Document text
Page 1 of 190
***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: 11291045 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
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801026
Page 2 of 190
***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: 11291045 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/4/2020
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801027
Page 3 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Demography
1.Subject ID [11291045]
2.Birth Date: /1966
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801028
Page 4 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/4/2020
2.Erroneous Visit
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801029
Page 5 of 190
***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: 11291045 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
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801030
Page 6 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801031
Page 7 of 190
***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: 11291045 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 Contrast Dye]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Diverticulosis]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Erectile Dysfunction]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy Pollen]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801032
Page 8 of 190
***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: 11291045 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:[Vitamin D Deficiency]
Start Date: UNK/UNK/2017
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Farsighted]
Start Date: UNK/UNK/2016
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Shoulder Melanoma]
Start Date: Apr/4/2018
Ongoing: NO
End Date:
Apr/4/2018
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[High Cholesterol]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801033
Page 9 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2015
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Herpes Simplex]
Start Date: UNK/UNK/2000
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2010
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Anxiety]
Start Date: UNK/UNK/2010
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801034
Page 10 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Attention Deficit Hyperactivity Disorder]
Start Date: UNK/UNK/2010
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hernia Repair]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hernia]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
Apr/UNK/2017
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801035
Page 11 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/4/2020
2.Weight: [184.4]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [26.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801036
Page 12 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/4/2020
2.Randomization Number: [42102]
3.Randomization Group: [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801037
Page 13 of 190
***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: 11291045 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/4/2020
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 [BP5PX4]
5.bSample ID [BP5PX5]
5.cSample ID [BP5PX6]
5.dSample ID [BLD1DX]
5.eSample ID [BLD1DY]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801038
Page 14 of 190
***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: 11291045 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/4/2020
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 [BP5R0X]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801039
Page 15 of 190
***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: 11291045 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/4/2020 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
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801040
Page 16 of 190
***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: 11291045 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
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801041
Page 17 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801042
Page 18 of 190
***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: 11291045 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
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801043
Page 19 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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?YES
Ongoing?
NO
Stop Date:
Aug/12/2020
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
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801044
Page 20 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801045
Page 21 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BMB570]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801046
Page 22 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/25/2020 11:23
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
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801047
Page 23 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801048
Page 24 of 190
***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: 11291045 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
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801049
Page 25 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
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
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801050
Page 26 of 190
***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: 11291045 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/22/2020
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 [BPC009]
5.bSample ID [BPC00B]
5.cSample ID [BPC00C]
5.dSample ID [BLD1C9]
5.eSample ID [BLD1CB]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801051
Page 27 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801052
Page 28 of 190
***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: 11291045 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/16/2021
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 [BTZPJ6]
5.bSample ID [BTZPJ7]
5.cSample ID [BTZPJ8]
5.dSample ID [BSFMX5]
5.eSample ID [BSFMX6]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801053
Page 29 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801054
Page 30 of 190
***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: 11291045 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 [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801055
Page 31 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801056
Page 32 of 190
***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: 11291045 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 [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801057
Page 33 of 190
***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: 11291045 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:
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801058
Page 34 of 190
***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: 11291045 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: [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801059
Page 35 of 190
***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: 11291045 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 [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801060
Page 36 of 190
***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: 11291045 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 [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801061
Page 37 of 190
***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: 11291045 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?
