125742 S1 M5 CRF c4591001 1129 11291059

Document text

Page 1 of 280
***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: 11291059 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
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801517
Page 2 of 280
***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: 11291059 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/7/2020
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801518
Page 3 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11291059]
2.Birth Date: /1943
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:
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801519
Page 4 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/7/2020
2.Erroneous Visit
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801520
Page 5 of 280
***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: 11291059 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
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801521
Page 6 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801522
Page 7 of 280
***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: 11291059 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:[levaquin allergy]
Start Date: UNK/UNK/1995
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Non-organic fruit allergy]
Start Date: UNK/UNK/1990
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Gastroesophageal reflux disease]
Start Date: UNK/UNK/1960
Ongoing: YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801523
Page 8 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Pollen Allergy]
Start Date: UNK/UNK/1960
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Colon polyps]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Enlarged Prostate]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801524
Page 9 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Erectile dysfunction]
Start Date: UNK/UNK/2013
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Low libido]
Start Date: UNK/UNK/2016
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Vitamin B12 deficiency]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801525
Page 10 of 280
***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: 11291059 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:[Bilateral Cataracts]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1999
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Myopia]
Start Date: UNK/UNK/1960
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hyperopia]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801526
Page 11 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.mLine/MH Number: [13]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Headaches]
Start Date: UNK/UNK/1960
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Left Carpal Tunnel Syndrome]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/2019
1.oLine/MH Number: [15]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Right Carpal Tunnel Syndrome]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801527
Page 12 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.pLine/MH Number: [16]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[exercise induced asthma]
Start Date: UNK/UNK/1950
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Acne]
Start Date: UNK/UNK/1960
Ongoing: NO
End Date:
UNK/UNK/1965
1.rLine/MH Number: [18]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Eczema]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801528
Page 13 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.sLine/MH Number: [19]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[basal cell carcinoma]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.tLine/MH Number: [20]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Osteoarthritis]
Start Date: Jul/UNK/2018
Ongoing: YES
1.uLine/MH Number: [21]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Type 2 Diabetes]
Start Date: UNK/UNK/1992
Ongoing: YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801529
Page 14 of 280
***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: 11291059 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:[hypercholesterolemia]
Start Date: UNK/UNK/2010
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/2000
Ongoing: YES
1.xLine/MH Number: [24]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Cardiac catheterization]
Start Date: Jan/27/2020
Ongoing: NO
End Date:
Jan/27/2020
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801530
Page 15 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.yLine/MH Number: [25]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Stent placement left anterior descending artery]
Start Date: Jan/27/2020
Ongoing: NO
End Date:
Jan/27/2020
1.zLine/MH Number: [26]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Depression]
Start Date: UNK/UNK/2005
Ongoing: YES
1.aaLine/MH Number: [27]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Insomnia]
Start Date: UNK/UNK/2005
Ongoing: YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801531
Page 16 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.abLine/MH Number: [28]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Transurethral resection of the prostate]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.acLine/MH Number: [29]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Right total knee replacement]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.adLine/MH Number: [30]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Bilateral Inguinal Hernia repair]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801532
Page 17 of 280
***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: 11291059 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:[Bilateral Cataracts surgery]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1999
1.afLine/MH Number: [32]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Tonsillectomy]
Start Date: UNK/UNK/1965
Ongoing: NO
End Date:
UNK/UNK/1965
1.agLine/MH Number: [33]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hemorrhoidectomy]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1980
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801533
Page 18 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ahLine/MH Number: [34]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hemorrhoidectomy]
Start Date: UNK/UNK/1995
Ongoing: NO
End Date:
UNK/UNK/1995
1.aiLine/MH Number: [35]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[right Shoulder reconstruction]
Start Date: UNK/UNK/1997
Ongoing: NO
End Date:
UNK/UNK/1997
1.ajLine/MH Number: [36]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Acid Reflux]
Start Date: UNK/UNK/1970
Ongoing: YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801534
Page 19 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.akLine/MH Number: [37]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[urination problems]
Start Date: UNK/UNK/2013
Ongoing: YES
1.alLine/MH Number: [38]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[right shoulder reconstruction]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.amLine/MH Number: [39]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[nocturia]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801535
Page 20 of 280
***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: 11291059 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:[tonsillitis]
Start Date: UNK/UNK/1965
Ongoing: NO
End Date:
UNK/UNK/1965
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801536
Page 21 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/7/2020
2.Weight: [160.6]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [25.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801537
Page 22 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/7/2020
2.Randomization Number: [224051]
3.Randomization Group: [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801538
Page 23 of 280
***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: 11291059 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/7/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5PWP]
5.bSample ID [BP5PWR]
5.cSample ID [BP5PWS]
5.dSample ID [BLD1FD]
5.eSample ID [BLD1FF]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801539
Page 24 of 280
***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: 11291059 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/7/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5PJL]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801540
Page 25 of 280
***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: 11291059 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/7/2020 13:45
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801541
Page 26 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801542
Page 27 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801543
Page 28 of 280
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801544
Page 29 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801545
Page 30 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801546
Page 31 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801547
Page 32 of 280
***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: 11291059 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/28/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BMB5F3]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801548
Page 33 of 280
***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: 11291059 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/28/2020 11:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801549
Page 34 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801550
Page 35 of 280
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last
day the Subject Diary was
completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801551
Page 36 of 280
