Document text
Page 1 of 189
***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: 11291095 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
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802004
Page 2 of 189
***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: 11291095 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/11/2020
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802005
Page 3 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11291095]
2.Birth Date: /1952
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802006
Page 4 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802007
Page 5 of 189
***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: 11291095 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
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802008
Page 6 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802009
Page 7 of 189
***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: 11291095 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:[allergy:aspirin]
Start Date: UNK/UNK/2009
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/1980
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[acid reflux]
Start Date: UNK/UNK/1980
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[irritable bowel syndrome]
Start Date: UNK/UNK/1975
Ongoing: YES
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802010
Page 8 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[constipation]
Start Date: UNK/UNK/1975
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[diarrhea]
Start Date: UNK/UNK/1975
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[urinary frequency]
Start Date: UNK/UNK/2008
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[low libido]
Start Date: UNK/UNK/1984
Ongoing: YES
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802011
Page 9 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tonsillitis]
Start Date: UNK/UNK/1953
Ongoing: NO
End Date:
UNK/UNK/1953
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sciatica]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2019
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[sleep apnea]
Start Date: UNK/UNK/1980
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802012
Page 10 of 189
***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: 11291095 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:[osteoporosis]
Start Date: UNK/UNK/2009
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[scoliosis]
Start Date: UNK/UNK/1985
Ongoing: YES
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[overweight]
Start Date: UNK/UNK/1989
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[depression]
Start Date: UNK/UNK/1995
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[insomnia]
Start Date: UNK/UNK/1970
Ongoing: YES
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802013
Page 11 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gastric bypass]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tonsillectomy]
Start Date: UNK/UNK/1953
Ongoing: NO
End Date:
UNK/UNK/1953
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[bladder tuck-retrocele repair]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hysterectomy]
Start Date: UNK/UNK/1984
Ongoing: NO
End Date:
UNK/UNK/1984
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802014
Page 12 of 189
***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: 11291095 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:[tummy tuck]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[reduction mammoplasty]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[multiple basal cell carcinoma]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
Jun/UNK/2020
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[basal cell carcinoma mohs surgery]
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
UNK/UNK/2020
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802015
Page 13 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.zLine/MH Number: [26]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[face lift]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.aaLine/MH Number: [27]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[knee pain-left]
Start Date: Jun/UNK/2020
Ongoing: YES
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802016
Page 14 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [198.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [31.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802017
Page 15 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/11/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802018
Page 16 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [225696]
3.Randomization Group: [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802019
Page 17 of 189
***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: 11291095 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/11/2020
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 [BP5PGS]
5.bSample ID [BP5PGT]
5.cSample ID [BP5PGV]
5.dSample ID [BLD0RZ]
5.eSample ID [BLD0S0]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802020
Page 18 of 189
***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: 11291095 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/11/2020
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 [BN6954]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802021
Page 19 of 189
***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: 11291095 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/11/2020 12:24
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802022
Page 20 of 189
***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: 11291095 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
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802023
Page 21 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802024
Page 22 of 189
***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: 11291095 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
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
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802025
Page 23 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
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
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802026
Page 24 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802027
Page 25 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/31/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802028
Page 26 of 189
***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: 11291095 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/31/2020
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 [BMB5FG]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802029
Page 27 of 189
***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: 11291095 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/31/2020 11:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802030
Page 28 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802031
Page 29 of 189
***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: 11291095 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
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
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802032
Page 30 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
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
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802033
Page 31 of 189
***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: 11291095 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/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 [BLD116]
5.bSample ID [BLD117]
5.cSample ID [BPC03S]
5.dSample ID [BPC03T]
5.eSample ID [BPC03V]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802034
Page 32 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802035
Page 33 of 189
***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: 11291095 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/22/2021
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 [BTZPP2]
5.bSample ID [BTZPP3]
5.cSample ID [BTZPP4]
5.dSample ID [BSFMYD]
5.eSample ID [BSFMYF]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802036
Page 34 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802037
Page 35 of 189
***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: 11291095 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 [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802038
Page 36 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802039
Page 37 of 189
***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: 11291095 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 [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802040
Page 38 of 189
***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: 11291095 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:
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802041
Page 39 of 189
***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: 11291095 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: [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802042
Page 40 of 189
***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: 11291095 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 [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802043
Page 41 of 189
***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: 11291095 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 [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802044
Page 42 of 189
***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: 11291095 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?