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801062
Page 38 of 190
***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: 11291045 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:
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801063
Page 39 of 190
***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: 11291045 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:
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801064
Page 40 of 190
***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: 11291045 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 [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801065
Page 41 of 190
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/26/2020Form: 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801066
Page 42 of 190
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/26/2020Form: UNPLANNED VISIT
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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801067
Page 43 of 190
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/26/2020Form: CONTACT OUTCOME - UNPLANNED
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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/26/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801068
Page 44 of 190
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/27/2020Form: 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/27/2020
2.Erroneous Visit
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801069
Page 45 of 190
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/27/2020Form: UNPLANNED VISIT
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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801070
Page 46 of 190
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/27/2020Form: CONTACT OUTCOME - UNPLANNED
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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/27/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801071
Page 47 of 190
***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: 11291045 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/22/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801072
Page 48 of 190
***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: 11291045 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: [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801073
Page 49 of 190
***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: 11291045 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:
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801074
Page 50 of 190
***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: 11291045 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 [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801075
Page 51 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 compound fracture le
ft wrist Jan/31/2021 UNK:
UNK YES Repeating
Pages
2.ADVERSE EV
ENT 2 fall Jan/31/2021 UNK:
UNK NO
End Date Time:
Jan/31/2021 UNK:UNK
Repeating
Pages
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801076
Page 52 of 190
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 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)[compound fracture left wrist]
4.Start Date Time: Jan/31/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[patient fell playing tennis]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801077
Page 53 of 190
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2021168659]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801078
Page 54 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[fall]
4.Start Date Time: Jan/31/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/31/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[tripped]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801079
Page 55 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED WITH SEQUELAE
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801080
Page 56 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801081
Page 57 of 190
***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: 11291045 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[ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801082
Page 58 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801083
Page 59 of 190
***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: 11291045 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: //
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801084
Page 60 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801085
Page 61 of 190
***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: 11291045 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?
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801086
Page 62 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801087
Page 63 of 190
***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: 11291045 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?
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801088
Page 64 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801089
Page 65 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801090
Page 66 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801091
Page 67 of 190
***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: 11291045 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:
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801092
Page 68 of 190
***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: 11291045 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?
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801093
Page 69 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801094
Page 70 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801095
Page 71 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801096
Page 72 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801097
Page 73 of 190
***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: 11291045 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 [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801098
Page 74 of 190
***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: 11291045 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 [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801099
Page 75 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801100
Page 76 of 190
***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
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
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 1/2Comments
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801101
Page 77 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/16/2021 Comments
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION Comments
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801102
Page 78 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801103
Page 79 of 190
***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: 11291045 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: [ ]
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801104
Page 80 of 190
***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: 11291045 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/22/2020
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801105
Page 81 of 190
***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: 11291045 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
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801106
Page 82 of 190
***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: 11291045 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
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801107
Page 83 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormAug-06-2020 07:02:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
Not Applicable
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801108
Page 84 of 190
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - Comments
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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormDec-28-2020 13:21:30 (UTC-05:00) Eastern
Time (US & Canada)visit entered in error
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801109
Page 85 of 190
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormMar-01-2021 12:39:09 (UTC-05:00) Eastern
Time (US & Canada)
FormFeb-24-2021 12:33:17 (UTC-05:00) Eastern
Time (US & Canada)Not Done
FormFeb-16-2021 14:36:45 (UTC-05:00) Eastern
Time (US & Canada)
FormDec-29-2020 09:39:06 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801110
Page 86 of 190
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact Form: FURTHER VACCINATION CONFIRMATION - Comments
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
1Mar-01-2021 12:39:09 (UTC-05:00) Eastern
Time (US & Canada)
1Feb-24-2021 12:33:17 (UTC-05:00) Eastern
Time (US & Canada)Not Done
1Feb-16-2021 14:36:45 (UTC-05:00) Eastern
Time (US & Canada)
1Dec-29-2020 09:39:06 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0801111
Page 87 of 190
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
FormFeb-16-2021 14:37:43 (UTC-05:00) Eastern
Time (US & Canada)
FormDec-30-2020 10:59:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801112
Page 88 of 190
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
1Feb-16-2021 14:37:43 (UTC-05:00) Eastern
Time (US & Canada)
1Dec-30-2020 10:59:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0801113
Page 89 of 190
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
ItemDate User Comment
2Feb-16-2021 14:37:43 (UTC-05:00) Eastern
Time (US & Canada)
2Dec-30-2020 10:59:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0801114
Page 90 of 190
***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: 11291045 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-16-2021 14:32:31 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Jan-21-2021 18:08:49 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Dec-18-2020 15:53:15 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Oct-14-2020 09:53:56 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelKoren, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801115
Page 91 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
N/A Sep-22-2020 10:34:21 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Koren Approved Sep-11-2020 12:11:04 (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.