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801552
Page 37 of 280
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site
reactions present on the
last day the Subject Diary
was completed?NO
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801553
Page 38 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/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 [BLD199]
5.bSample ID [BLD198]
5.cSample ID [BPC00H]
5.dSample ID [BPC00J]
5.eSample ID [BPC00K]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801554
Page 39 of 280
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L 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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801555
Page 40 of 280
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L 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: 11291059 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:
Feb/19/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSFMY8]
5.bSample ID [BSFMY9]
5.cSample ID [BTZPN3]
5.dSample ID [BTZPN4]
5.eSample ID [BTZPN5]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801556
Page 41 of 280
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801557
Page 42 of 280
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 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 [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801558
Page 43 of 280
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801559
Page 44 of 280
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 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 [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801560
Page 45 of 280
***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: 11291059 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:
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801561
Page 46 of 280
***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: 11291059 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: [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801562
Page 47 of 280
***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: 11291059 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 [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801563
Page 48 of 280
***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: 11291059 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 [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801564
Page 49 of 280
***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: 11291059 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?
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801565
Page 50 of 280
***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: 11291059 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:
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801566
Page 51 of 280
***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: 11291059 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:
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801567
Page 52 of 280
***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: 11291059 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 [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801568
Page 53 of 280
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801569
Page 54 of 280
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Unplanned Assessments
1.Assessments
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801570
Page 55 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Sep/25/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801571
Page 56 of 280
***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: 11291059 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: [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801572
Page 57 of 280
***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: 11291059 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:
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801573
Page 58 of 280
***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: 11291059 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 [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801574
Page 59 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Ev
ent Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Left supraclavicu
lar adenopathy Aug/31/2020
UNK:UNK YES  Repeating
Pages
 2.ADVERSE
EVENT 2  worsening hypert
ension Jan/1/2021 08
:00 YES  Repeating
Pages
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801575
Page 60 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 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)[Left supraclavicular adenopathy]
4.Start Date Time: Aug/31/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 1
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801576
Page 61 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801577
Page 62 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801578
Page 63 of 280
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[worsening hypertension]
4.Start Date Time: Jan/1/2021 08:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 2
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801579
Page 64 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown etiology]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801580
Page 65 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801581
Page 66 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801582
Page 67 of 280
***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: 11291059 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[ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801583
Page 68 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801584
Page 69 of 280
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801585
Page 70 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801586
Page 71 of 280
***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: 11291059 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?
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801587
Page 72 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801588
Page 73 of 280
***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: 11291059 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?
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801589
Page 74 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801590
Page 75 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801591
Page 76 of 280
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801592
Page 77 of 280
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 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:
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801593
Page 78 of 280
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 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?
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801594
Page 79 of 280
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801595
Page 80 of 280
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801596
Page 81 of 280
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801597
Page 82 of 280
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801598
Page 83 of 280
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11291059 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 [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801599
Page 84 of 280
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 11291059 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 [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801600
Page 85 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801601
Page 86 of 280
***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: 11291059 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801602
Page 87 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/17/2020
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801603
Page 88 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801604
Page 89 of 280
***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: 11291059 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: [ ]
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801605
Page 90 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/25/2020
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801606
Page 91 of 280
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 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
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801607
Page 92 of 280
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 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
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801608
Page 93 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormAug-07-2020 17:48:07 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801609
Page 94 of 280
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 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-19-2021 11:57:56 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Koren Approved Jan-21-2021 18:19:54 (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 Dec-18-2020 13:39:57 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801610
Page 95 of 280
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
N/A
Michael
Koren Approved Nov-06-2020 09:28:44 (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-05-2020 17:14:47 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Koren Approved Oct-14-2020 10:00:03 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801611
Page 96 of 280
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Sep-25-2020 13:16:14 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Koren Approved Sep-11-2020 12:16:09 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801612
Page 97 of 280
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 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.
