125742 S1 M5 CRF c4591001 1129 11291138

Document text

Page 1 of 263
***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: 11291138 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 version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802562
Page 2 of 263
***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: 11291138 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/25/2020
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802563
Page 3 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11291138]
2.Birth Date: /1953
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:
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802564
Page 4 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802565
Page 5 of 263
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 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
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802566
Page 6 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802567
Page 7 of 263
***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: 11291138 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:[Penicillin allergy]
Start Date: UNK/UNK/1958
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Prednisone allergy]
Start Date: UNK/UNK/1973
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Kenalog allergy]
Start Date: UNK/UNK/1973
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Strawberry allergy]
Start Date: UNK/UNK/1953
Ongoing: YES
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802568
Page 8 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Nut allergy]
Start Date: UNK/UNK/1975
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[steroid responder]
Start Date: Oct/29/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Norvasc allergy]
Start Date: UNK/UNK/2017
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: UNK/UNK/2003
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fatty liver disease]
Start Date: Feb/11/2003
Ongoing: YES
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802569
Page 9 of 263
***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: 11291138 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:[Ocular ischemic syndrome]
Start Date: UNK/UNK/2018
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Open angle glaucoma]
Start Date: UNK/UNK/2018
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left sided cataracts]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[partial detached retina left eye]
Start Date: Apr/12/2012
Ongoing: NO
End Date:
UNK/UNK/2014
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802570
Page 10 of 263
***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: 11291138 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:[right iritis]
Start Date: Nov/22/2010
Ongoing: NO
End Date:
Nov/22/2010
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[viral meningitis]
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
UNK/UNK/2002
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[encephalitis]
Start Date: UNK/UNK/2002
Ongoing: NO
End Date:
UNK/UNK/2002
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diabetic neuropathy bilateral hands]
Start Date: Oct/27/2009
Ongoing: YES
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802571
Page 11 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diabetic neuropathy bilateral feet]
Start Date: Oct/27/2009
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right sided hemiplegia]
Start Date: UNK/UNK/2002
Ongoing: YES
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[asthma]
Start Date: UNK/UNK/1961
Ongoing: NO
End Date:
UNK/UNK/2016
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sleep apnea]
Start Date: UNK/UNK/2004
Ongoing: YES
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802572
Page 12 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Upper respiratory infection]
Start Date: Jan/27/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[rosacea]
Start Date: UNK/UNK/2018
Ongoing: YES
1.xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right inner thigh fungal infection]
Start Date: Sep/28/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tropical ulcer right elbow]
Start Date: Jul/15/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802573
Page 13 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.zLine/MH Number: [26]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left knee osteoarthritis]
Start Date: UNK/UNK/1998
Ongoing: YES
1.aaLine/MH Number: [27]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[unstable medial collateral ligament left knee]
Start Date: Jul/26/2017
Ongoing: YES
1.abLine/MH Number: [28]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[temporomandibular joint dysfunction]
Start Date: Jul/26/2004
Ongoing: YES
1.acLine/MH Number: [29]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[iliotibial band friction syndrome]
Start Date: UNK/UNK/2000
Ongoing: YES
1.adLine/MH Number: [30]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[spasmodic dysphonia]
Start Date: Aug/4/2003
Ongoing: YES
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802574
Page 14 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.aeLine/MH Number: [31]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[type 2 diabetes]
Start Date: UNK/UNK/2009
Ongoing: YES
1.afLine/MH Number: [32]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypercholesterolemia]
Start Date: UNK/UNK/1995
Ongoing: YES
1.agLine/MH Number: [33]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2002
Ongoing: YES
1.ahLine/MH Number: [34]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[acute lymes disease]
Start Date: Aug/8/2011
Ongoing: NO
End Date:
UNK/UNK/2011
1.aiLine/MH Number: [35]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[anxiety]
Start Date: UNK/UNK/2002
Ongoing: YES
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802575
Page 15 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ajLine/MH Number: [36]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/2002
Ongoing: YES
1.akLine/MH Number: [37]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right wrist fracture]
Start Date: UNK/UNK/1965
Ongoing: NO
End Date:
UNK/UNK/1965
1.alLine/MH Number: [38]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[jawbone cyst removal]
Start Date: UNK/UNK/1979
Ongoing: NO
End Date:
UNK/UNK/1979
1.amLine/MH Number: [39]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arthroscopy right knee]
Start Date: UNK/UNK/1985
Ongoing: NO
End Date:
UNK/UNK/1985
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802576
Page 16 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.anLine/MH Number: [40]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arthroscopy left knee]
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1993
1.aoLine/MH Number: [41]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left anterior cruciate ligament reconstruction]
Start Date: Jul/UNK/1996
Ongoing: NO
End Date:
Jul/UNK/1996
1.apLine/MH Number: [42]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[removal of bottom screw left knee]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.aqLine/MH Number: [43]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left knee repair]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802577
Page 17 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.arLine/MH Number: [44]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[arthroscopy left knee]
Start Date: Nov/21/2005
Ongoing: NO
End Date:
Nov/21/2005
1.asLine/MH Number: [45]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left total knee repair]
Start Date: May/13/2010
Ongoing: NO
End Date:
May/13/2010
1.atLine/MH Number: [46]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[revision left total knee replacement]
Start Date: Aug/15/2013
Ongoing: NO
End Date:
Aug/15/2013
1.auLine/MH Number: [47]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right radial styloid tenosynovitis surgical release]
Start Date: Apr/5/2006
Ongoing: NO
End Date:
Aug/5/2006
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802578
Page 18 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.avLine/MH Number: [48]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left radial styloid tenosynovitis release]
Start Date: Jul/20/2009
Ongoing: NO
End Date:
Jul/20/2009
1.awLine/MH Number: [49]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[revision left total knee replacement]
Start Date: Oct/10/2014
Ongoing: NO
End Date:
Oct/10/2014
1.axLine/MH Number: [50]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[laser surgery left eye]
Start Date: Nov/19/2014
Ongoing: NO
End Date:
Nov/19/2014
1.ayLine/MH Number: [51]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[iliotibial band release]
Start Date: Jul/7/2015
Ongoing: NO
End Date:
Jul/7/2015
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802579
Page 19 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.azLine/MH Number: [52]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left knee pyogenic granuloma removal]
Start Date: Nov/13/2015
Ongoing: NO
End Date:
Nov/13/2015
1.baLine/MH Number: [53]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[patella femur realignment surgery]
Start Date: Jun/14/2017
Ongoing: NO
End Date:
Jun/14/2017
1.bbLine/MH Number: [54]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lumbar laminectomy]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.bcLine/MH Number: [55]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lumbar fusion]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802580
Page 20 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.bdLine/MH Number: [56]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cataract removal left eye]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.beLine/MH Number: [57]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lesion removal right elbow]
Start Date: Jan/30/2019
Ongoing: NO
End Date:
Jan/30/2019
1.bfLine/MH Number: [58]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[revision left total knee replacement]
Start Date: Aug/20/2019
Ongoing: NO
End Date:
Aug/20/2019
1.bgLine/MH Number: [59]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[injection left iliotibial band]
Start Date: Apr/17/2020
Ongoing: NO
End Date:
Apr/17/2020
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802581
Page 21 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.bhLine/MH Number: [60]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy induced edema]
Start Date: UNK/UNK/2017
Ongoing: YES
1.biLine/MH Number: [61]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[antiphospholipid syndrome]
Start Date: UNK/UNK/2002
Ongoing: YES
1.bjLine/MH Number: [62]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gout]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802582
Page 22 of 263
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [183.2]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [27.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802583
Page 23 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [238843]
3.Randomization Group: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802584
Page 24 of 263
***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: 11291138 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/25/2020
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 [BP5PDR]
5.bSample ID [BP5PDS]
5.cSample ID [BP5PDT]
5.dSample ID [BLD10J]
5.eSample ID [BLD10K]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802585
Page 25 of 263
***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: 11291138 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/25/2020
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 [BMB57N]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802586
Page 26 of 263
***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: 11291138 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/25/2020 11:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802587
Page 27 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802588
Page 28 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802589
Page 29 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802590
Page 30 of 263
***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: 11291138 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:
Sep/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN69JY]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802591
Page 31 of 263