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801116
Page 92 of 190
***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: 11291045 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-04-2020 14:25:33
(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-04-2020 14:25:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801117
Page 93 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-04-2020 14:25:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/4/2020Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801118
Page 94 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-04-2020 14:24:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11291045Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-04-2020 14:24:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1966Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-04-2020 14:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-04-2020 14:26:36
(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-04-2020 14:26:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801119
Page 95 of 190
***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: 11291045 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-04-2020 14:27:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801120
Page 96 of 190
***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: 11291045 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-04-2020 14:27:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-04-2020 14:27:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-04-2020 14:27:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801121
Page 97 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.a
Date Location User Value Reason
Aug-04-2020 14:29:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Allergy Contras
t Dye
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:29:08
(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-04-2020 14:29:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergy Contrast DyeInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-04-2020 14:29:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-04-2020 14:29:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801122
Page 98 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b
Date Location User Value Reason
Aug-04-2020 14:30:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Diverticulosis
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/
2017Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801123
Page 99 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.b Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:30:54
(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-04-2020 14:30:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DiverticulosisInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-04-2020 14:30:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-04-2020 14:30:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.c
Date Location User Value Reason
Aug-04-2020 14:31:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Erectile Dysfun
ction
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801124
Page 100 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.c Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:31:50
(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-04-2020 14:31:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Erectile DysfunctionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-04-2020 14:31:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-04-2020 14:31:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-04-2020 14:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History T
erm:Allergy Polle
n
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801125
Page 101 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.d Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:32:16
(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-04-2020 14:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Allergy PollenInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-04-2020 14:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-04-2020 14:32:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-04-2020 14:33:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Vitamin D Defi
ciency
Start Date: UNK/UNK/201
7
Ongoing: YESInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801126
Page 102 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.e Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:33:51
(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-04-2020 14:33:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Vitamin D DeficiencyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-04-2020 14:33:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-04-2020 14:33:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-04-2020 14:35:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History T
erm:Farsighted
Start Date: UNK/UNK/2
016
Ongoing: YESInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801127
Page 103 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.f Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:35:19
(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-04-2020 14:35:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FarsightedInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-04-2020 14:35:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-04-2020 14:35:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-04-2020 14:35:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Asthma
Start Date: UNK/UNK/201
2
Ongoing: NO
End Date:
UNK/UNK/
2012Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801128
Page 104 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.g Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:35:51
(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-04-2020 14:35:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AsthmaInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-04-2020 14:35:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2012Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-04-2020 14:35:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.h
Date Location User Value Reason
Aug-04-2020 14:37:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:Left Shoulder Me
lanoma
Start Date: Apr/4/2018
Ongoing: NO
End Date:
Apr/4/2018Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801129
Page 105 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.h Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:37:10
(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-04-2020 14:37:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Left Shoulder MelanomaInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-04-2020 14:37:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Apr/4/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-04-2020 14:37:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/4/2018Initial Entry
1.i
Date Location User Value Reason
Aug-04-2020 14:37:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History T
erm:High Choleste
rol
Start Date: UNK/UNK/2
017
Ongoing: YESInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801130
Page 106 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.i Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:37:57
(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-04-2020 14:37:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
High CholesterolInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-04-2020 14:37:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-04-2020 14:37:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-04-2020 14:38:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801131
Page 107 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.j Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:38:24
(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-04-2020 14:38:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-04-2020 14:38:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2015Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-04-2020 14:38:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801132
Page 108 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1.k
Date Location User Value Reason
Aug-04-2020 14:39:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History T
erm:Herpes Simpl
ex
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:39:33
(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-04-2020 14:39:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Herpes SimplexInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-04-2020 14:39:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-04-2020 14:39:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801133
Page 109 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-04-2020 14:40:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 12
Medical History T
erm:Depression
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
1.l Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:40:27
(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-04-2020 14:40:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
DepressionInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-04-2020 14:40:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-04-2020 14:40:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-04-2020 14:41:03
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801134
Page 110 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Time (US & Canada) Line/MH Number: 13
Medical History T
erm:Anxiety
Start Date: UNK/UNK/2
010
Ongoing: YES
1.m Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:41:03
(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-04-2020 14:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AnxietyInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-04-2020 14:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-04-2020 14:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-04-2020 14:41:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 14
Medical History T
erm:InsomniaInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801135
Page 111 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Start Date: UNK/UNK/2
010
Ongoing: YES
1.n Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:41:31