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801613
Page 98 of 280
***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: 11291059 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-07-2020
17:46:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-07-2020
17:46:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801614
Page 99 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-07-2020
17:46:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/7/2020Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801615
Page 100 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-07-2020
17:45:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11291059Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-07-2020
17:45:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1943Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-07-2020
17:47:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801616
Page 101 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-07-2020
17:47:00
(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-07-2020
17:47:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801617
Page 102 of 280
***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: 11291059 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-07-2020
17:47:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801618
Page 103 of 280
***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: 11291059 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-07-2020
17:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-07-2020
17:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-07-2020
17:50:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801619
Page 104 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Aug-07-2020
17:51:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:levaquin
allergy
Start Date: UNK/U
NK/199
5
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-07-2020
17:51:15
(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-07-2020
17:51:15
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
levaquin allergyInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801620
Page 105 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Eastern Time (US
& Canada)
1.a Start Date:
Date Location User Value Reason
Aug-07-2020
17:51:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-07-2020
17:51:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-07-2020
17:52:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History T
erm:Non-organ
ic fruit alle
rgyInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801621
Page 106 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Date
:UNK/UN
K/1990
Ongoing: YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801622
Page 107 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b Line/MH Number:
Date Location User Value Reason
Aug-07-2020
17:52:02
(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-07-2020
17:52:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Non-organic fruit alle
rgyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-07-2020
17:52:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801623
Page 108 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-07-2020
17:52:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-13-2020
17:28:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Num
ber:3
Medical
History
Term:Gastroesop
hageal refl
ux disease
Start Da
te:UNK/UN
K/1960
Ongoing
:YESInitial Entry
Aug-07-2020
17:54:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:3
Medical
History
Term:Gastroesop
hageal refl
ux disease
Start Da
te:Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801624
Page 109 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing
:YES
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801625
Page 110 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.c Line/MH Number:
Date Location User Value Reason
Aug-07-2020
17:54:01
(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-07-2020
17:54:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Gastroesophageal refl
ux diseaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-13-2020
17:28:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1960Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801626
Page 111 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-07-2020
17:54:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-07-2020
17:54:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Pollen A
llergy
Start Date: UNK/U
NK/196
0
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801627
Page 112 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.d Line/MH Number:
Date Location User Value Reason
Aug-07-2020
17:54:30
(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-07-2020
17:54:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Pollen AllergyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-07-2020
17:54:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1960Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801628
Page 113 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-07-2020
17:54:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-07-2020
17:55:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:Colon poly
ps
Start Date
:UNK/UN
K/2018
Ongoing: NO
End Date
:
UNK/U
NK/201
8Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801629
Page 114 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.e Line/MH Number:
Date Location User Value Reason
Aug-07-2020
17:55:47
(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-07-2020
17:55:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Colon polypsInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-07-2020
17:55:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801630
Page 115 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-07-2020
17:55:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.f
Date Location User Value Reason
Aug-07-2020
17:57:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:Enlarged
Prostate
Start Date: UNK/U
NK/2013
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801631
Page 116 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.f Line/MH Number:
Date Location User Value Reason
Aug-07-2020
17:57:59
(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-07-2020
17:57:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Enlarged ProstateInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-07-2020
17:57:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.f Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801632
Page 117 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-07-2020
17:57:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-07-2020
17:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical Hi
story Term
:Erectile d
ysfunctio
n
Start Date: UNK/UN
K/2013
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801633
Page 118 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.g Line/MH Number:
Date Location User Value Reason
Aug-07-2020
17:58:37
(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-07-2020
17:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Erectile dysfunctionInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-07-2020
17:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.g Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801634
Page 119 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-07-2020
17:58:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-07-2020
17:59:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:8
Medical His
tory Term:Low libi
do
Start Date: UNK/U
NK/201
6
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801635
Page 120 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.h Line/MH Number:
Date Location User Value Reason
Aug-07-2020
17:59:19
(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-07-2020
17:59:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Low libidoInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-07-2020
17:59:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.h Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801636
Page 121 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-07-2020
17:59:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-07-2020
18:00:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical H
istory Ter
m:Vitamin B
12 deficie
ncy
Start Date
:UNK/UN
K/2010
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801637
Page 122 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.i Line/MH Number:
Date Location User Value Reason
Aug-07-2020
18:00:18
(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-07-2020
18:00:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Vitamin B12 deficien
cyInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-07-2020