***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: 11291138 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: Sep/15/2020 12:02
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802592
Page 32 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802593
Page 33 of 263
***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: 11291138 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:
Oct/13/2020
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 [BN69D3]
5.bSample ID [BN69D4]
5.cSample ID [BL9RXZ]
5.dSample ID [BL9RY0]
5.eSample ID [BL9RY1]
5.fSample ID [BL9RY2]
5.gSample ID [BL9RY3]
5.hSample ID [BL9RY4]
5.iSample ID [BN69D5]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802594
Page 34 of 263
***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: 11291138 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:
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802595
Page 35 of 263
***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: 11291138 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: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802596
Page 36 of 263
***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: 11291138 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 [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802597
Page 37 of 263
***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: 11291138 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 [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802598
Page 38 of 263
***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: 11291138 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?
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802599
Page 39 of 263
***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: 11291138 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:
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802600
Page 40 of 263
***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: 11291138 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:
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802601
Page 41 of 263
***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: 11291138 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 [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802602
Page 42 of 263
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802603
Page 43 of 263
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Unplanned Assessments
1.Assessments
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802604
Page 44 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802605
Page 45 of 263
***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: 11291138 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: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802606
Page 46 of 263
***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: 11291138 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:
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802607
Page 47 of 263
***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: 11291138 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 [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802608
Page 48 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  osteomyelitis distal pha
lanx right 3rd toe Aug/31/2020
UNK:UNK NO
End Date Time:
Sep/26/2020 UNK:
UNK
 Repeating
Pages
 2. DELETED ADVERSE
EVENT 2  worsened right 3rd toe i
nfection Sep/26/2020 U
NK:UNK YES  Repeating
Pages
 3. ADVERSE
EVENT 3  detached left retina  Oct/26/2020 U
NK:UNK NO
End Date Time:
Oct/28/2020 UNK:
UNK
 Repeating
Pages
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802609
Page 49 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 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)[osteomyelitis distal phalanx right 3rd toe]
4.Start Date Time: Aug/31/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/26/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
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
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802610
Page 50 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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:
[related to bacterial infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
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[2020381758]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802611
Page 51 of 263
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[worsened right 3rd toe infection ]
4.Start Date Time: Sep/26/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
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
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802612
Page 52 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Locked, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[per investigator ]
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?:NOT RECOVERED/NOT 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[2020381758 ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802613
Page 53 of 263
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 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)[detached left retina] Comments
4.Start Date Time: Oct/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/28/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[worsening of past medical history]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802614
Page 54 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 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[ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802615
Page 55 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802616
Page 56 of 263
***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: 11291138 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[ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802617
Page 57 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.1  VACCINATIONS  NO  flu vaccine  Oct/9/20
20 Repeating
Pages
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802618
Page 58 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[flu vaccine]
5.Date: Oct/9/2020
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802619
Page 59 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802620
Page 60 of 263
***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: 11291138 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?
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802621
Page 61 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802622
Page 62 of 263
***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: 11291138 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?
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802623
Page 63 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802624
Page 64 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802625
Page 65 of 263
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802626
Page 66 of 263
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 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:
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802627
Page 67 of 263
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 11291138 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?
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802628
Page 68 of 263
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802629
Page 69 of 263
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802630
Page 70 of 263
***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: 11291138 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
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802631
Page 71 of 263
***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: 11291138 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
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802632
Page 72 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802633
Page 73 of 263
***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: 11291138 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/5/2021
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802634
Page 74 of 263
***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: 11291138 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
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802635
Page 75 of 263
***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: 11291138 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/5/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802636
Page 76 of 263
***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: 11291138 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/5/2021
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 [BRL3SM]
5.bSample ID [BRL3SN]
5.cSample ID [BRL3SP]
5.dSample ID [BLB4YY]
5.eSample ID [BLB4YZ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802637
Page 77 of 263
***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: 11291138 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/5/2021
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 [BRL3SZ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802638
Page 78 of 263
***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: 11291138 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/5/2021 11:23
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802639
Page 79 of 263
***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: 11291138 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
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802640
Page 80 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802641
Page 81 of 263
***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: 11291138 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: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802642
Page 82 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802643
Page 83 of 263
***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: 11291138 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/26/2021
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 [BRMX05]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802644
Page 84 of 263
***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: 11291138 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/26/2021 11:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802645
Page 85 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802646
Page 86 of 263
***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: 11291138 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/23/2021
3.Comments: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802647
Page 87 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802648
Page 88 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802649
Page 89 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802650
Page 90 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802651
Page 91 of 263
***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: 11291138 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/23/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802652
Page 92 of 263
***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: 11291138 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 Oct/13/2020
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802653
Page 93 of 263
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11291138 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
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802654
Page 94 of 263
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11291138 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
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802655
Page 95 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormAug-25-2020 13:12:43 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0802656
Page 96 of 263
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
3Nov-13-2020 12:45:41 (UTC-05:00) Eastern
Time (US & Canada)outpatient surgery
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0802657
Page 97 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormJan-05-2021 16:13:56 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802658
Page 98 of 263
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 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-23-2021 15:07:26 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren  Approved Jan-27-2021 22:03:18 (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 15:51:46 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren  Approved Jan-21-2021 18:14:27 (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.
