ongoing: YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800649
Page 199 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.m Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:28:02
(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-03-2020
12:28:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
high blood pressureInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-03-2020
12:28:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.m Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800650
Page 200 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:28:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-03-2020
12:28:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:14
Medical
History T
erm:abnormal e
lectrocardi
ogram
Start Dat
e:UNK/UNK
/2010
Ongoing: YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800651
Page 201 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.n Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:28:40
(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-09-2020
23:14:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Katherine Liau Query 1: Closed Response
satisfies query
Sep-09-2020
16:48:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answe
redrecords received,
records did not
address abnormal
EKG
Aug-14-2020
15:03:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Katherine Liau Query 1: Reissu
ed:OpenedPage needs to be
unfrozen for site
edits.
Aug-12-2020
10:38:20
(UTC-05:00)ACV0PFEINFP6000  Query 1: Answe
redcorrect as
entered. Medical
records requested
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800652
Page 202 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Eastern Time
(US & Canada)to clarify
Aug-11-2020
17:36:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Katherine Liau Query 1: Opene
dPer MM review,
please provide
specific diagnosis
or abnormal
electrocardiogram
finding.
Aug-03-2020
12:28:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
abnormal electr
ocardiogramInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-03-2020
12:28:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-03-2020
12:28:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0800653
Page 203 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.o
Date Location User Value Reason
Aug-03-2020
12:30:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:15
Medical
History T
erm:Chronic m
ajor depres
sion
Start Dat
e:UNK/UN
K/1970
Ongoing: YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800654
Page 204 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.o Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:30:16
(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
Aug-03-2020
12:30:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Chronic major depr
essionInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-03-2020
12:30:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1970Initial Entry
1.o Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800655
Page 205 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:30:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Aug-03-2020
12:33:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:16
Medical
History T
erm:bilateral cat
aract surger
y
Start Dat
e:Dec/UNK/2
019
Ongoing: NO
End Date:
Dec/UN
K/2019Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800656
Page 206 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.p Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:33:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
12:33:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
bilateral cataract sur
geryInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-03-2020
12:33:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/UNK/2019Initial Entry
1.p Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800657
Page 207 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:33:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/UNK/2019Initial Entry
1.q
Date Location User Value Reason
Aug-03-2020
12:35:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:17
Medical
History
Term:right should
er replacem
ent
Start Dat
e:UNK/UNK/
2017
Ongoing: NO
End Date:
UNK/U
NK/2017Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800658
Page 208 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.q Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:35:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
12:35:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
right shoulder repla
cementInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-03-2020
12:35:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.q Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800659
Page 209 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:35:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.r
Date Location User Value Reason
Aug-03-2020
12:35:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:18
Medical
History T
erm:bilateral sho
ulder surger
y
Start Dat
e:UNK/UNK/
2015
Ongoing: NO
End Date:
UNK/U
NK/201
5Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800660
Page 210 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.r Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:35:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
12:35:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
bilateral shoulder su
rgeryInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-03-2020
12:35:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800661
Page 211 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.r Ongoing:
Date Location User Value Reason
Aug-03-2020
12:35:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/201
5Initial Entry
1.s
Date Location User Value Reason
Aug-03-2020
12:36:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:19
Medical
History T
erm:surgical fix
ture c-3-4-
5
Start Dat
e:UNK/UNK
/2010
Ongoing: NO
End Date:
UNK/U
NK/201
0Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800662
Page 212 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.s Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:36:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
12:36:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
surgical fixture c-3-
4-5Initial Entry
1.s Start Date:
Date Location User Value Reason
Aug-03-2020
12:36:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.s Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800663
Page 213 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:36:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.t
Date Location User Value Reason
Aug-03-2020
12:37:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:20
Medical
History T
erm:bilateral kne
e replaceme
nt
Start Dat
e:UNK/UNK/
2002
Ongoing: NO
End Date:
UNK/U
NK/2002Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800664
Page 214 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.t Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:37:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
12:37:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
bilateral knee replac
ementInitial Entry
1.t Start Date:
Date Location User Value Reason
Aug-03-2020
12:37:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.t Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800665
Page 215 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:37:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2002Initial Entry
1.u
Date Location User Value Reason
Aug-03-2020
12:37:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:21
Medica
l Histor
y Term:bilateral arthr
oscopic knee
surgery x2
Start D
ate:UNK/UNK/1
999
Ongoin
g:NO
End Date:
UNK/UN
K/1999Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800666
Page 216 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.u Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:37:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
12:37:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
bilateral arthroscopi
c knee surgery x2Initial Entry
1.u Start Date:
Date Location User Value Reason
Aug-03-2020
12:37:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1999Initial Entry
1.u Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800667
Page 217 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:37:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1999Initial Entry
1.v
Date Location User Value Reason
Aug-03-2020
13:31:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:22
Medical
History T
erm:smoker
Start Dat
e:UNK/
UNK/2
010
Ongoing: YESInitial Entry
Aug-03-2020
12:38:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:22
Medical Hist
ory Term:smo
ker
Start Date:
Ongoing: YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800668
Page 218 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.v Line/MH Number:
Date Location User Value Reason
Aug-03-2020
12:38:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-03-2020
12:38:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
smokerInitial Entry
1.v Start Date:
Date Location User Value Reason
Aug-03-2020
13:31:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.v Ongoing:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800669
Page 219 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:38:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800670
Page 220 of 352
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Aug-03-2020
12:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-03-2020
12:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
226.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-03-2020
12:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800671
Page 221 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-03-2020
12:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
70.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-03-2020
12:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-03-2020
12:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32.5Initial Entry
7.a
Date Location User Value Reason
Aug-03-2020
12:40:05
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Record Id 1Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800672
Page 222 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Eastern Time (US
& Canada)entifier::
Temperat
ure:98.8
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-03-2020
12:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-03-2020
12:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.8Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800673
Page 223 of 352
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
12:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-03-2020
12:40:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800674
Page 224 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-03-2020
12:40:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-03-2020
12:40:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
221441Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800675
Page 225 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-03-2020
12:40:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-03-2020
12:40:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-03-2020
14:11:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-03-2020
12:40:30ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0800676
Page 226 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-03-2020
12:40:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/3/2020Initial Entry
5.a
Date Location User Value Reason
Aug-03-2020
14:11:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP5PZ
YInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-03-2020
14:11:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5PZYInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800677
Page 227 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.b
Date Location User Value Reason
Aug-03-2020
14:11:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP5PZ
ZInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-03-2020
14:11:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5PZZInitial Entry
5.c
Date Location User Value Reason
Aug-03-2020
14:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP5R0
0Initial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800678
Page 228 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.c Sample ID
Date Location User Value Reason
Aug-03-2020
14:11:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5R00Initial Entry
5.d
Date Location User Value Reason
Aug-03-2020
14:19:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BLD17
WInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-03-2020
14:19:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLD17WInitial Entry
5.e
Date Location User Value Reason
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800679
Page 229 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-03-2020
14:19:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BLD17
VInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-03-2020
14:19:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLD17VInitial Entry
090177e196ae30b8\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0800680
Page 230 of 352
***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: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-03-2020
12:40:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-03-2020
12:40:39
(UTC-05:00)
E
…[truncated]