18:00:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.i Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801638
Page 123 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-07-2020
18:00:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-13-2020
17:30:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:10
Medical
History T
erm:Bilateral
Cataracts
Start Dat
e:UNK/UN
K/1990
Ongoing: NO
End Dat
e:
UNK/
UNK/1
999Initial Entry
Aug-07-2020
18:01:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:10
Medical
History T
erm:Bilateral
CataractsInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801639
Page 124 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Dat
e:
Ongoing: NO
End Dat
e:
UNK/
UNK/1
999
1.j Line/MH Number:
Date Location User Value Reason
Aug-07-2020
18:01:41
(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-07-2020
18:01:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Bilateral CataractsInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801640
Page 125 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.j Start Date:
Date Location User Value Reason
Aug-13-2020
17:30:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-07-2020
18:01:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1999Initial Entry
1.k
Date Location User Value Reason
Aug-13-2020
17:30:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:11
Medical H
istory Ter
m:MyopiaInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801641
Page 126 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Date
:UNK/U
NK/196
0
Ongoing: YES
Aug-07-2020
18:03:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:11
Medical H
istory Ter
m:Myopia
Start Date
:UNK/U
NK/196
0
Ongoing:Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801642
Page 127 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.k Line/MH Number:
Date Location User Value Reason
Aug-07-2020
18:03:42
(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-07-2020
18:03:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MyopiaInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-07-2020
18:03:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1960Initial Entry
1.k Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801643
Page 128 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-13-2020
17:30:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-13-2020
17:30:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:12
Medical Hi
story Term
:Hypero
pia
Start Date: UNK/U
NK/199
0
Ongoing: YESInitial Entry
Aug-07-2020
18:04:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:12
Medical Hi
story Term
:Hypero
pia
Start Date: UNK/U
NK/199
0
Ongoing:Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801644
Page 129 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.l Line/MH Number:
Date Location User Value Reason
Aug-07-2020
18:04:15
(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-07-2020
18:04:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HyperopiaInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-07-2020
18:04:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.l Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801645
Page 130 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-13-2020
17:30:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-07-2020
18:04:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:13
Medical His
tory Term:Headach
es
Start Date: UNK/U
NK/196
0
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801646
Page 131 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.m Line/MH Number:
Date Location User Value Reason
Aug-07-2020
18:04:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020
04:08:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Katherine
LiauQuery 1: Closed recurrent
terms being
discussed
Aug-12-2020
15:19:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Katherine
LiauQuery 1: Opened Ongoing
headache is
listed with a
start year of
1960. Please
confirm if this
is considered
recurrent
headache and
update the
medical
history term as
specified in
the Case
Report Form
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0801647
Page 132 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Guidelines.
Aug-07-2020
18:04:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HeadachesInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-07-2020
18:04:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1960Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-07-2020
18:04:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-07-2020
18:06:26
(UTC-05:00)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M 14Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801648
Page 133 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Eastern Time (US
& Canada)H Numb
er:
Medical
History
Term:Left Carpal
Tunnel Synd
rome
Start Da
te:UNK/UNK/
1990
Ongoing
:NO
End Date:
UNK/UN
K/2019
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801649
Page 134 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.n Line/MH Number:
Date Location User Value Reason
Aug-07-2020
18:06:26
(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-07-2020
18:06:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Left Carpal Tunnel S
yndromeInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-07-2020
18:06:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.n Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801650
Page 135 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-07-2020
18:06:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.o
Date Location User Value Reason
Aug-07-2020
18:07:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:15
Medical
History
Term:Right Carpal
Tunnel Synd
rome
Start Da
te:UNK/UNK/
2019
Ongoing
:NO
End Date:
UNK/UN
K/2019Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801651
Page 136 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.o Line/MH Number:
Date Location User Value Reason
Aug-07-2020
18:07:01
(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-07-2020
18:07:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Right Carpal Tunnel
SyndromeInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-07-2020
18:07:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.o Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801652
Page 137 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-07-2020
18:07:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.p
Date Location User Value Reason
Aug-08-2020
10:01:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:16
Medical H
istory Ter
m:exercise in
duced asth
ma
Start Date
:UNK/UN
K/1950
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801653
Page 138 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.p Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:01:38
(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-08-2020
10:01:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
exercise induced asth
maInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-08-2020
10:01:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1950Initial Entry
1.p Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801654
Page 139 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:01:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Aug-08-2020
10:02:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:17
Medical H
istory Ter
m:Acne
Start Date
:UNK/UN
K/1960
Ongoing: NO
End Date
:
UNK/U
NK/196
5Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801655
Page 140 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.q Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:02:23
(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-08-2020
10:02:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
AcneInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-08-2020
10:02:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1960Initial Entry
1.q Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801656
Page 141 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:02:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1965Initial Entry
1.r
Date Location User Value Reason
Aug-08-2020
10:02:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:18
Medical His
tory Term:Eczema
Start Date: UNK/U
NK/201
0
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801657
Page 142 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.r Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:02:52
(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-14-2020
04:09:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Katherine
LiauQuery 1: Closed no longer
required
Aug-12-2020
14:24:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Katherine
LiauQuery 1: Opened Please update
medical
history
condition to
specify body
site/location of
eczema as
applicable.