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802659
Page 99 of 263
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
 N/A Jan-05-2021 16:11:45 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren  Approved Nov-16-2020 14:56:32 (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 Nov-16-2020 09:22:46 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren  Approved Nov-13-2020 13:26:35 (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 Nov-13-2020 12:45:24 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802660
Page 100 of 263
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Michael Koren  Approved Nov-12-2020 13:14:46 (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 Nov-12-2020 10:45:24 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren  Approved Nov-11-2020 10:23:42 (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 Nov-10-2020 10:48:20 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren  Approved Nov-08-2020 16:24:54 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802661
Page 101 of 263
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291138 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 Nov-06-2020 13:56:02 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren  Approved Oct-23-2020 17:40:31 (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.
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802662
Page 102 of 263
***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: 11291138 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-25-2020 13:12:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Transcription Error
Aug-25-2020 13:10:15
(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-25-2020 13:10:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802663
Page 103 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-25-2020 13:10:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/25/2020Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802664
Page 104 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-25-2020 13:09:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11291138Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-25-2020 13:08:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1953Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-25-2020 13:11:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-25-2020 13:11:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-25-2020 13:11:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802665
Page 105 of 263
***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: 11291138 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-25-2020 13:11:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802666
Page 106 of 263
***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: 11291138 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-25-2020 13:13:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-25-2020 13:13:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-25-2020 13:13:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802667
Page 107 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Aug-25-2020 13:30:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Penicillin alle
rgy
Start Date: UNK/UNK/1
958
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:30:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 13:30:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Penicillin allergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-25-2020 13:30:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1958Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-25-2020 13:30:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802668
Page 108 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b
Date Location User Value Reason
Aug-25-2020 13:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Prednisone all
ergy
Start Date: UNK/UNK/1
973
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 13:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Prednisone allergyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-25-2020 13:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1973Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-25-2020 13:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802669
Page 109 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-25-2020 13:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Kenalog aller
gy
Start Date: UNK/UNK/1
973
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 13:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Kenalog allergyInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-25-2020 13:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1973Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-25-2020 13:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802670
Page 110 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-25-2020 13:33:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Strawberry all
ergy
Start Date: UNK/UNK/1
953
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:33:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 13:33:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Strawberry allergyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-25-2020 13:33:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1953Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-25-2020 13:33:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-25-2020 13:34:07
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number 5Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802671
Page 111 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada) :
Medical History T
erm:Nut allergy
Start Date: UNK/UNK/1
975
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:34:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 13:34:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nut allergyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-25-2020 13:34:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1975Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-25-2020 13:34:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-25-2020 13:37:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:6Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802672
Page 112 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical History T
erm:steroid respo
nder
Start Date: Oct/29/2018
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:37:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 13:37:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
steroid responderInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-25-2020 13:37:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-25-2020 13:37:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-27-2020 17:00:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Norvasc alle
rgyTranscription Error
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802673
Page 113 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Date: UNK/UNK/
2017
Ongoing: YES
Aug-26-2020 10:02:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:Norvasc allergy i
nduced edema
Start Date: UNK/UNK/2017
Ongoing: YESTranscription Error
Aug-25-2020 13:40:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:Norvasc induce
d edema
Start Date: UNK/UNK/20
17
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802674
Page 114 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.g Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:40:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-28-2020
01:01:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: Clos
edDiscrepancy has
been closed.
Aug-27-2020
17:00:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Ans
weredTranscription
Error
Aug-27-2020
17:00:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Norvasc allerg
yTranscription
Error
Aug-26-2020
21:19:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: Ope
nedMultiple
concepts in the
term NORVASC
ALLERGY
INDUCED
EDEMA. Split
the term into
NORVASC
ALLERGY and
ALLERGIC
EDEMA and
submit
separately.
Thank you.
Aug-26-2020
13:04:42
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Clos
edDiscrepancy has
been closed.
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0802675
Page 115 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Eastern Time
(US & Canada)
Aug-26-2020
10:02:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredTranscription
Error
Aug-26-2020
10:02:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Norvasc allerg
y induced ede
maTranscription
Error
Aug-25-2020
18:09:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Ope
nedClarify
NORVASC
INDUCED
EDEMA as
follows...Term
is unclear. Are
you reporting
NORVASC
ALLERGY
INDUCED
EDEMA? If so,
please edit and
split into
NORVASC
ALLERGY and
ALLERGIC
EDEMA and
submit
separately.
Thank you.