(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-04-2020 14:41:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
InsomniaInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-04-2020 14:41:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-04-2020 14:41:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Aug-04-2020 14:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:15
Medical His
tory Term:Attention Deficit Hy
peractivity Disorder
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801136
Page 112 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.o Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-04-2020 14:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Attention Deficit Hyperactivity
DisorderInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-04-2020 14:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-04-2020 14:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Aug-04-2020 14:43:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:16
Medical History
Term:Hernia Repair
Start Date: UNK/UNK/201
7
Ongoing: NO
End Date:
UNK/UNK/
2017Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801137
Page 113 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
1.p Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:43:00
(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-04-2020 14:43:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Hernia RepairInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-04-2020 14:43:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-04-2020 14:43:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.q
Date Location User Value Reason
Aug-04-2020 14:50:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:17
Medical Histor
y Term:Hernia
Start Date: UNK/UNK/2
017Transcription Error
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801138
Page 114 of 190
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Ongoing: NO
End Date:
Apr/UNK/
2017
Aug-04-2020 14:43:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 17
Medical History Term
:Herni
a
Start Date:
Ongoing:Initial Entry
1.q Line/MH Number:
Date Location User Value Reason
Aug-04-2020 14:43:39
(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-04-2020 14:43:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HerniaInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-04-2020 14:50:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Transcription Error
1.q Ongoing:
Date Location User Value Reason
Aug-04-2020 14:50:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Apr/UNK/2017Transcription Error
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801139
Page 115 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Aug-04-2020 14:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-04-2020 14:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
184.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-04-2020 14:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-04-2020 14:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
70.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-04-2020 14:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-04-2020 14:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
26.5Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801140
Page 116 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7.a
Date Location User Value Reason
Aug-04-2020 14:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:
:1
Temperature: 99.0
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-04-2020 14:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-04-2020 14:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
99.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-04-2020 14:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-04-2020 14:45:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801141
Page 117 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-04-2020 14:46:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-04-2020 14:46:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
42102Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801142
Page 118 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-04-2020 14:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-04-2020 14:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-04-2020 14:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-04-2020 14:47:07
(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-04-2020 14:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/4/2020Initial Entry
5.a
Date Location User Value Reason
Aug-04-2020 14:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5PX4Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801143
Page 119 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Aug-04-2020 14:59:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5PX4Initial Entry
5.b
Date Location User Value Reason
Aug-04-2020 14:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5PX5Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-04-2020 14:59:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5PX5Initial Entry
5.c
Date Location User Value Reason
Aug-04-2020 14:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5PX6Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-04-2020 14:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5PX6Initial Entry
5.d
Date Location User Value Reason
Aug-04-2020 15:00:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLD1DXInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801144
Page 120 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.d Sample ID
Date Location User Value Reason
Aug-04-2020 15:00:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLD1DXInitial Entry
5.e
Date Location User Value Reason
Aug-04-2020 15:00:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLD1DYInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-04-2020 15:00:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLD1DYInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801145
Page 121 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-04-2020 14:47:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-04-2020 14:47:28
(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-04-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-04-2020 14:47:28
(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-04-2020 14:47:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/4/2020Initial Entry
5.a
Date Location User Value Reason
Aug-04-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP5R0XInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801146
Page 122 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Aug-04-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP5R0XInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801147
Page 123 of 190
***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: 11291045 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-04-2020 14:48:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-04-2020 14:48:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-04-2020 14:48:42
(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-04-2020 14:48:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/4/2020 11:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-04-2020 14:48:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-04-2020 14:48:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801148
Page 124 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
7. Route:
Date Location User Value Reason
Aug-04-2020 14:48:42
(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-04-2020 14:48:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-04-2020 14:48:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801149
Page 125 of 190
***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: 11291045 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-04-2020 14:49:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGENICITY E-D
IARY COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801150
Page 126 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-25-2020 12:50:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801151
Page 127 of 190
***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: 11291045 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-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-25-2020 12:54:17
(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-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIG
UEInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801152
Page 128 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NO
2.b Symptom:
Date Location User Value Reason
Aug-25-2020 12:54:17
(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-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801153
Page 129 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.c Symptom:
Date Location User Value Reason
Aug-25-2020 12:54:17
(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-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-25-2020 12:54:17
(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-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801154
Page 130 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-25-2020 12:54:17
(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-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801155
Page 131 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.f Symptom:
Date Location User Value Reason
Aug-25-2020 12:54:17
(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-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-25-2020 15:10:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801156
Page 132 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.g Symptom:
Date Location User Value Reason
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 15:10:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801157
Page 133 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
3. Injection Site Location:
Date Location User Value Reason
Aug-25-2020 12:54:17
(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-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-26-2020 14:33:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reacti
on::REDNES
S
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:YES
Ongoing
?