Aug-08-2020
10:02:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
EczemaInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0801658
Page 143 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.r Start Date:
Date Location User Value Reason
Aug-08-2020
10:02:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-08-2020
10:02:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Aug-08-2020
10:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:19
Medical H
istory Ter
m:basal cell c
arcinoma
Start Date
:UNK/UN
K/2014Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801659
Page 144 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date
:
UNK/U
NK/201
4
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801660
Page 145 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.s Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020
10:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
basal cell carcinomaInitial Entry
1.s Start Date:
Date Location User Value Reason
Aug-08-2020
10:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.s Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801661
Page 146 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:03:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.t
Date Location User Value Reason
Aug-08-2020
10:04:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:20
Medical Hist
ory Term:Osteoar
thritis
Start Date: Jul/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801662
Page 147 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.t Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:04:16
(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-08-2020
10:04:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OsteoarthritisInitial Entry
1.t Start Date:
Date Location User Value Reason
Aug-08-2020
10:04:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jul/UNK/2018Initial Entry
1.t Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801663
Page 148 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:04:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.u
Date Location User Value Reason
Aug-08-2020
10:08:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:21
Medical His
tory Term:Type 2
Diabetes
Start Date: UNK/U
NK/199
2
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801664
Page 149 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.u Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:08:11
(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-08-2020
10:08:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Type 2 DiabetesInitial Entry
1.u Start Date:
Date Location User Value Reason
Aug-08-2020
10:08:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1992Initial Entry
1.u Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801665
Page 150 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:08:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.v
Date Location User Value Reason
Aug-08-2020
10:08:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:22
Medical H
istory Ter
m:hyperchol
esterolem
ia
Start Date
:UNK/UN
K/2010
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801666
Page 151 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.v Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:08:58
(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-08-2020
10:08:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
hypercholesterolemiaInitial Entry
1.v Start Date:
Date Location User Value Reason
Aug-08-2020
10:08:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.v Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801667
Page 152 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:08:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.w
Date Location User Value Reason
Aug-08-2020
10:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:23
Medical His
tory Term:Hyperte
nsion
Start Date: UNK/U
NK/200
0
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801668
Page 153 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.w Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:09:28
(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-08-2020
10:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.w Start Date:
Date Location User Value Reason
Aug-08-2020
10:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.w Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801669
Page 154 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:09:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.x
Date Location User Value Reason
Aug-08-2020
10:25:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:24
Medical
History T
erm:Cardiac cat
heterizatio
n
Start Dat
e:Jan/27/202
0
Ongoing: NO
End Date:
Jan/27/2
020Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801670
Page 155 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.x Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:25:17
(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-08-2020
10:25:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Cardiac catheterizatio
nInitial Entry
1.x Start Date:
Date Location User Value Reason
Aug-08-2020
10:25:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2020Initial Entry
1.x Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801671
Page 156 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:25:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/27/2020Initial Entry
1.y
Date Location User Value Reason
Aug-08-2020
10:27:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:25
Medic
al Hist
ory Te
rm:Stent placeme
nt left anterior
descending art
ery
Start
Date:Jan/27/2020
Ongoi
ng:NO
End Date:
Jan/27/202
0Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801672
Page 157 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.y Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:27:06
(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-08-2020
10:27:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Stent placement left a
nterior descending art
eryInitial Entry
1.y Start Date:
Date Location User Value Reason
Aug-08-2020
10:27:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2020Initial Entry
1.y Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801673
Page 158 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:27:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/27/2020Initial Entry
1.z
Date Location User Value Reason
Aug-08-2020
10:27:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:26
Medical His
tory Term:Depressi
on
Start Date: UNK/U
NK/200
5
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801674
Page 159 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.z Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:27:56
(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-08-2020
10:27:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DepressionInitial Entry
1.z Start Date:
Date Location User Value Reason
Aug-08-2020
10:27:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.z Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801675
Page 160 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:27:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.aa
Date Location User Value Reason
Aug-08-2020
10:28:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:27
Medical His
tory Term:Insomni
a
Start Date: UNK/U
NK/200
5
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801676
Page 161 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.aa Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:28:19
(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-08-2020
10:28:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
InsomniaInitial Entry
1.aa Start Date:
Date Location User Value Reason
Aug-08-2020
10:28:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.aa Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801677
Page 162 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:28:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ab
Date Location User Value Reason
Aug-08-2020
10:29:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:28
Medica
l Histor
y Term:Transurethral
resection of t
he prostate