Aug-25-2020
13:40:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Norvasc induc
ed edemaInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-25-2020 13:40:18
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0802676
Page 116 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
1.g Ongoing:
Date Location User Value Reason
Aug-25-2020 13:40:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-25-2020 13:42:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:seasonal aller
gies
Start Date: UNK/UNK/2
003
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802677
Page 117 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.h Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:42:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 13:42:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergiesInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-25-2020 13:42:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2003Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-25-2020 13:42:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802678
Page 118 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.i
Date Location User Value Reason
Aug-25-2020 13:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Fatty liver dis
ease
Start Date: Feb/11/2003
Ongoing: YESInitial Entry
1.i Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:44:29
(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-25-2020 13:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Fatty liver diseaseInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-25-2020 13:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/11/2003Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-25-2020 13:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802679
Page 119 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-25-2020 13:46:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:10
Medical Histor
y Term:Ocular ischemic
syndrome
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
1.j Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:46:11
(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-25-2020 13:46:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Ocular ischemic syndromeInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-25-2020 13:46:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-25-2020 13:46:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802680
Page 120 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-25-2020 13:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical History
Term:Open angle gla
ucoma
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:47:32
(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-25-2020 13:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Open angle glaucomaInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-25-2020 13:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-25-2020 13:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-25-2020 13:48:23
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802681
Page 121 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada) Line/MH Numb
er:12
Medical History
Term:left sided catara
cts
Start Date: UNK/UNK/20
18
Ongoing: NO
End Date:
UNK/UNK/
2018
1.l Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:48:23
(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-25-2020 13:48:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left sided cataractsInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-25-2020 13:48:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-25-2020 13:48:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802682
Page 122 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.m
Date Location User Value Reason
Nov-16-2020 09:22:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:13
Medical Hist
ory Term:partial detached r
etina left eye
Start Date: Apr/12/2012
Ongoing: NO
End Date:
UNK/UNK/20
14Transcription Error
Aug-25-2020 13:49:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:13
Medical Histor
y Term:partial detache
d retina
Start Date: Apr/12/2012
Ongoing: NO
End Date:
UNK/UNK/
2014Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802683
Page 123 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.m Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:49:44
(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
Nov-16-2020 09:22:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
partial detached retina left eyeTranscription Error
Aug-25-2020 13:49:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
partial detached retinaInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-25-2020 13:49:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/12/2012Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-25-2020 13:49:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.n
Date Location User Value Reason
Aug-25-2020 13:51:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:14
Medical History T
erm:right iritisInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802684
Page 124 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Date: Nov/22/2010
Ongoing: NO
End Date:
Nov/22/20
10
1.n Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:51:09
(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
Aug-25-2020 13:51:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right iritisInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-25-2020 13:51:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/22/2010Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-25-2020 13:51:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/22/2010Initial Entry
1.o
Date Location User Value Reason
Aug-31-2020 17:12:49
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
Line/MH Num 15Transcription Error
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802685
Page 125 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada) ber:
Medical Histor
y Term:viral meningiti
s
Start Date: UNK/UNK/20
02
Ongoing: NO
End Date:
UNK/UNK
/2002
Aug-25-2020 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:15
Medical Histor
y Term:meningitis
Start Date: UNK/UNK/20
02
Ongoing: NO
End Date:
UNK/UNK
/2002Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0802686
Page 126 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.o Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020 17:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
viral meningitisTranscription Error
Aug-25-2020 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
meningitisInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-25-2020 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-25-2020 13:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2002Initial Entry
1.p
Date Location User Value Reason
Aug-25-2020 13:53:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:16
Medical History
Term:encephalitisInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802687
Page 127 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Date: UNK/UNK/20
02
Ongoing: NO
End Date:
UNK/UNK/
2002
1.p Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:53:25
(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-25-2020 13:53:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
encephalitisInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-25-2020 13:53:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-25-2020 13:53:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2002Initial Entry
1.q
Date Location User Value Reason
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802688
Page 128 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-26-2020 10:36:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH N
umber:17
Medical His
tory Term:diabetic neuropat
hy bilateral hands
Start Date: Oct/27/2009
Ongoing: YESTranscription Error
Aug-25-2020 13:55:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:17
Medical His
tory Term:diabetic nephropa
thy bilateral hand
s
Start Date: Oct/27/2009
Ongoing: YESInitial Entry
1.q Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:55:33
(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-26-2020
14:06:44
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Clos
edDiscrepancy
has been
closed.
Aug-26-2020
10:36:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredTranscription
Error
Aug-26-2020
10:36:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
diabetic neuro
pathy bilateral
handsTranscription
Error
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0802689
Page 129 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020
18:09:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: O
penedClarify DIABETIC
NEPHROPATHY
BILATERAL
HANDS as
follows...Term is
unclear. Are you
reporting
DIABETIC
NEUROPATHY
BILATERAL
HANDS? Or
DIABETIC
NEPHROPATHY?
Or other? Please
edit the term to
clarify. Thank you.
Aug-25-2020
13:55:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
diabetic ne
phropathy b
ilateral han
dsInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-25-2020 13:55:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2009Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-25-2020 13:55:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.r
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0802690
Page 130 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-25-2020 13:56:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:18
Medical Hist
ory Term:diabetic neuropath
y bilateral feet
Start Date: Oct/27/2009
Ongoing: YESInitial Entry
1.r Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:56:07
(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-25-2020 13:56:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
diabetic neuropathy bilateral feetInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-25-2020 13:56:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2009Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-25-2020 13:56:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Sep-03-2020 10:32:17 ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0802691
Page 131 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00) Eastern
Time (US & Canada)Line/MH Num
ber:19
Medical Histor
y Term:right sided he
miplegia
Start Date: UNK/UNK/20
02
Ongoing: YES
Sep-03-2020 10:31:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:19
Medical History
Term:right hemipl
egia
Start Date: UNK/UNK/
2002
Ongoing: YESTranscription Error
Aug-25-2020 13:58:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:19
Medical Histor
y Term:right sided we
akness
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802692
Page 132 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.s Line/MH Number:
Date Location User Value Reason
Aug-25-2020 13:58:28
(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
Sep-04-2020 21:05:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-03-2020 10:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right sided hemiplegiaTranscription Error
Sep-03-2020 10:31:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-03-2020 10:31:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right hemiplegiaTranscription Error
Sep-02-2020 19:17:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: right
sided weakness:
Please can you
confirm if a
diagnosis is
available? Thanks
Aug-25-2020 13:58:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right sided weaknessInitial Entry
1.s Start Date:
Date Location User Value Reason
Aug-25-2020 13:58:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.s Ongoing:
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802693
Page 133 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-25-2020 13:58:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.t
Date Location User Value Reason
Aug-31-2020 17:04:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:20
Medical Histor
y Term:asthma
Start Date: UNK/UNK/19
61
Ongoing: NO
End Date:
UNK/UNK
/2016Transcription Error
Aug-25-2020 14:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:20
Medical History
Term:asthma
Start Date: UNK/UNK/
2004
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802694
Page 134 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.t Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:02:05
(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-25-2020 14:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
asthmaInitial Entry
1.t Start Date:
Date Location User Value Reason
Aug-31-2020 17:04:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1961Transcription Error
Aug-25-2020 14:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.t Ongoing:
Date Location User Value Reason
Aug-31-2020 17:04:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2016Transcription Error
Aug-25-2020 14:02:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.u
Date Location User Value Reason
Aug-25-2020 14:04:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number 21Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802695
Page 135 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
:
Medical History T
erm:sleep apnea
Start Date: UNK/UNK/2
004
Ongoing: YES
1.u Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:04:08
(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-25-2020 14:04:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
sleep apneaInitial Entry
1.u Start Date:
Date Location User Value Reason
Aug-25-2020 14:04:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.u Ongoing:
Date Location User Value Reason
Aug-25-2020 14:04:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.v
Date Location User Value Reason
Aug-25-2020 14:04:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:22Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802696
Page 136 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical Histo
ry Term:Upper respiratory
infection
Start Date: Jan/27/2015
Ongoing: NO
End Date:
UNK/UNK/20
15
1.v Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:04:48
(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-25-2020 14:04:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Upper respiratory infectionInitial Entry
1.v Start Date:
Date Location User Value Reason
Aug-25-2020 14:04:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2015Initial Entry
1.v Ongoing:
Date Location User Value Reason
Aug-25-2020 14:04:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.w
Date Location User Value Reason
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802697
Page 137 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-31-2020 17:04:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:23
Medical History
Term:rosacea
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
Aug-25-2020 14:07:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 23
Medical History Term: rosacea
Start Date:
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802698
Page 138 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.w Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:07:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23Initial Entry
1.w Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:07:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
rosaceaInitial Entry
1.w Start Date:
Date Location User Value Reason
Sep-02-2020 06:17:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-31-2020 17:04:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Aug-31-2020 17:04:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
Aug-31-2020 04:22:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The Response
for Start Date is
missing. kindly
review and update.