NO
Stop
Date:
Aug
/12/
202
0Transcription Error
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:YE
SInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801158
Page 134 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-25-2020 12:54:17
(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-26-2020 14:33:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/12/2020Transcription Error
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
5.b
Date Location User Value Reason
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801159
Page 135 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-25-2020 12:54:17
(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-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-25-2020 12:54:17
(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-25-2020 12:54:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801160
Page 136 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date:
Date Location User Value Reason
Aug-25-2020 12:55:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/25/2020Initial Entry
2.a
Date Location User Value Reason
Aug-25-2020 12:55:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.1
Temperature Unit: F
Temperature Loca
tion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-25-2020 12:55:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-25-2020 12:55:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.1Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-25-2020 12:55:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801161
Page 137 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Aug-25-2020 12:55:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801162
Page 138 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-27-2020 10:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-27-2020 10:57:49
(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-27-2020 10:58:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 10:57:49
(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-27-2020 10:57:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-27-2020 10:58:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BMB570Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801163
Page 139 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Aug-27-2020 10:58:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BMB570Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801164
Page 140 of 190
***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: 11291045 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-25-2020 12:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-25-2020 12:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-25-2020 12:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-09-2020
02:25:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Close
dPer site
confirmation
Sep-08-2020
11:42:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query 1
: Answ
eredChanged data per
query
Sep-07-2020
07:23:27
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD Query 1
: Opene
dPDQ: Subject has
reported with
Severe
symptoms/reactions
on '2020-08-27'.
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0801165
Page 141 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Canada) Per protocol,
subjects
experiencing Grade
3 local reactions
should be
contacted. Please
confirm if an
UNPLANNED
CONTACT was
made and update
the corresponding
form as appropriate.
Aug-25-2020
12:56:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data E
ntry:
Aug/25/
2020 11
:23Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-25-2020 12:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-25-2020 12:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-25-2020 12:56:22
(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
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0801166
Page 142 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Aug-25-2020 12:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-25-2020 12:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801167
Page 143 of 190
***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: 11291045 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-22-2020 10:34:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801168
Page 144 of 190
***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: 11291045 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-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-22-2020 10:35:15
(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-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TIG
UEInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801169
Page 145 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-22-2020 10:35:15
(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-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801170
Page 146 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.c Symptom:
Date Location User Value Reason
Sep-22-2020 10:35:15
(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-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-22-2020 10:35:15
(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-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801171
Page 147 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-22-2020 10:35:15
(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-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801172
Page 148 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.f Symptom:
Date Location User Value Reason
Sep-22-2020 10:35:15
(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-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801173
Page 149 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
2.h
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-22-2020 10:35:15
(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-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801174
Page 150 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-22-2020 10:35:15
(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-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801175
Page 151 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-22-2020 10:35:15
(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-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-22-2020 10:35:15
(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-22-2020 10:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801176
Page 152 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-23-2020 16:20:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-23-2020 16:20:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-23-2020 16:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 16:20:11
(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.