Start D
ate:UNK/UNK/2
013
Ongoin
g:NO
End Date:
UNK/UN
K/2013Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801678
Page 163 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ab Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:29:32
(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-08-2020
10:29:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Transurethral resectio
n of the prostateInitial Entry
1.ab Start Date:
Date Location User Value Reason
Aug-08-2020
10:29:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.ab Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801679
Page 164 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:29:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.ac
Date Location User Value Reason
Aug-08-2020
10:30:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:29
Medical
History
Term:Right total k
nee replace
ment
Start Da
te:UNK/UNK/
2018
Ongoing
:NO
End Date:
UNK/UN
K/2018Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801680
Page 165 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.ac Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:30:16
(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-08-2020
10:30:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Right total knee repla
cementInitial Entry
1.ac Start Date:
Date Location User Value Reason
Aug-08-2020
10:30:16
(UTC-05:00)
Eastern Time (US
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UNK/UNK/2018Initial Entry
1.ac Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
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FDA-CBER-2021-5683-0801681
Page 166 of 280
***Confidential***
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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: 11291059 Subject Initials: ---
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Aug-08-2020
10:30:16
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Eastern Time (US
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NO
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1.ad
Date Location User Value Reason
Aug-08-2020
10:31:14
(UTC-05:00)
Eastern Time (US
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(autocalc)Data Entry:
Line/M
H Numb
er:30
Medical
History
Term:Bilateral Ing
uinal Hernia
repair
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te:UNK/UNK/
2005
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:NO
End Date:
UNK/UN
K/2005Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
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FDA-CBER-2021-5683-0801682
Page 167 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ad Line/MH Number:
Date Location User Value Reason
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10:31:14
(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-08-2020
10:31:14
(UTC-05:00)
Eastern Time (US
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Bilateral Inguinal Her
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1.ad Start Date:
Date Location User Value Reason
Aug-08-2020
10:31:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.ad Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
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(b) (4), 
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FDA-CBER-2021-5683-0801683
Page 168 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:31:14
(UTC-05:00)
Eastern Time (US
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NO
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UNK/UNK/2005Initial Entry
1.ae
Date Location User Value Reason
Aug-14-2020
09:41:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Numb
er:31
Medical
History
Term:Bilateral C
ataracts sur
gery
Start Da
te:UNK/UNK
/1990
Ongoing
:NO
End Date:
UNK/U
NK/199
9Initial Entry
Aug-08-2020
10:33:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:31
Medical
History T
erm:Bilateral
Cataracts
surgeryInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
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(b) (4), 
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(b) (4)
FDA-CBER-2021-5683-0801684
Page 169 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Dat
e:
Ongoing:
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801685
Page 170 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ae Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:33:15
(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-08-2020
10:33:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Bilateral Cataracts su
rgeryInitial Entry
1.ae Start Date:
Date Location User Value Reason
Aug-14-2020
09:41:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.ae Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801686
Page 171 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-14-2020
09:41:47
(UTC-05:00)
Eastern Time (US
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NO
End Date:
UNK/UNK/1999Initial Entry
1.af
Date Location User Value Reason
Aug-19-2020
16:17:21
(UTC-05:00)
Eastern Time (US
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Line/M
H Numb
er:32
Medical
History
Term:Tonsillect
omy
Start Da
te:UNK/UN
K/1965
Ongoing
:NO
End Dat
e:
UNK/
UNK/
1965Transcription
Error
Aug-08-2020
10:33:44
(UTC-05:00)
Eastern Time (US
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(autocalc)Data Entry:
Line/MH
Number:32
Medical Hi
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:Tonsill
ectomyInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801687
Page 172 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Date:
Ongoing:
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(b) (4)
FDA-CBER-2021-5683-0801688
Page 173 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.af Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:33:44
(UTC-05:00)
Eastern Time (US
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(autocalc)Data Entry:
32Initial Entry
1.af Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020
10:33:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
TonsillectomyInitial Entry
1.af Start Date:
Date Location User Value Reason
Aug-19-2020
16:17:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1965Transcription
Error
1.af Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801689
Page 174 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-19-2020
16:17:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1965Transcription
Error
1.ag
Date Location User Value Reason
Aug-08-2020
10:34:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:33
Medical H
istory Ter
m:Hemorrhoi
dectomy
Start Date
:UNK/UN
K/1980
Ongoing: NO
End Date
:
UNK/U
NK/198
0Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801690
Page 175 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ag Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:34:31
(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-08-2020
10:34:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HemorrhoidectomyInitial Entry
1.ag Start Date:
Date Location User Value Reason
Aug-08-2020
10:34:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.ag Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
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(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801691
Page 176 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:34:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1980Initial Entry
1.ah
Date Location User Value Reason
Aug-08-2020
10:34:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:34
Medical H
istory Ter
m:Hemorrhoi
dectomy
Start Date
:UNK/UN
K/1995
Ongoing: NO
End Date
:
UNK/U
NK/199
5Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801692
Page 177 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ah Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:34:58
(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-08-2020
10:34:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HemorrhoidectomyInitial Entry
1.ah Start Date:
Date Location User Value Reason
Aug-08-2020
10:34:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.ah Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801693