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802045
Page 43 of 189
***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: 11291095 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:
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802046
Page 44 of 189
***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: 11291095 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:
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802047
Page 45 of 189
***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: 11291095 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 [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802048
Page 46 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802049
Page 47 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Unplanned Assessments
1.Assessments
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802050
Page 48 of 189
***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: 11291095 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/28/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802051
Page 49 of 189
***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: 11291095 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: [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802052
Page 50 of 189
***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: 11291095 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:
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802053
Page 51 of 189
***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: 11291095 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 [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802054
Page 52 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 worsened left knee degener
ative joint disease Oct/5/2020 U
NK:UNK NO
End Date Time:
Oct/6/2020 UNK:U
NK
Repeating
Pages
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802055
Page 53 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 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)[worsened left knee degenerative joint disease]
4.Start Date Time: Oct/5/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/6/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802056
Page 54 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[osteoarthritis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021201150]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802057
Page 55 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
1. Repeating
Pages
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802058
Page 56 of 189
***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: 11291095 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[ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802059
Page 57 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802060
Page 58 of 189
***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: 11291095 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: //
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802061
Page 59 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802062
Page 60 of 189
***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: 11291095 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?
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802063
Page 61 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802064
Page 62 of 189
***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: 11291095 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?
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802065
Page 63 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802066
Page 64 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802067
Page 65 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802068
Page 66 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 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:
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802069
Page 67 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802070
Page 68 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 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?
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802071
Page 69 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802072
Page 70 of 189
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802073
Page 71 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802074
Page 72 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802075
Page 73 of 189
***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: 11291095 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 [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802076
Page 74 of 189
***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: 11291095 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 [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802077
Page 75 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802078
Page 76 of 189
***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: 11291095 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
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802079
Page 77 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802080
Page 78 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802081
Page 79 of 189
***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: 11291095 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: [ ]
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802082
Page 80 of 189
***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: 11291095 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/28/2020
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802083
Page 81 of 189
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 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
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802084
Page 82 of 189
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 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
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802085
Page 83 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormAug-11-2020 17:53:10 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802086
Page 84 of 189
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 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-24-2021 15:16:11 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Jan-21-2021 17:51:59 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Jan-07-2021 10:39:09 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Oct-14-2020 10:15:04 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802087
Page 85 of 189
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 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-28-2020 09:28:26 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Sep-11-2020 12:28:50 (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.