Sep-23-2020 16:20:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-23-2020 16:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPC009Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801177
Page 153 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Sep-23-2020 16:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPC009Initial Entry
5.b
Date Location User Value Reason
Sep-23-2020 16:20:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPC00BInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-23-2020 16:20:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPC00BInitial Entry
5.c
Date Location User Value Reason
Sep-23-2020 16:20:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPC00CInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-23-2020 16:20:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPC00CInitial Entry
5.d
Date Location User Value Reason
Sep-23-2020 16:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLD1C9Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801178
Page 154 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.d Sample ID
Date Location User Value Reason
Sep-23-2020 16:20:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLD1C9Initial Entry
5.e
Date Location User Value Reason
Sep-23-2020 16:20:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLD1CBInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-23-2020 16:20:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLD1CBInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801179
Page 155 of 190
***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: 11291045 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-01-2021 12:41:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801180
Page 156 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-23-2021 13:13:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-23-2021 13:13:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-23-2021 13:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-23-2021 13:13:49
(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-23-2021 13:13:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/16/2021Initial Entry
5.a
Date Location User Value Reason
Feb-23-2021 13:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BTZPJ6Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801181
Page 157 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.a Sample ID
Date Location User Value Reason
Feb-23-2021 13:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BTZPJ6Initial Entry
5.b
Date Location User Value Reason
Feb-23-2021 13:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BTZPJ7Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-23-2021 13:14:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BTZPJ7Initial Entry
5.c
Date Location User Value Reason
Feb-23-2021 13:14:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BTZPJ8Initial Entry
5.c Sample ID
Date Location User Value Reason
Feb-23-2021 13:14:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BTZPJ8Initial Entry
5.d
Date Location User Value Reason
Feb-23-2021 13:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSFMX5Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801182
Page 158 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
5.d Sample ID
Date Location User Value Reason
Feb-23-2021 13:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSFMX5Initial Entry
5.e
Date Location User Value Reason
Feb-23-2021 13:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSFMX6Initial Entry
5.e Sample ID
Date Location User Value Reason
Feb-23-2021 13:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSFMX6Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801183
Page 159 of 190
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/26/2020Form: 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: 11291045 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-26-2020 14:54:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/26/2020Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801184
Page 160 of 190
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/26/2020Form: UNPLANNED VISIT - 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Assessments
Date Location User Value Reason
Aug-26-2020 15:01:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-26-2020 14:55:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Aug-26-2020 14:55:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801185
Page 161 of 190
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/26/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Contact Type:
Date Location User Value Reason
Aug-26-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Aug-26-2020 15:01:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-26-2020 15:01:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Aug/26/2020
Contact Outcome:
VISIT NOT REQUIRED, INV
ESTIGATOR DECISIONTranscription Error
Aug-26-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Date
of Contact" is
missing.
Aug-26-2020 15:01:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Contact Outcome:
VISIT NOT REQUIRED, INV
ESTIGATOR DECISIONInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801186
Page 162 of 190
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/27/2020Form: 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: 11291045 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-08-2020 11:35:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/27/2020Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801187
Page 163 of 190
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/27/2020Form: UNPLANNED VISIT - 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Assessments
Date Location User Value Reason
Sep-08-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-08-2020 11:35:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Sep-08-2020 11:35:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801188
Page 164 of 190
***Confidential***
Header Text: c4591001
Visit: Unplanned 2 - Unscheduled Visit on
Aug/27/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Contact Type:
Date Location User Value Reason
Sep-08-2020 11:35:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Sep-08-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-08-2020 11:36:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Contact:
Aug/27/2020
Contact Outcome:
VISIT NOT REQUIRED, INV
ESTIGATOR DECISIONTranscription Error
Sep-08-2020 11:35:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Date
of Contact" is
missing.
Sep-08-2020 11:35:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Contact Outcome:
VISIT NOT REQUIRED, INV
ESTIGATOR DECISIONInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801189
Page 165 of 190
***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: 11291045 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-23-2020 14:32:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-23-2020 14:32:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-23-2020 14:32:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801190
Page 166 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Date Location User Value Reason
Feb-16-2021 14:32:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801191
Page 167 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
Date Location User Value Reason
Mar-01-2021 14:08:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801192
Page 168 of 190
***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, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Category:
Date Location User Value Reason
Feb-16-2021 14:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-16-2021 14:32:31
(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-04-2021 15:48:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response satisfies
query
Mar-01-2021 14:09:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Feb-24-2021 09:34:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Medical monitor_ If
the traumatic accident
was either a fall, then
fall needs to be
reported recorded as
additional/separate
AEs as well. See
specific CRF
completion guidelines
(8.50.2.2./falls).