1.w Ongoing:
Date Location User Value Reason
Aug-25-2020 14:07:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.x
Date Location User Value Reason
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802699
Page 139 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-25-2020 14:09:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:24
Medical Hist
ory Term:right inner thigh fu
ngal infection
Start Date: Sep/28/2016
Ongoing: NO
End Date:
UNK/UNK/201
6Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802700
Page 140 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.x Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:09:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24Initial Entry
1.x Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:09:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right inner thigh fungal infectionInitial Entry
1.x Start Date:
Date Location User Value Reason
Aug-25-2020 14:09:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2016Initial Entry
1.x Ongoing:
Date Location User Value Reason
Aug-25-2020 14:09:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.y
Date Location User Value Reason
Aug-25-2020 14:09:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:25
Medical Histor
y Term:Tropical ulcer rig
ht elbow
Start Date: Jul/15/2019Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802701
Page 141 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
UNK/UNK/20
19
1.y Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:09:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25Initial Entry
1.y Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:09:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Tropical ulcer right elbowInitial Entry
1.y Start Date:
Date Location User Value Reason
Aug-25-2020 14:09:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/15/2019Initial Entry
1.y Ongoing:
Date Location User Value Reason
Aug-25-2020 14:09:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.z
Date Location User Value Reason
Aug-25-2020 14:11:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:26Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802702
Page 142 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical History
Term:left knee osteoa
rthritis
Start Date: UNK/UNK/199
8
Ongoing: YES
1.z Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:11:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26Initial Entry
1.z Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:11:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left knee osteoarthritisInitial Entry
1.z Start Date:
Date Location User Value Reason
Aug-25-2020 14:11:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.z Ongoing:
Date Location User Value Reason
Aug-25-2020 14:11:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.aa
Date Location User Value Reason
Aug-25-2020 14:12:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:27Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802703
Page 143 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical Hi
story Term
:unstable medial colla
teral ligament left kn
ee
Start Date: Jul/26/2017
Ongoing: YES
1.aa Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:12:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27Initial Entry
1.aa Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:12:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
unstable medial collateral ligame
nt left kneeInitial Entry
1.aa Start Date:
Date Location User Value Reason
Aug-25-2020 14:12:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/26/2017Initial Entry
1.aa Ongoing:
Date Location User Value Reason
Aug-25-2020 14:12:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ab
Date Location User Value Reason
Aug-25-2020 14:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:28
Medical Hist
ory Term:temporomandibular
joint dysfunctionInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802704
Page 144 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Date: Jul/26/2004
Ongoing: YES
1.ab Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28Initial Entry
1.ab Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
temporomandibular joint dysfunc
tionInitial Entry
1.ab Start Date:
Date Location User Value Reason
Aug-25-2020 14:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/26/2004Initial Entry
1.ab Ongoing:
Date Location User Value Reason
Aug-25-2020 14:16:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ac
Date Location User Value Reason
Aug-25-2020 14:17:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:29
Medical Hist
ory Term:iliotibial band frict
ion syndrome
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802705
Page 145 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ac Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:17:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29Initial Entry
1.ac Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:17:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
iliotibial band friction syndromeInitial Entry
1.ac Start Date:
Date Location User Value Reason
Aug-25-2020 14:17:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.ac Ongoing:
Date Location User Value Reason
Aug-25-2020 14:17:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ad
Date Location User Value Reason
Aug-25-2020 14:18:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:30
Medical History
Term:spasmodic dys
phonia
Start Date: Aug/4/2003
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802706
Page 146 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ad Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:18:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30Initial Entry
1.ad Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:18:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
spasmodic dysphoniaInitial Entry
1.ad Start Date:
Date Location User Value Reason
Aug-25-2020 14:18:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/4/2003Initial Entry
1.ad Ongoing:
Date Location User Value Reason
Aug-25-2020 14:18:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ae
Date Location User Value Reason
Aug-25-2020 14:18:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:31
Medical History T
erm:type 2 diabete
s
Start Date: UNK/UNK/2
009
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802707
Page 147 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ae Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:18:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31Initial Entry
1.ae Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:18:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
type 2 diabetesInitial Entry
1.ae Start Date:
Date Location User Value Reason
Aug-25-2020 14:18:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.ae Ongoing:
Date Location User Value Reason
Aug-25-2020 14:18:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.af
Date Location User Value Reason
Aug-25-2020 14:20:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:32
Medical History
Term:hypercholester
olemia
Start Date: UNK/UNK/19
95
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802708
Page 148 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.af Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:20:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32Initial Entry
1.af Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:20:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hypercholesterolemiaInitial Entry
1.af Start Date:
Date Location User Value Reason
Aug-25-2020 14:20:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.af Ongoing:
Date Location User Value Reason
Aug-25-2020 14:20:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ag
Date Location User Value Reason
Aug-25-2020 14:20:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:33
Medical History T
erm:hypertension
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802709
Page 149 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ag Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:20:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
33Initial Entry
1.ag Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:20:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hypertensionInitial Entry
1.ag Start Date:
Date Location User Value Reason
Aug-25-2020 14:20:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.ag Ongoing:
Date Location User Value Reason
Aug-25-2020 14:20:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ah
Date Location User Value Reason
Aug-31-2020 17:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:34
Medical History
Term:acute lymes di
sease
Start Date: Aug/8/2011
Ongoing: NO
End Date:
UNK/UNK/
2011Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802710
Page 150 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.ah
Date Location User Value Reason
Aug-25-2020 14:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:34
Medical History
Term:acute lymes di
sease
Start Date: Aug/8/2011
Ongoing:Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802711
Page 151 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ah Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
34Initial Entry
1.ah Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
acute lymes diseaseInitial Entry
1.ah Start Date:
Date Location User Value Reason
Aug-25-2020 14:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/8/2011Initial Entry
1.ah Ongoing:
Date Location User Value Reason
Sep-02-2020 06:17:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Aug-31-2020 17:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Initial Entry
Aug-31-2020 17:05:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
Aug-31-2020 04:25:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: The Response
for "Ongoing" is
missing. kindly
review and update.