Page 178 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:34:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1995Initial Entry
1.ai
Date Location User Value Reason
Aug-14-2020
09:44:20
(UTC-05:00)
Eastern Time (US
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Line/M
H Num
ber:35
Medica
l Histor
y Term
:right Shoul
der reconst
ruction
Start D
ate:UNK/UN
K/1997
Ongoin
g:NO
End Date
:
UNK/U
NK/199
7Transcription
Error
Aug-08-2020
10:40:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:35Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801694
Page 179 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medical H
istory Ter
m:Should
er Surg
ery
Start Date
:
Ongoing:
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801695
Page 180 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ai Line/MH Number:
Date Location User Value Reason
Aug-08-2020
10:40:20
(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-14-2020
09:44:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
right Shoulder recon
structionTranscription
Error
Aug-08-2020
10:40:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Shoulder SurgeryInitial Entry
1.ai Start Date:
Date Location User Value Reason
Aug-14-2020
09:44:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1997Transcription
Error
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801696
Page 181 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ai Ongoing:
Date Location User Value Reason
Aug-14-2020
09:44:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1997Transcription
Error
1.aj
Date Location User Value Reason
Aug-13-2020
17:28:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:36
Medical His
tory Term:Acid Ref
lux
Start Date: UNK/U
NK/197
0
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801697
Page 182 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.aj Line/MH Number:
Date Location User Value Reason
Aug-13-2020
17:28:18
(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-13-2020
17:28:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Acid RefluxInitial Entry
1.aj Start Date:
Date Location User Value Reason
Aug-13-2020
17:28:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1970Initial Entry
1.aj Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801698
Page 183 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-13-2020
17:28:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ak
Date Location User Value Reason
Aug-13-2020
17:30:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:37
Medical Hi
story Term
:urination
problems
Start Date: UNK/UN
K/2013
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801699
Page 184 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.ak Line/MH Number:
Date Location User Value Reason
Aug-13-2020
17:30:16
(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-13-2020
17:30:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
urination problemsInitial Entry
1.ak Start Date:
Date Location User Value Reason
Aug-13-2020
17:30:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.ak Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801700
Page 185 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-13-2020
17:30:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.al
Date Location User Value Reason
Aug-14-2020
09:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:38
Medical
History
Term:right should
er reconstru
ction
Start Da
te:UNK/UNK/
2005
Ongoing
:NO
End Date:
UNK/UN
K/2005Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801701
Page 186 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.al Line/MH Number:
Date Location User Value Reason
Aug-14-2020
09:44:46
(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-14-2020
09:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
right shoulder reconst
ructionInitial Entry
1.al Start Date:
Date Location User Value Reason
Aug-14-2020
09:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.al Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801702
Page 187 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-14-2020
09:44:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.am
Date Location User Value Reason
Aug-19-2020
16:18:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:39
Medical His
tory Term:nocturia
Start Date: UNK/U
NK/201
3
Ongoing: YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801703
Page 188 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.am Line/MH Number:
Date Location User Value Reason
Aug-19-2020
16:18:23
(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-19-2020
16:18:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
nocturiaInitial Entry
1.am Start Date:
Date Location User Value Reason
Aug-19-2020
16:18:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.am Ongoing:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801704
Page 189 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-19-2020
16:18:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.an
Date Location User Value Reason
Aug-19-2020
16:24:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Line/M
H Numb
er:40
Medical
History
Term:tonsillitis
Start Da
te:UNK/UN
K/1965
Ongoing
:NO
End Dat
e:
UNK/
UNK/
1965Transcription
Error
Aug-19-2020
16:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/
MH N
umber
:40Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801705
Page 190 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Medic
al Hist
ory Te
rm:Transurethr
al resection
of the prost
ate
Start
Date:UNK/UNK/
2013
Ongoi
ng:NO
End Date:
UNK/U
NK/201
3
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801706
Page 191 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.an Line/MH Number:
Date Location User Value Reason
Aug-19-2020
16:22:37
(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-19-2020
16:24:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
tonsillitisTranscription
Error
Aug-19-2020
16:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Transurethral resecti
on of the prostateInitial Entry
1.an Start Date:
Date Location User Value Reason
Aug-19-2020
16:24:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1965Transcription
Error
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801707
Page 192 of 280
***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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-19-2020
16:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.an Ongoing:
Date Location User Value Reason
Aug-19-2020
16:24:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1965Transcription
Error
Aug-19-2020
16:22:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801708
Page 193 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Aug-08-2020
10:41:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-08-2020
10:41:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
160.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-08-2020
10:41:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801709
Page 194 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-08-2020
10:41:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-08-2020
10:41:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-08-2020
10:41:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.2Initial Entry
7.a
Date Location User Value Reason
Aug-08-2020
10:41:18
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Record Ide 1Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801710
Page 195 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Eastern Time (US
& Canada)ntifier::
Temperatu
re:97.6
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-08-2020
10:41:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-08-2020
10:41:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801711
Page 196 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:41:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-08-2020
10:41:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801712
Page 197 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-08-2020
10:41:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-08-2020
10:41:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