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802088
Page 86 of 189
***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: 11291095 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-11-2020 17:52:30
(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-11-2020 17:52:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802089
Page 87 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-11-2020 17:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Aug/11/2020Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802090
Page 88 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-11-2020 17:52:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11291095Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-11-2020 17:52:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1952Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-11-2020 17:52:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-11-2020 17:52:53
(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-11-2020 17:52:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802091
Page 89 of 189
***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: 11291095 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-11-2020 17:53:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802092
Page 90 of 189
***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: 11291095 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-11-2020 17:53:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-11-2020 17:53:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-11-2020 17:53:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802093
Page 91 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Aug-11-2020 17:55:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:allergy:aspir
in
Start Date: UNK/UNK/
2009
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-11-2020 17:55:44
(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-11-2020 17:55:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
allergy:aspirinInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-11-2020 17:55:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-11-2020 17:55:44 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30b4\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-2021-5683-0802094
Page 92 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00) Eastern
Time (US & Canada)YES
1.b
Date Location User Value Reason
Aug-11-2020 17:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:GERD
Start Date: UNK/UNK/
1980
Ongoing: YESInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802095
Page 93 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b Line/MH Number:
Date Location User Value Reason
Aug-11-2020 17:56:15
(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-11-2020 17:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GERDInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-11-2020 17:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-11-2020 17:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-11-2020 17:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:acid reflux
Start Date: UNK/UNK/
1980
Ongoing: YESInitial Entry
090177e196ae30b4\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-2021-5683-0802096
Page 94 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.c Line/MH Number:
Date Location User Value Reason
Aug-11-2020 17:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 17:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
acid refluxInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-11-2020 17:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-11-2020 17:56:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-11-2020 17:57:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:irritable bowel
syndrome
Start Date: UNK/UNK/19
75
Ongoing: YESInitial Entry
090177e196ae30b4\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-2021-5683-0802097
Page 95 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.d Line/MH Number:
Date Location User Value Reason
Aug-11-2020 17:57:16
(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-11-2020 17:57:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
irritable bowel syndromeInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-11-2020 17:57:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1975Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-11-2020 17:57:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-11-2020 17:57:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:constipation
Start Date: UNK/UNK/
1975
Ongoing: YESInitial Entry
090177e196ae30b4\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-2021-5683-0802098
Page 96 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.e Line/MH Number:
Date Location User Value Reason
Aug-11-2020 17:57:38
(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-11-2020 17:57:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
constipationInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-11-2020 17:57:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1975Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-11-2020 17:57:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-11-2020 17:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:diarrhea
Start Date: UNK/UNK/
1975
Ongoing: YESInitial Entry
090177e196ae30b4\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-2021-5683-0802099
Page 97 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.f Line/MH Number:
Date Location User Value Reason
Aug-11-2020 17:57:54
(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-11-2020 17:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
diarrheaInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-11-2020 17:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1975Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-11-2020 17:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-11-2020 17:58:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:urinary frequ
ency
Start Date: UNK/UNK/
2008
Ongoing: YESInitial Entry
090177e196ae30b4\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-2021-5683-0802100
Page 98 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.g Line/MH Number:
Date Location User Value Reason
Aug-11-2020 17:58:25
(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-11-2020 17:58:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
urinary frequencyInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-11-2020 17:58:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-11-2020 17:58:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-11-2020 17:58:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:low libido
Start Date: UNK/UNK/
1984
Ongoing: YESInitial Entry
090177e196ae30b4\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-2021-5683-0802101
Page 99 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.h Line/MH Number:
Date Location User Value Reason
Aug-11-2020 17:58:58
(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-11-2020 17:58:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
low libidoInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-11-2020 17:58:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1984Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-11-2020 17:58:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-11-2020 18:00:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histor
y Term:tonsillitis
Start Date: UNK/UNK/19
53Initial Entry
090177e196ae30b4\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-2021-5683-0802102
Page 100 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
UNK/UNK
/1953
1.i Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:00:19
(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-11-2020 18:00:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
tonsillitisInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-11-2020 18:00:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1953Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-11-2020 18:00:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1953Initial Entry
1.j
Date Location User Value Reason
Aug-11-2020 18:00:48 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae30b4\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-2021-5683-0802103
Page 101 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Num
ber:10
Medical Histor
y Term:sciatica
Start Date: UNK/UNK/20
10
Ongoing: NO
End Date:
UNK/UNK
/2019
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802104