Aug-31-2020 04:24:46
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Closed Invalid query
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0802712
Page 152 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
Aug-31-2020 04:24:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The Response
for Start Date is
missing. kindly
review and update.
1.ai
Date Location User Value Reason
Aug-25-2020 14:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:35
Medical History T
erm:anxiety
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0802713
Page 153 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ai Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35Initial Entry
1.ai Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
anxietyInitial Entry
1.ai Start Date:
Date Location User Value Reason
Aug-25-2020 14:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.ai Ongoing:
Date Location User Value Reason
Aug-25-2020 14:23:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.aj
Date Location User Value Reason
Aug-25-2020 14:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:36
Medical History T
erm:depression
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802714
Page 154 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.aj Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
36Initial Entry
1.aj Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
depressionInitial Entry
1.aj Start Date:
Date Location User Value Reason
Aug-25-2020 14:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.aj Ongoing:
Date Location User Value Reason
Aug-25-2020 14:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ak
Date Location User Value Reason
Aug-25-2020 14:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:37
Medical History
Term:right wrist fract
ure
Start Date: UNK/UNK/19
65Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802715
Page 155 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
UNK/UNK/
1965
1.ak Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
37Initial Entry
1.ak Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right wrist fractureInitial Entry
1.ak Start Date:
Date Location User Value Reason
Aug-25-2020 14:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1965Initial Entry
1.ak Ongoing:
Date Location User Value Reason
Aug-25-2020 14:27:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1965Initial Entry
1.al
Date Location User Value Reason
Aug-25-2020 14:27:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:38Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802716
Page 156 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical History
Term:jawbone cyst re
moval
Start Date: UNK/UNK/197
9
Ongoing: NO
End Date:
UNK/UNK/
1979
1.al Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:27:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
38Initial Entry
1.al Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:27:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
jawbone cyst removalInitial Entry
1.al Start Date:
Date Location User Value Reason
Aug-25-2020 14:27:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1979Initial Entry
1.al Ongoing:
Date Location User Value Reason
Aug-25-2020 14:27:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1979Initial Entry
1.am
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802717
Page 157 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-31-2020 17:16:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:39
Medical Histo
ry Term:arthroscopy rig
ht knee
Start Date: UNK/UNK/19
85
Ongoing: NO
End Date:
UNK/UNK/
1985Transcription Error
Aug-31-2020 17:13:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:39
Medical Histor
y Term:arthroscopy ri
ght knee
Start Date: UNK/UNK/19
85
Ongoing: NOInitial Entry
Aug-25-2020 14:29:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:39
Medical Histor
y Term:arthroscopy ri
ght knee
Start Date:
Ongoing: NOInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802718
Page 158 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.am Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:29:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
39Initial Entry
1.am Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:29:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
arthroscopy right kneeInitial Entry
1.am Start Date:
Date Location User Value Reason
Sep-02-2020 06:17:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-31-2020 17:13:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Aug-31-2020 17:13:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1985Initial Entry
Aug-31-2020 04:23:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The Response
for Start Date is
missing. kindly
review and update.