Thanks
Feb-16-2021 14:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
compound fracture left wristInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0801193
Page 169 of 190
***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, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Feb-16-2021 14:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/31/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 14:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-16-2021 14:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-18-2021 04:19:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
Feb-16-2021 14:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE compound
fracture left wrist:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-16-2021 14:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801194
Page 170 of 190
***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, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
NO
Did this serious event result in d
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability/
incapacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important serio
us 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
Feb-16-2021 14:32:31
(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
Feb-16-2021 14:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHERInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801195
Page 171 of 190
***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, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
If Other, specify:
patient fell playing tennis
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-16-2021 14:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-16-2021 14:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-16-2021 14:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-16-2021 14:32:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-16-2021 14:32:31
(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
Feb-19-2021 02:49:57 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801196
Page 172 of 190
***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, Verified
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00) Eastern
Time (US & Canada)2021168659
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801197
Page 173 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Category:
Date Location User Value Reason
Mar-01-2021 14:08:15
(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-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
fallInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/31/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-01-2021 14:08:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-01-2021 14:08:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Jan/31/2021 UNK:UNKTranscription Error
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801198
Page 174 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Mar-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For fall End Date
31/Mar/2021, is a
future date relative
to when it was
entered on 01/Mar
/2021. Please
correct.
Mar-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Mar/31/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-04-2021 02:47:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Mar-03-2021 16:53:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Mar-03-2021 16:53:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOTranscription Error
Mar-03-2021 10:12:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened SAE RECON: FALL
(Onset
date:31JAN2021) is
not reported to Safety
database but marked
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801199
Page 175 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Mar-03-2021 10:11:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Deleted Query can be
addressed internally
Mar-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE fall:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Mar-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h 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 disabilit
y/incapacity?
NO
Is this serious event life threate
ning?
NOInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801200
Page 176 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Other medically important serio
us 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-01-2021 14:08:15
(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-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:
OTHER
If Other, specify:
trippedInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-01-2021 14:08:15
(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-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801201
Page 177 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Mar-01-2021 14:08:15
(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-04-2021 04:01:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-03-2021 13:12:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto Query
Mar-03-2021 13:12:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVED WI
TH SEQUELAETranscription Error
Mar-02-2021 03:53:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: Thanks for
your response. For
AE fall, response to
"What was the
outcome of this
adverse event?" is
'Not Recovered/Not
Resolved' but AE
End Date/Time is
present.
Mar-01-2021 14:08:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Mar-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For AE fall:
Response to "What
was the outcome of
this adverse event?"
is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Mar-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801202
Page 178 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-01-2021 14:08:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801203
Page 179 of 190
***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: 11291045 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-04-2021 07:30:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Closed Response satisfies
query
Mar-03-2021 11:58:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Deleted Close Auto Query
Mar-03-2021 11:58:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 4: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please either untick
the erroneous visit
button if visit
occurred, or mark any
forms containing data
within this visit as
Not Done/Not
Applicable at the
form level.
Mar-03-2021 11:58:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription Error
Mar-03-2021 11:58:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021Transcription Error
Mar-02-2021 06:27:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 3: Opened DM Q: As per form,
please confirm if this
visit is performed
erroneously and if yes
then please update the
data on ‘FURTHER
VACCINATION
CONFIRMATION
‘accordingly. Else
remove the response
ERRONEOUS
VISIT. Else clarify.
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b)
(4),
(b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0801204
Page 180 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Dec-30-2020 07:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed data has
been updated
Dec-29-2020 09:39:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per
query
Dec-28-2020 23:45:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Opened DM: Erroneous visit
is marked. However,
form level comment
is not present on
REVAX CONF form.
Please review and
add form level
comment by selecting
Not Done or Not
Applicable option on
REVAX CONF form
accordingly or else
clarify.
Dec-28-2020 13:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please check whether
other assessments are
performed at this
visit.
Dec-28-2020 13:21:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-28-2020 13:19:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please check whether
other assessments are
performed at this
visit.
