Document text
Page 1 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929613
Page 2 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/14/2020
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929614
Page 3 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11111109]
2.Birth Date: 1964
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929615
Page 4 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/14/2020
2.Erroneous Visit
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929616
Page 5 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929617
Page 6 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929618
Page 7 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Tubal ligation]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Post-menopause]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Uterine ablation]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929619
Page 8 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Gallstones]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Cholecystectomy]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Diverticulosis]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929620
Page 9 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Carpal tunnel syndrome (right)]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Sleep apnea]
Start Date: UNK/UNK/2013
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Kidney stones]
Start Date: UNK/UNK/1997
Ongoing: NO
End Date:
UNK/UNK/1997
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929621
Page 10 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Farsighted]
Start Date: UNK/UNK/2015
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Disseminated porokeratosis]
Start Date: UNK/UNK/2013
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Overweight]
Start Date: UNK/UNK/1970
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/1997
Ongoing: YES
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929622
Page 11 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [167.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [26.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.9]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929623
Page 12 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and
Address (Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929624
Page 13 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [228730]
3.Randomization Group: [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929625
Page 14 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/14/2020
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 [BP5CC2]
5.bSample ID [BP5CC3]
5.cSample ID [BP5CC4]
5.dSample ID [BLD2S9]
5.eSample ID [BLD2SB]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929626
Page 15 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/14/2020
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 [BP5CC5]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929627
Page 16 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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/14/2020 13:26
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929628
Page 17 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929629
Page 18 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929630
Page 19 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929631
Page 20 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929632
Page 21 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929633
Page 22 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929634
Page 23 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and
Address (Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929635
Page 24 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BPYB1S]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929636
Page 25 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/4/2020 16:56
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929637
Page 26 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929638
Page 27 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929639
Page 28 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929640
Page 29 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929641
Page 30 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
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 [BP9RM2]
5.bSample ID [BP9RM3]
5.cSample ID [BP9RM4]
5.dSample ID [BNW9LV]
5.eSample ID [BNW9LW]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929642
Page 31 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929643
Page 32 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
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 [BRNVJM]
5.bSample ID [BRNVJN]
5.cSample ID [BRNVJP]
5.dSample ID [BNWPLP]
5.eSample ID [BNWPLR]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929644
Page 33 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929645
Page 34 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929646
Page 35 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929647
Page 36 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929648
Page 37 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929649
Page 38 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929650
Page 39 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929651
Page 40 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929652
Page 41 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929653
Page 42 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929654
Page 43 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929655
Page 44 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929656
Page 45 of 229
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929657
Page 46 of 229
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929658
Page 47 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929659
Page 48 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929660
Page 49 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929661
Page 50 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929662
Page 51 of 229
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Pyelonep
hritis Sep/28/2020 U
NK:UNK NO
End Date Time:
Oct/2/2020 UNK:U
NK
Repeating
Pages
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929663
Page 52 of 229
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[Pyelonephritis]
4.Start Date Time: Sep/28/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/2/2020 UNK:UNK
6.Toxicity Grade: 2
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929664
Page 53 of 229
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[kidney stones/nephrolithiasis]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929665
Page 54 of 229
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2020383628]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929666
Page 55 of 229
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929667
Page 56 of 229
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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[ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929668
Page 57 of 229
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929669
Page 58 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: //
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929670
Page 59 of 229
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929671
Page 60 of 229
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929672
Page 61 of 229
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929673
Page 62 of 229
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929674
Page 63 of 229
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929675
Page 64 of 229
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929676
Page 65 of 229
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929677
Page 66 of 229
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929678
Page 67 of 229
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929679
Page 68 of 229
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929680
Page 69 of 229
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929681
Page 70 of 229
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929682
Page 71 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929683
Page 72 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929684
Page 73 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929685
Page 74 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929686
Page 75 of 229
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929687
Page 76 of 229
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929688
Page 77 of 229
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929689
Page 78 of 229
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929690
Page 79 of 229
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929691
Page 80 of 229
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/5/2020
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929692
Page 81 of 229
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929693
Page 82 of 229
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-05-2021 11:42:55 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929694
Page 83 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-14-2020 15:21:33 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929695
Page 84 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormAug-14-2020 15:39:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929696
Page 85 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Aug-14-2020 15:39:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929697
Page 86 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Aug-14-2020 15:39:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929698
Page 87 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Aug-14-2020 15:39:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929699
Page 88 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Aug-14-2020 15:39:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929700
Page 89 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Aug-14-2020 15:39:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929701
Page 90 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6.aAug-14-2020 15:39:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929702
Page 91 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6.aAug-14-2020 15:39:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929703
Page 92 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6.aAug-14-2020 15:39:52 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929704
Page 93 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-08-2020 13:55:39 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929705
Page 94 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
1Sep-08-2020 13:55:39 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929706
Page 95 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
2Sep-08-2020 13:55:39 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929707
Page 96 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
3Sep-08-2020 13:55:39 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929708
Page 97 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
4Sep-08-2020 13:55:39 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929709
Page 98 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
5Sep-08-2020 13:55:39 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929710
Page 99 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6.aSep-08-2020 13:55:39 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929711
Page 100 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6.aSep-08-2020 13:55:39 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929712
Page 101 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
6.aSep-08-2020 13:55:39 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929713
Page 102 of 229
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Approved Mar-05-2021 11:42:55 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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 Mar-03-2021 15:31:32 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Oct-12-2020 14:37:40 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929714
Page 103 of 229
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Affidavit:
By my dated signature below, I, MichaelStephens, 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.