Page 102 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.j Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:00:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 18:00:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
sciaticaInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-11-2020 18:00:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-11-2020 18:00:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
090177e196ae30b4\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-2021-5683-0802105
Page 103 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.k
Date Location User Value Reason
Aug-11-2020 18:01:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:11
Medical History
Term:sleep apnea
Start Date: UNK/UNK/
1980
Ongoing: YESInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802106
Page 104 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.k Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:01:15
(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-11-2020 18:01:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
sleep apneaInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-11-2020 18:01:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-11-2020 18:01:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-11-2020 18:02:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:12
Medical History
Term:osteoarthriti
s
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
090177e196ae30b4\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-2021-5683-0802107
Page 105 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.l Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:02:50
(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-11-2020 18:02:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
osteoarthritisInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-11-2020 18:02:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-11-2020 18:02:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-11-2020 18:03:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:13
Medical History
Term:osteoporosis
Start Date: UNK/UNK/
2009
Ongoing: YESInitial Entry
090177e196ae30b4\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-2021-5683-0802108
Page 106 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.m Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:03:16
(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-11-2020 18:03:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
osteoporosisInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-11-2020 18:03:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-11-2020 18:03:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-11-2020 18:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:14
Medical History
Term:scoliosis
Start Date: UNK/UNK/
1985
Ongoing: YESInitial Entry
090177e196ae30b4\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-2021-5683-0802109
Page 107 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.n Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:03:38
(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-11-2020 18:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
scoliosisInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-11-2020 18:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1985Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-11-2020 18:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Aug-11-2020 18:04:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:15
Medical History
Term:overweight
Start Date: UNK/UNK/
1989
Ongoing: YESInitial Entry
090177e196ae30b4\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-2021-5683-0802110
Page 108 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.o Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:04:04
(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-11-2020 18:04:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
overweightInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-11-2020 18:04:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1989Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-11-2020 18:04:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Aug-11-2020 18:04:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:16
Medical History
Term:depression
Start Date: UNK/UNK/
1995
Ongoing: YESInitial Entry
090177e196ae30b4\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-2021-5683-0802111
Page 109 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.p Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:04:31
(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-11-2020 18:04:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
depressionInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-11-2020 18:04:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-11-2020 18:04:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Aug-11-2020 18:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:17
Medical History
Term:insomnia
Start Date: UNK/UNK/
1970
Ongoing: YESInitial Entry
090177e196ae30b4\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-2021-5683-0802112
Page 110 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.q Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:04:50
(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-11-2020 18:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
insomniaInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-11-2020 18:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1970Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-11-2020 18:04:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
Aug-11-2020 18:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:18
Medical Histor
y Term:gastric bypass
Start Date: UNK/UNK/20
09Initial Entry
090177e196ae30b4\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-2021-5683-0802113
Page 111 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
UNK/UNK
/2009
1.r Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:06:19
(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-11-2020 18:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
gastric bypassInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-11-2020 18:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2009Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-11-2020 18:06:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.s
Date Location User Value Reason
090177e196ae30b4\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-2021-5683-0802114
Page 112 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-11-2020 18:07:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:19
Medical Histor
y Term:tonsillectomy
Start Date: UNK/UNK/19
53
Ongoing: NO
End Date:
UNK/UNK
/1953Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802115
Page 113 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.s Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:07:38
(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-11-2020 18:07:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
tonsillectomyInitial Entry
1.s Start Date:
Date Location User Value Reason
Aug-11-2020 18:07:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1953Initial Entry
1.s Ongoing:
Date Location User Value Reason
Aug-11-2020 18:07:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1953Initial Entry
1.t
Date Location User Value Reason
Aug-12-2020 10:10:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH N
umber:20
Medical His
tory Term:bladder tuck-ret
rocele repair
Start Date: UNK/UNK/200
7Transcription Error
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802116
Page 114 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
UNK/UNK/
2007
Aug-11-2020 18:08:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:20
Medical Hist
ory Term:bladder tuck-r
etrocele
Start Date: UNK/UNK/2
007
Ongoing: NO
End Date:
UNK/UN
K/2007Initial Entry
1.t Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:08:10
(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-12-2020
15:59:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery 1: C
losedDiscrepancy
has been
closed.
Aug-12-2020
10:10:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: A
nsweredTranscription
Error
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0802117
Page 115 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Aug-12-2020
10:10:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
bladd
er tuc
k-retr
ocele
repairTranscription Error
Aug-12-2020
06:10:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
OracleQuery
1: Op
enedClarify BLADDER
TUCK-RETROCELE
as follows...Are you
reporting BLADDER
TUCK-RECTOCELE
REPAIR? If so,
update the verbatim
term as such.