224051Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801713
Page 198 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-07-2020
17:57:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-07-2020
17:57:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-07-2020
17:57:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/7/2020Transcription
Error
Aug-07-2020 ACV0PFEINFP6000  auto query Query 2: Closed Close Auto
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801714
Page 199 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
17:57:15
(UTC-05:00)
Eastern Time (US
& Canada)(autoquery) Query
Aug-07-2020
17:57:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Aug-07-2020
17:57:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription
Error
Aug-07-2020
17:57:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to
"Sample
Collected?" is
No, but
Barcodes are
present on the
page.
Aug-07-2020
17:57:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Sample
Collected?' is
marked as No
and 'If no
sample was
collected or
sample was not
collected
according to
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801715
Page 200 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
protocol,
please provide
reason' is
missing. Please
review and
update as
appropriate.
Aug-07-2020
17:57:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Aug-07-2020
17:55:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP5PW
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-07-2020
17:55:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5PWPInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801716
Page 201 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.b
Date Location User Value Reason
Aug-07-2020
17:55:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP5PW
RInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-07-2020
17:55:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5PWRInitial Entry
5.c
Date Location User Value Reason
Aug-07-2020
17:56:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BP5PW
SInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801717
Page 202 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.c Sample ID
Date Location User Value Reason
Aug-07-2020
17:56:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5PWSInitial Entry
5.d
Date Location User Value Reason
Aug-07-2020
17:56:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BLD1F
DInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-07-2020
17:56:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLD1FDInitial Entry
5.e
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801718
Page 203 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-07-2020
17:56:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BLD1F
FInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-07-2020
17:56:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLD1FFInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801719
Page 204 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-07-2020
17:59:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-07-2020
17:59:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-07-2020
17:59:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801720
Page 205 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-07-2020
17:58:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP5PJ
LInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-07-2020
17:58:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP5PJLInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801721
Page 206 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-08-2020
10:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-08-2020
10:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-08-2020
10:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801722
Page 207 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-08-2020
10:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020 13:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-08-2020
10:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-08-2020
10:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-08-2020
10:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801723
Page 208 of 280
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-08-2020
10:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-08-2020
10:42:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801724
Page 209 of 280
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-08-2020
10:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801725
Page 210 of 280
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 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-28-2020
14:38:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801726
Page 211 of 280
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801727
Page 212 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801728
Page 213 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.b Symptom:
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801729
Page 214 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NO
2.c Symptom:
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-28-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0801730
Page 215 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: C
HI
L
LS
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
O
2.d Symptom:
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801731
Page 216 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NOInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801732
Page 217 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.e Symptom:
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EAInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801733
Page 218 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
O
2.f Symptom:
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-28-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0801734
Page 219 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever o
r systemic sy
mptoms pre
sent on the l
ast day the S
ubject Diary
was complet
ed?:NO
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801735
Page 220 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.g Symptom:
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
NInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801736
Page 221 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.h Symptom:
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801737
Page 222 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
OInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801738
Page 223 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::SW
EL
LI
NGInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801739
Page 224 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020
14:39:11ACV0PFEINFP6000  Data Entry:
Injection Site PAIInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801740
Page 225 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical
Research
Subject No: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00)
Eastern Time (US
& Canada)Reaction:: N AT
INJE
CTI
ON
SITE
Were injectio
n site reaction
s present on t
he last day th
e Subject Dia
ry was compl
eted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020
14:39:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801741
Page 226 of 280
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
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: 11291059 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020
14:39:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2.a
Date Location User Value Reason
Aug-28-2020
14:39:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.3
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-28-2020
14:39:28
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae30b6\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0801742
Page 227 of 280
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
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: 11291059 Subject Initials: ---
Generated By: Generated Time (
…[truncated]