1.am Ongoing:
Date Location User Value Reason
Aug-31-2020 17:16:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1985Transcription Error
Aug-25-2020 14:29:03
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802719
Page 159 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada)
1.an
Date Location User Value Reason
Aug-25-2020 14:30:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:40
Medical History
Term:arthroscopy left
knee
Start Date: UNK/UNK/199
3
Ongoing: NO
End Date:
UNK/UNK/
1993Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0802720
Page 160 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.an Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:30:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
40Initial Entry
1.an Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:30:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
arthroscopy left kneeInitial Entry
1.an Start Date:
Date Location User Value Reason
Aug-25-2020 14:30:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1993Initial Entry
1.an Ongoing:
Date Location User Value Reason
Aug-25-2020 14:30:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1993Initial Entry
1.ao
Date Location User Value Reason
Aug-25-2020 14:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:41
Medical H
istory Ter
m:left anterior cruciate l
igament reconstructio
n
Start Date
:Jul/UNK/1996Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802721
Page 161 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
Jul/UNK/1996
1.ao Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
41Initial Entry
1.ao Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left anterior cruciate ligament rec
onstructionInitial Entry
1.ao Start Date:
Date Location User Value Reason
Aug-25-2020 14:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/UNK/1996Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802722
Page 162 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.ao Ongoing:
Date Location User Value Reason
Aug-25-2020 14:36:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jul/UNK/1996Initial Entry
1.ap
Date Location User Value Reason
Aug-25-2020 14:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:42
Medical Hist
ory Term:removal of bottom s
crew left knee
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/200
0Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802723
Page 163 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ap Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
42Initial Entry
1.ap Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
removal of bottom screw left kne
eInitial Entry
1.ap Start Date:
Date Location User Value Reason
Aug-25-2020 14:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.ap Ongoing:
Date Location User Value Reason
Aug-25-2020 14:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.aq
Date Location User Value Reason
Aug-25-2020 14:40:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:43
Medical History
Term:left knee repair
Start Date: UNK/UNK/200
0Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802724
Page 164 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
UNK/UNK/
2000
1.aq Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:40:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
43Initial Entry
1.aq Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:40:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left knee repairInitial Entry
1.aq Start Date:
Date Location User Value Reason
Aug-25-2020 14:40:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.aq Ongoing:
Date Location User Value Reason
Aug-25-2020 14:40:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.ar
Date Location User Value Reason
Aug-25-2020 14:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:44Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802725
Page 165 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical History
Term:arthroscopy left
knee
Start Date: Nov/21/2005
Ongoing: NO
End Date:
Nov/21/200
5
1.ar Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
44Initial Entry
1.ar Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
arthroscopy left kneeInitial Entry
1.ar Start Date:
Date Location User Value Reason
Aug-25-2020 14:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/21/2005Initial Entry
1.ar Ongoing:
Date Location User Value Reason
Aug-25-2020 14:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/21/2005Initial Entry
1.as
Date Location User Value Reason
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802726
Page 166 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-25-2020 14:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:45
Medical History
Term:left total knee r
epair
Start Date: May/13/2010
Ongoing: NO
End Date:
May/13/201
0Initial Entry
1.as Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
45Initial Entry
1.as Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left total knee repairInitial Entry
1.as Start Date:
Date Location User Value Reason
Aug-25-2020 14:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
May/13/2010Initial Entry
1.as Ongoing:
Date Location User Value Reason
Aug-25-2020 14:42:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
May/13/2010Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802727
Page 167 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.at
Date Location User Value Reason
Aug-25-2020 14:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:46
Medical Hist
ory Term:revision left total kn
ee replacement
Start Date: Aug/15/2013
Ongoing: NO
End Date:
Aug/15/2013Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802728
Page 168 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.at Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
46Initial Entry
1.at Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
revision left total knee replaceme
ntInitial Entry
1.at Start Date:
Date Location User Value Reason
Aug-25-2020 14:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/15/2013Initial Entry
1.at Ongoing:
Date Location User Value Reason
Aug-25-2020 14:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Aug/15/2013Initial Entry
1.au
Date Location User Value Reason
Aug-25-2020 14:46:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:47
Medical H
istory Ter
m:right radial styloid ten
osynovitis surgical rel
ease
Start Date
:Apr/5/2006Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802729
Page 169 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
Aug/5/2006
1.au Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:46:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
47Initial Entry
1.au Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:46:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right radial styloid tenosynovitis s
urgical releaseInitial Entry
1.au Start Date:
Date Location User Value Reason
Aug-25-2020 14:46:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/5/2006Initial Entry
1.au Ongoing:
Date Location User Value Reason
Aug-25-2020 14:46:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Aug/5/2006Initial Entry
1.av
Date Location User Value Reason
Aug-25-2020 14:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:48Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802730
Page 170 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical His
tory Term:left radial styloid ten
osynovitis release
Start Date: Jul/20/2009
Ongoing: NO
End Date:
Jul/20/2009
1.av Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
48Initial Entry
1.av Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left radial styloid tenosynovitis re
leaseInitial Entry
1.av Start Date:
Date Location User Value Reason
Aug-25-2020 14:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/20/2009Initial Entry
1.av Ongoing:
Date Location User Value Reason
Aug-25-2020 14:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jul/20/2009Initial Entry
1.aw
Date Location User Value Reason
Aug-25-2020 14:48:49 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802731
Page 171 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Nu
mber:49
Medical Hist
ory Term:revision left total kn
ee replacement
Start Date: Oct/10/2014
Ongoing: NO
End Date:
Oct/10/2014
1.aw Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:48:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
49Initial Entry
1.aw Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:48:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
revision left total knee replaceme
ntInitial Entry
1.aw Start Date:
Date Location User Value Reason
Aug-25-2020 14:48:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/10/2014Initial Entry
1.aw Ongoing:
Date Location User Value Reason
Aug-25-2020 14:48:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Oct/10/2014Initial Entry
1.ax
Date Location User Value Reason
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802732
Page 172 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-25-2020 14:51:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:50
Medical History
Term:laser surgery lef
t eye
Start Date: Nov/19/2014
Ongoing: NO
End Date:
Nov/19/201
4Initial Entry
1.ax Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:51:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
50Initial Entry
1.ax Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:51:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
laser surgery left eyeInitial Entry
1.ax Start Date:
Date Location User Value Reason
Aug-25-2020 14:51:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2014Initial Entry
1.ax Ongoing:
Date Location User Value Reason
Aug-25-2020 14:51:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/19/2014Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802733
Page 173 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ay
Date Location User Value Reason
Aug-25-2020 14:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:51
Medical History
Term:iliotibial band r
elease
Start Date: Jul/7/2015
Ongoing: NO
End Date:
Jul/7/2015Initial Entry
1.ay Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
51Initial Entry
1.ay Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
iliotibial band releaseInitial Entry
1.ay Start Date:
Date Location User Value Reason
Aug-25-2020 14:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/7/2015Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802734
Page 174 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.ay Ongoing:
Date Location User Value Reason
Aug-25-2020 14:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jul/7/2015Initial Entry
1.az
Date Location User Value Reason
Aug-31-2020 17:14:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:52
Medical Hi
story Term
:left knee pyogenic
granuloma removal
Start Date: Nov/13/2015
Ongoing: NO
End Date:
Nov/13/2015Transcription Error
Aug-25-2020 14:54:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:52
Medical Hist
ory Term:pyogenic granulo
ma removal
Start Date: Nov/13/2015
Ongoing: NO
End Date:
Nov/13/2015Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802735
Page 175 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.az Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:54:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
52Initial Entry
1.az Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-31-2020
22:11:20
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Clo
sedDiscrepancy has
been closed.
Aug-31-2020
17:14:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredTranscription
Error
Aug-31-2020
17:14:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
left knee pyo
genic granulo
ma removalTranscription
Error
Aug-25-2020
20:17:33
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Ope
nedClarify as
follows
PYOGENIC
GRANULOMA
REMOVAL.