Otherwise clarify and
edit the term. Thank
you.
Aug-11-2020
18:08:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
bladd
er tuc
k-retr
oceleInitial Entry
1.t Start Date:
Date Location User Value Reason
Aug-11-2020 18:08:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2007Initial Entry
1.t Ongoing:
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0802118
Page 116 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-11-2020 18:08:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.u
Date Location User Value Reason
Aug-11-2020 18:08:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:21
Medical Histor
y Term:hysterectomy
Start Date: UNK/UNK/19
84
Ongoing: NO
End Date:
UNK/UNK
/1984Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802119
Page 117 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.u Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:08:41
(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-11-2020 18:08:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
hysterectomyInitial Entry
1.u Start Date:
Date Location User Value Reason
Aug-11-2020 18:08:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1984Initial Entry
1.u Ongoing:
Date Location User Value Reason
Aug-11-2020 18:08:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1984Initial Entry
1.v
Date Location User Value Reason
Aug-12-2020 10:20:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:22
Medical Histor
y Term:tummy tuck
Start Date: UNK/UNK/20
13Initial Entry
090177e196ae30b4\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-2021-5683-0802120
Page 118 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
UNK/UNK
/2013
1.v Line/MH Number:
Date Location User Value Reason
Aug-12-2020 10:20:31
(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-12-2020 10:20:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
tummy tuckInitial Entry
1.v Start Date:
Date Location User Value Reason
Aug-12-2020 10:20:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2013Initial Entry
1.v Ongoing:
Date Location User Value Reason
Aug-12-2020 10:20:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.w
Date Location User Value Reason
Aug-12-2020 10:22:58 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae30b4\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-2021-5683-0802121
Page 119 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Nu
mber:23
Medical Histo
ry Term:reduction mam
moplasty
Start Date: UNK/UNK/201
2
Ongoing: NO
End Date:
UNK/UNK/
2012
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802122
Page 120 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.w Line/MH Number:
Date Location User Value Reason
Aug-12-2020 10:22:58
(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-12-2020 10:22:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
reduction mammoplastyInitial Entry
1.w Start Date:
Date Location User Value Reason
Aug-12-2020 10:22:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.w Ongoing:
Date Location User Value Reason
Aug-12-2020 10:22:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.x
Date Location User Value Reason
Aug-12-2020 16:50:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:24
Medical Hist
ory Term:multiple basal cel
l carcinoma
Start Date: UNK/UNK/2000Initial Entry
090177e196ae30b4\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-2021-5683-0802123
Page 121 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
Jun/UNK/202
0
1.x Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:50:54
(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-12-2020 16:50:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
multiple basal cell carcinomaInitial Entry
1.x Start Date:
Date Location User Value Reason
Aug-12-2020 16:50:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.x Ongoing:
Date Location User Value Reason
Aug-12-2020 16:50:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/UNK/2020Initial Entry
1.y
Date Location User Value Reason
Aug-12-2020 16:52:09 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae30b4\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-2021-5683-0802124
Page 122 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH N
umber:25
Medical His
tory Term:basal cell carcino
ma mohs surgery
Start Date: Jun/UNK/2020
Ongoing: NO
End Date:
UNK/UNK/20
20
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802125
Page 123 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.y Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:52:09
(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-19-2020 22:18:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Aug-18-2020 10:10:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered inclusion criterion
#3 met per
investigator and
coordinator
Aug-16-2020 02:58:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened basal cell
carcinoma mohs
surgery: Please
can you confirm
subject meets
inclusion criterion
3 as a result of the
start date of this
medhx? Thanks
Aug-12-2020 16:52:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
basal cell carcinoma mohs sur
geryInitial Entry
1.y Start Date:
Date Location User Value Reason
Aug-12-2020 16:52:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2020Initial Entry
1.y Ongoing:
Date Location User Value Reason
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802126
Page 124 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-12-2020 16:52:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2020Initial Entry
1.z
Date Location User Value Reason
Aug-19-2020 10:12:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:26
Medical Histor
y Term:face lift
Start Date: UNK/UNK/20
15
Ongoing: NO
End Date:
UNK/UNK
/2015Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802127
Page 125 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.z Line/MH Number:
Date Location User Value Reason
Aug-19-2020 10:12:45
(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-19-2020 10:12:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
face liftInitial Entry
1.z Start Date:
Date Location User Value Reason
Aug-19-2020 10:12:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.z Ongoing:
Date Location User Value Reason
Aug-19-2020 10:12:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.aa
Date Location User Value Reason
Aug-19-2020 16:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:27
Medical History T
erm:knee pain-l
eft
Start Date: Jun/UNK/2
020Initial Entry
090177e196ae30b4\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-2021-5683-0802128
Page 126 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: YES
1.aa Line/MH Number:
Date Location User Value Reason
Aug-19-2020 16:42:50
(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-19-2020 16:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
knee pain-leftInitial Entry
1.aa Start Date:
Date Location User Value Reason
Aug-19-2020 16:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/UNK/2020Initial Entry
1.aa Ongoing:
Date Location User Value Reason
Aug-19-2020 16:42:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30b4\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-2021-5683-0802129
Page 127 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Aug-11-2020 17:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-11-2020 17:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
198.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-11-2020 17:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-11-2020 17:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-11-2020 17:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802130
Page 128 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-11-2020 17:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
31.0Initial Entry
7.a