Dec-18-2020 15:53:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/17/2020Initial Entry
2. Erroneous Visit
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801205
Page 181 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Date Location User Value Reason
Mar-03-2021 11:58:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: New Information
Dec-28-2020 13:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
Dec-28-2020 13:21:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Dec-28-2020 13:19:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801206
Page 182 of 190
***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
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 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
Mar-01-2021 12:40:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
Mar-01-2021 12:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Feb-25-2021 03:20:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Feb-24-2021 12:33:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Answered Changed data per
query
Feb-24-2021 12:33:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
Feb-24-2021 04:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 2: Reissued:Opened DM: since this is
erroneous visit.
Please go to right
side upper corner
icon and select Not
Applicable as form
level comment.
Feb-23-2021 11:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Transcription Error
Feb-23-2021 11:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Feb-22-2021 15:16:54 ACV0PFEINFP6000 Query 2: Opened Erroneous Visit is
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0801207
Page 183 of 190
***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
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00) Eastern
Time (US & Canada)marked, but data is
present. Please
untick the erroneous
visit button if visit
occurred, or mark
any forms
containing data
within this visit as
Not Done/Not
Applicable at the
form level
Feb-16-2021 14:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-16-2021 14:37:19
(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.
Feb-16-2021 14:37:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Initial Entry
Feb-16-2021 14:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-29-2020 09:39:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Dec-28-2020 13:22:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Dec-18-2020 15:53:37 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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-2021-5683-0801208
Page 184 of 190
***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
Site No: 1129 Site Name: (1129) Jacksonville Center for Clinical Research
Subject No: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00) Eastern
Time (US & Canada)Participant is willing to return fo
r Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirmed
to have received only placebo
at Vaccination 1/2
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0801209
Page 185 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-16-2021 14:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Feb/16/2021Initial Entry
Feb-16-2021 14:37:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Dec-31-2020 04:31:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-30-2020 10:59:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Dec-30-2020 10:59:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Dec-30-2020 02:44:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Reissued:Opened DM1: If there is no
data needs to be
updated on this form
then consider to
mark as Not
Applicable by
selecting form level
comment. Thank
you.
Dec-29-2020 09:39:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered Changed data per
query
Dec-29-2020 03:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened DM: If there is no
data needs to be
updated on this form
then consider to
mark as Not
Applicable by
selecting form level
comment. Thank
you.
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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),
(b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0801210
Page 186 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Dec-28-2020 13:20:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry: Transcription Error
Dec-18-2020 15:53:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Dec/17/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Mar-03-2021
15:14:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Clo
sedResponse satisfies
query
Mar-03-2021
11:58:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: An
swere
dChanged data per query
Mar-02-2021
06:29:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
2: Op
enedDM Query: Primary
Reason for Unblinding
is entered, however
corresponding data on
REVAX visit is
missing and REVAX
visit is marked as
ERRONEOUS. Please
verify and confirm the
data and update the
database accordingly.
Mar-02-2021
04:37:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
Mar-01-2021
12:46:58
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 Query
1: An
swere
dplease unfreeze Revax
Cont page (DOV) for
data correction. Visit is
no longer erroneous as
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (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)
(b) (4)
FDA-CBER-2021-5683-0801211
Page 187 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(US &
Canada)visit has been
performed.
Feb-24-2021
06:07:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7402794;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Feb-16-2021
14:38:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONInitial Entry
Feb-16-2021
14:37:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:Initial Entry
Dec-30-2020
10:59:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
Not A
pplica
bleInitial Entry
Dec-28-2020
13:20:32ACV0PFEINFP6000 Data
EntryTranscription Error
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0801212
Page 188 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
(UTC-05:00)
Eastern Time
(US &
Canada):
Dec-18-2020
15:53:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0801213
Page 189 of 190
***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: 11291045 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:25
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-23-2020 14:32:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-04-2020 14:46:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-04-2020 14:27:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Sep-23-2020 14:32:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/22/2020Initial Entry
Aug-04-2020 14:46:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/4/2020Initial Entry
Aug-04-2020 14:27:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/4/2020Initial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
FDA-CBER-2021-5683-0801214
Page 190 of 190
***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: 11291045 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 11:35:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae30ac\Final\Final On: 01-Apr-2021 04:12 (GMT)
(b) (4)
(b) (4),
(b) (6)
FDA-CBER-2021-5683-0801215