Please specify
the site further
i.e; skin? or oral?
or other? Thank
you.
Aug-25-2020
14:54:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
pyogenic gra
nuloma remo
valInitial Entry
1.az Start Date:
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0802736
Page 176 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-25-2020 14:54:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/13/2015Initial Entry
1.az Ongoing:
Date Location User Value Reason
Aug-25-2020 14:54:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Nov/13/2015Initial Entry
1.ba
Date Location User Value Reason
Aug-25-2020 14:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:53
Medical Hist
ory Term:patella femur realig
nment surgery
Start Date: Jun/14/2017
Ongoing: NO
End Date:
Jun/14/2017Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802737
Page 177 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ba Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
53Initial Entry
1.ba Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
patella femur realignment surgeryInitial Entry
1.ba Start Date:
Date Location User Value Reason
Aug-25-2020 14:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/14/2017Initial Entry
1.ba Ongoing:
Date Location User Value Reason
Aug-25-2020 14:57:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/14/2017Initial Entry
1.bb
Date Location User Value Reason
Aug-25-2020 14:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:54
Medical History
Term:lumbar laminec
tomy
Start Date: UNK/UNK/201
8Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802738
Page 178 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
UNK/UNK/
2018
1.bb Line/MH Number:
Date Location User Value Reason
Aug-25-2020 14:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
54Initial Entry
1.bb Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 14:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
lumbar laminectomyInitial Entry
1.bb Start Date:
Date Location User Value Reason
Aug-25-2020 14:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.bb Ongoing:
Date Location User Value Reason
Aug-25-2020 14:59:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.bc
Date Location User Value Reason
Aug-25-2020 15:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:55Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802739
Page 179 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical History
Term:lumbar fusion
Start Date: UNK/UNK/201
8
Ongoing: NO
End Date:
UNK/UNK/
2018
1.bc Line/MH Number:
Date Location User Value Reason
Aug-25-2020 15:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
55Initial Entry
1.bc Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 15:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
lumbar fusionInitial Entry
1.bc Start Date:
Date Location User Value Reason
Aug-25-2020 15:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.bc Ongoing:
Date Location User Value Reason
Aug-25-2020 15:00:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.bd
Date Location User Value Reason
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802740
Page 180 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-25-2020 15:00:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:56
Medical Histor
y Term:cataract removal
left eye
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2
018Initial Entry
1.bd Line/MH Number:
Date Location User Value Reason
Aug-25-2020 15:00:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
56Initial Entry
1.bd Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 15:00:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cataract removal left eyeInitial Entry
1.bd Start Date:
Date Location User Value Reason
Aug-25-2020 15:00:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.bd Ongoing:
Date Location User Value Reason
Aug-25-2020 15:00:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802741
Page 181 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.be
Date Location User Value Reason
Aug-25-2020 15:01:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:57
Medical Histo
ry Term:lesion removal ri
ght elbow
Start Date: Jan/30/2019
Ongoing: NO
End Date:
Jan/30/2019Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802742
Page 182 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.be Line/MH Number:
Date Location User Value Reason
Aug-25-2020 15:01:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
57Initial Entry
1.be Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 15:01:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
lesion removal right elbowInitial Entry
1.be Start Date:
Date Location User Value Reason
Aug-25-2020 15:01:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/30/2019Initial Entry
1.be Ongoing:
Date Location User Value Reason
Aug-25-2020 15:01:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/30/2019Initial Entry
1.bf
Date Location User Value Reason
Aug-25-2020 15:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:58
Medical Hist
ory Term:revision left total kn
ee replacement
Start Date: Aug/20/2019Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802743
Page 183 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
Aug/20/2019
1.bf Line/MH Number:
Date Location User Value Reason
Aug-25-2020 15:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
58Initial Entry
1.bf Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 15:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
revision left total knee replaceme
ntInitial Entry
1.bf Start Date:
Date Location User Value Reason
Aug-25-2020 15:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2019Initial Entry
1.bf Ongoing:
Date Location User Value Reason
Aug-25-2020 15:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Aug/20/2019Initial Entry
1.bg
Date Location User Value Reason
Aug-25-2020 15:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:59Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802744
Page 184 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical Histo
ry Term:injection left ilioti
bial band
Start Date: Apr/17/2020
Ongoing: NO
End Date:
Apr/17/2020
1.bg Line/MH Number:
Date Location User Value Reason
Aug-25-2020 15:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
59Initial Entry
1.bg Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-25-2020 15:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
injection left iliotibial bandInitial Entry
1.bg Start Date:
Date Location User Value Reason
Aug-25-2020 15:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/17/2020Initial Entry
1.bg Ongoing:
Date Location User Value Reason
Aug-25-2020 15:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Apr/17/2020Initial Entry
1.bh
Date Location User Value Reason
Aug-27-2020 17:01:02 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802745
Page 185 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Numb
er:60
Medical History
Term:allergy induced
edema
Start Date: UNK/UNK/201
7
Ongoing: YES
1.bh Line/MH Number:
Date Location User Value Reason
Aug-27-2020 17:01:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
60Initial Entry
1.bh Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-27-2020 17:01:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
allergy induced edemaInitial Entry
1.bh Start Date:
Date Location User Value Reason
Aug-27-2020 17:01:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802746
Page 186 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.bh Ongoing:
Date Location User Value Reason
Aug-27-2020 17:01:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.bi
Date Location User Value Reason
Aug-31-2020 17:06:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:61
Medical Histor
y Term:antiphospholipid
syndrome
Start Date: UNK/UNK/2002
Ongoing: YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802747
Page 187 of 263
***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: 11291138 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.bi Line/MH Number:
Date Location User Value Reason
Aug-31-2020 17:06:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
61Initial Entry
1.bi Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-06-2020 08:33:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-03-2020 13:16:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered confirmed per query
Sep-02-2020 21:08:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
can you confirm
subject had no
thrombosis events
within 6 months as a
result of the
anti-phospholipid
syndrome? Thanks
Aug-31-2020 17:06:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
antiphospholipid syndromeInitial Entry
1.bi Start Date:
Date Location User Value Reason
Aug-31-2020 17:06:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.bi Ongoing:
Date Location User Value Reason
Aug-31-2020 17:06:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b0\Final\Final On: 01-Apr-2021 04:13 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802748
Page 188 of 263
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 For
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