Date Location User Value Reason
Aug-11-2020 17:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 97.8
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-11-2020 17:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-11-2020 17:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-11-2020 17:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802131
Page 129 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-11-2020 17:54:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802132
Page 130 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-11-2020 17:54:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-11-2020 17:54:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-11-2020 17:54:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-11-2020 17:54:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-11-2020 17:54:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802133
Page 131 of 189
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-11-2020 17:54:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-11-2020 17:54:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-11-2020 17:54:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-11-2020 17:54:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802134
Page 132 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-11-2020 17:54:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-11-2020 17:54:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
225696Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802135
Page 133 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020 18:09:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020 18:09:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-11-2020 18:10:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-11-2020 18:09:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-11-2020 18:09:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802136
Page 134 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-11-2020 18:10:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5PGSInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-11-2020 18:10:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5PGSInitial Entry
5.b
Date Location User Value Reason
Aug-11-2020 18:10:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5PGTInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-11-2020 18:10:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5PGTInitial Entry
5.c
Date Location User Value Reason
Aug-11-2020 18:10:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5PGVInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-11-2020 18:10:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5PGVInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802137
Page 135 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.d
Date Location User Value Reason
Aug-11-2020 18:10:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLD0RZInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-11-2020 18:10:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLD0RZInitial Entry
5.e
Date Location User Value Reason
Aug-11-2020 18:10:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLD0S0Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-11-2020 18:10:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLD0S0Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802138
Page 136 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020 18:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020 18:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-11-2020 18:12:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-11-2020 18:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-11-2020 18:12:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802139
Page 137 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-11-2020 18:12:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BN6954Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-11-2020 18:12:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BN6954Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802140
Page 138 of 189
***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: 11291095 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-11-2020 17:55:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-11-2020 17:55:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-11-2020 17:55:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-11-2020 17:55:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020 12:24Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-11-2020 17:55:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802141
Page 139 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-11-2020 17:55:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-11-2020 17:55:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-11-2020 17:55:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-11-2020 17:55:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802142
Page 140 of 189
***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: 11291095 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-11-2020 17:55:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802143
Page 141 of 189
***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: 11291095 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-31-2020 13:09:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802144
Page 142 of 189
***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: 11291095 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-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-31-2020 13:10:51
(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-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802145
Page 143 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Aug-31-2020 13:10:51
(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-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802146
Page 144 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.c Symptom:
Date Location User Value Reason
Aug-31-2020 13:10:51
(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-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-31-2020 13:10:51
(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-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802147
Page 145 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.e
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-31-2020 13:10:51
(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-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802148
Page 146 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.f Symptom:
Date Location User Value Reason
Aug-31-2020 13:10:51
(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-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WORS
ENED M
USCLE P
AIN
Were fever or syst
emic symptoms pr
esent on the last da
y the Subject Diar
y was completed?:NOInitial Entry
090177e196ae30b4\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-2021-5683-0802149
Page 147 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.g Symptom:
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUS
CLE 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-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae30b4\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-2021-5683-0802150
Page 148 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.h Symptom:
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOIN
T 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-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-31-2020 13:10:51
(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-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:
:RE
DN
ES
SInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802151
Page 149 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020 13:10:51
(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-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::SW
ELL
ING
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:NOInitial Entry
090177e196ae30b4\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-2021-5683-0802152
Page 150 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020 13:10:51
(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-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reacti
on::PAIN
AT INJ
ECTIO
N SITE
Were injection site r
eactions present on t
he last day the Subje
ct Diary was comple
ted?:NOInitial Entry
090177e196ae30b4\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-2021-5683-0802153
Page 151 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 13:10:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802154
Page 152 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 13:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
2.a
Date Location User Value Reason
Aug-31-2020 13:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifie
r::1
Temperature: 97.9
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 13:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-31-2020 13:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-31-2020 13:11:17 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0802155
Page 153 of 189
***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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00) Eastern
Time (US & Canada)F
2.a Temperature Location:
Date Location User Value Reason
Aug-31-2020 13:11:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802156
Page 154 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-31-2020 13:11:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-31-2020 13:11:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-31-2020 13:11:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-31-2020 13:11:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-31-2020 13:11:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802157
Page 155 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-31-2020 13:11:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-31-2020 13:11:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-31-2020 13:11:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-31-2020 13:11:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT DONEInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802158
Page 156 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 18:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 18:10:03
(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-31-2020 18:10:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-31-2020 18:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 18:10:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802159
Page 157 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-31-2020 18:10:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMB5FGInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-31-2020 18:10:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMB5FGInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802160
Page 158 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 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-31-2020 13:12:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 13:12:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 13:12:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 13:12:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/31/2020 11:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 13:12:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802161
Page 159 of 189
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-31-2020 13:12:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-31-2020 13:12:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020 13:12:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-31-2020 13:12:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802162
Page 160 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-28-2020 09:28:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/28/2020Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802163
Page 161 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11291095 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
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-28-2020 09:34:53
(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
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802164
Page 162 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Sep-28-2020 09:34:53
(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
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802165
Page 163 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.c Symptom:
Date Location User Value Reason
Sep-28-2020 09:34:53
(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
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-28-2020 09:34:53
(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
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802166
Page 164 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.e
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom: VO
MIT
ING
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-28-2020 09:34:53
(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
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802167
Page 165 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.f Symptom:
Date Location User Value Reason
Sep-28-2020 09:34:53
(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
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WORS
ENED M
USCLE
PAIN
Were fever or syst
emic symptoms pr
esent on the last da
y the Subject Diar
y was completed?:NOInitial Entry
090177e196ae30b4\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-2021-5683-0802168
Page 166 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.g Symptom:
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUS
CLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae30b4\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-2021-5683-0802169
Page 167 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.h Symptom:
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOIN
T PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-28-2020 09:34:53
(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
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:
:RE
DN
ES
SInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802170
Page 168 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Were injection site reac
tions present on the last
day the Subject Diary w
as completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-28-2020 09:34:53
(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
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::SW
ELL
ING
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:NOInitial Entry
090177e196ae30b4\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-2021-5683-0802171
Page 169 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-28-2020 09:34:53
(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
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reacti
on::PAIN
AT INJ
ECTIO
N SITE
Were injection site r
eactions present on t
he last day the Subje
ct Diary was comple
ted?:NOInitial Entry
090177e196ae30b4\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-2021-5683-0802172
Page 170 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-28-2020 09:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802173
Page 171 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 13:42:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 13:42:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 13:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 13:42:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-29-2020 13:42:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802174
Page 172 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Sep-29-2020 13:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLD116Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 13:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLD116Initial Entry
5.b
Date Location User Value Reason
Sep-29-2020 13:43:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLD117Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-29-2020 13:43:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLD117Initial Entry
5.c
Date Location User Value Reason
Sep-29-2020 13:43:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPC03SInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-29-2020 13:43:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPC03SInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802175
Page 173 of 189
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.d
Date Location User Value Reason
Sep-29-2020 13:43:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPC03TInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-29-2020 13:43:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPC03TInitial Entry
5.e
Date Location User Value Reason
Sep-29-2020 13:44:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPC03VInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-29-2020 13:44:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPC03VInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802176
Page 174 of 189
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 11:35:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/22/2021Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802177
Page 175 of 189
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-24-2021 15:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-24-2021 15:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-24-2021 15:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-24-2021 15:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-24-2021 15:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/22/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802178
Page 176 of 189
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Feb-24-2021 15:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BTZPP2Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-24-2021 15:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BTZPP2Initial Entry
5.b
Date Location User Value Reason
Feb-24-2021 15:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BTZPP3Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-24-2021 15:16:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BTZPP3Initial Entry
5.c
Date Location User Value Reason
Feb-24-2021 15:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BTZPP4Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-24-2021 15:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BTZPP4Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802179
Page 177 of 189
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.d
Date Location User Value Reason
Feb-24-2021 15:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSFMYDInitial Entry
5.d Sample ID
Date Location User Value Reason
Feb-24-2021 15:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSFMYDInitial Entry
5.e
Date Location User Value Reason
Feb-24-2021 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSFMYFInitial Entry
5.e Sample ID
Date Location User Value Reason
Feb-24-2021 15:17:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSFMYFInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802180
Page 178 of 189
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 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
Sep-28-2020 10:40:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-28-2020 10:40:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-28-2020 10:40:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802181
Page 179 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802182
Page 180 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Category:
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
worsened left knee degenerativ
e joint diseaseInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/6/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae30b4\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-2021-5683-0802183
Page 181 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-03-2021 04:45:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE worsened
left knee
degenerative joint
disease: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event requir
e or prolong hospitalization?Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802184
Page 182 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life thre
atening?
NO
Other medically important se
rious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
osteoarthritisInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802185
Page 183 of 189
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-02-2021 11:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-03-2021 04:45:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021201150Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802186
Page 184 of 189
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-07-2021 10:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/30/2020Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802187
Page 185 of 189
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-07-2021 10:41:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-07-2021 10:40:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-07-2021 10:40:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802188
Page 186 of 189
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-07-2021 10:41:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/5/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-07-2021 10:41:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATIO
NInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802189
Page 187 of 189
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-28-2020 10:40:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-11-2020 17:54:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-11-2020 17:53:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-02-2021
14:15:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Mar-02-2021
11:40:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per query
Feb-26-2021
04:21:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2021201476
worsened left knee
degenerative joint disease
(DJD)was reported as
serious in Safety database
but missing in AE CRF.
Please confirm and update
CRF. If safety update is
required, submit a
follow-up SAE Form.
Sep-28-2020 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae30b4\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-2021-5683-0802190
Page 188 of 189
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
10:40:44
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Sep/28/2020
Aug-11-2020
17:54:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/11/2020Initial Entry
Aug-11-2020
17:53:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/11/2020Initial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4)
FDA-CBER-2021-5683-0802191
Page 189 of 189
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
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: 11291095 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-11-2020 12:23:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae30b4\Final\Final On: 01-Apr-2021 04:14 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0802192