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929715
Page 104 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-14-2020
15:21:00
(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-14-2020
15:21:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929716
Page 105 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-14-2020
15:21:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/14/2020Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929717
Page 106 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-14-2020
15:20:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11111109Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-14-2020
15:20:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1964Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-14-2020
15:21:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929718
Page 107 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:21:18
(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-14-2020
15:21:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929719
Page 108 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-14-2020
15:21:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929720
Page 109 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-14-2020
15:23:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-14-2020
15:23:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-14-2020
15:23:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929721
Page 110 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Aug-14-2020
15:24:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Tubal ligat
ion
Start Date
:UNK/UN
K/1998
Ongoing: NO
End Date
:
UNK/U
NK/199
8Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-14-2020
15:24:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929722
Page 111 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020
15:24:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Tubal ligationInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-14-2020
15:24:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1998Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-14-2020
15:24:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
1.b
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929723
Page 112 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Post-me
nopause
Start Date: UNK/U
NK/201
7
Ongoing: YESInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929724
Page 113 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.b Line/MH Number:
Date Location User Value Reason
Aug-14-2020
15:25:11
(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-14-2020
15:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Post-menopauseInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-14-2020
15:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929725
Page 114 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:25:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-14-2020
15:25:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:Uterine abl
ation
Start Date
:UNK/UN
K/2016
Ongoing: NO
End Date
:
UNK/U
NK/201
6Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929726
Page 115 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.c Line/MH Number:
Date Location User Value Reason
Aug-14-2020
15:25:37
(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-14-2020
15:25:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Uterine ablationInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-14-2020
15:25:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929727
Page 116 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:25:37
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Eastern Time (US
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1.d
Date Location User Value Reason
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15:26:10
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Eastern Time (US
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(autocalc)Data Entry:
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istory Ter
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FDA-CBER-2021-5683-0929728
Page 117 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.d Line/MH Number:
Date Location User Value Reason
Aug-14-2020
15:26:10
(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:
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Aug-14-2020
15:26:10
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Eastern Time (US
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GallstonesInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-14-2020
15:26:10
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(b) (4),
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FDA-CBER-2021-5683-0929729
Page 118 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
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Aug-14-2020
15:26:10
(UTC-05:00)
Eastern Time (US
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Date Location User Value Reason
Aug-14-2020
15:31:09
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Eastern Time (US
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istory Ter
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2Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
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FDA-CBER-2021-5683-0929730
Page 119 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.e Line/MH Number:
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Aug-14-2020
15:31:09
(UTC-05:00)
Eastern Time (US
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(autocalc)Data Entry:
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1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
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15:31:09
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Eastern Time (US
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CholecystectomyInitial Entry
1.e Start Date:
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Aug-14-2020
15:31:09
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090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
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(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0929731
Page 120 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:31:09
(UTC-05:00)
Eastern Time (US
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NO
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1.f
Date Location User Value Reason
Aug-14-2020
15:31:49
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Eastern Time (US
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(autocalc)Data Entry:
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umber:6
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tory Term:Divertic
ulosis
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NK/201
0
Ongoing: YESInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
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(b) (4)
FDA-CBER-2021-5683-0929732
Page 121 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.f Line/MH Number:
Date Location User Value Reason
Aug-14-2020
15:31:49
(UTC-05:00)
Eastern Time (US
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(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
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Aug-14-2020
15:31:49
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Eastern Time (US
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DiverticulosisInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-14-2020
15:31:49
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Eastern Time (US
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UNK/UNK/2010Initial Entry
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Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
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(b) (4),
(b) (6)
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FDA-CBER-2021-5683-0929733
Page 122 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:31:49
(UTC-05:00)
Eastern Time (US
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YESInitial Entry
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Aug-14-2020
15:32:45
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Eastern Time (US
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(autocalc)Data Entry:
Line/M
H Numb
er:7
Medical
History
Term:Carpal tunne
l syndrome (
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te:UNK/UNK/
2014
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:NO
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UNK/UN
K/2014Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
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(b) (4)
FDA-CBER-2021-5683-0929734
Page 123 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.g Line/MH Number:
Date Location User Value Reason
Aug-14-2020
15:32:45
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Eastern Time (US
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(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
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Aug-14-2020
15:32:45
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Eastern Time (US
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Carpal tunnel syndro
me (right)Initial Entry
1.g Start Date:
Date Location User Value Reason
Aug-14-2020
15:32:45
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Eastern Time (US
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UNK/UNK/2014Initial Entry
1.g Ongoing:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
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(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929735
Page 124 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:32:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
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UNK/UNK/2014Initial Entry
1.h
Date Location User Value Reason
Aug-14-2020
15:33:07
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Eastern Time (US
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(autocalc)Data Entry:
Line/MH N
umber:8
Medical His
tory Term:Sleep ap
nea
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NK/201
3
Ongoing: YESInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929736
Page 125 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.h Line/MH Number:
Date Location User Value Reason
Aug-14-2020
15:33:07
(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-14-2020
15:33:07
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Eastern Time (US
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Sleep apneaInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-14-2020
15:33:07
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Eastern Time (US
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UNK/UNK/2013Initial Entry
1.h Ongoing:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
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(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929737
Page 126 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:33:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-14-2020
15:33:37
(UTC-05:00)
Eastern Time (US
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(autocalc)Data Entry:
Line/MH
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istory Ter
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nes
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K/1997
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:
UNK/U
NK/199
7Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
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(b) (4)
FDA-CBER-2021-5683-0929738
Page 127 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.i Line/MH Number:
Date Location User Value Reason
Aug-14-2020
15:33:37
(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-14-2020
15:33:37
(UTC-05:00)
Eastern Time (US
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Kidney stonesInitial Entry
1.i Start Date:
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Aug-14-2020
15:33:37
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Eastern Time (US
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UNK/UNK/1997Initial Entry
1.i Ongoing:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929739
Page 128 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:33:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1997Initial Entry
1.j
Date Location User Value Reason
Aug-14-2020
15:33:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:10
Medical His
tory Term:Farsight
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NK/201
5
Ongoing: YESInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929740
Page 129 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.j Line/MH Number:
Date Location User Value Reason
Aug-14-2020
15:33:52
(UTC-05:00)
Eastern Time (US
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(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020
15:33:52
(UTC-05:00)
Eastern Time (US
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FarsightedInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-14-2020
15:33:52
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Eastern Time (US
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UNK/UNK/2015Initial Entry
1.j Ongoing:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
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(b) (4),
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(b) (4)
FDA-CBER-2021-5683-0929741
Page 130 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:33:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929742
Page 131 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.k
Date Location User Value Reason
Aug-14-2020
15:34:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:11
Medical
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erm:Disseminat
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atosis
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e:UNK/UN
K/2013
Ongoing: YESInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929743
Page 132 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.k Line/MH Number:
Date Location User Value Reason
Aug-14-2020
15:34:44
(UTC-05:00)
Eastern Time (US
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(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020
15:34:44
(UTC-05:00)
Eastern Time (US
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Disseminated poroke
ratosisInitial Entry
1.k Start Date:
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Aug-14-2020
15:34:44
(UTC-05:00)
Eastern Time (US
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UNK/UNK/2013Initial Entry
1.k Ongoing:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929744
Page 133 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:34:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-14-2020
15:34:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:12
Medical Hi
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NK/197
0
Ongoing: YESInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929745
Page 134 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.l Line/MH Number:
Date Location User Value Reason
Aug-14-2020
15:34:58
(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-14-2020
15:34:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OverweightInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-14-2020
15:34:58
(UTC-05:00)
Eastern Time (US
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UNK/UNK/1970Initial Entry
1.l Ongoing:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929746
Page 135 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:34:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-14-2020
15:35:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:13
Medical Hi
story Term:Hyperte
nsion
Start Date: UNK/U
NK/199
7
Ongoing: YESInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929747
Page 136 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.m Line/MH Number:
Date Location User Value Reason
Aug-14-2020
15:35:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020
15:35:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-14-2020
15:35:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1997Initial Entry
1.m Ongoing:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929748
Page 137 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:35:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929749
Page 138 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Aug-14-2020
15:39:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-14-2020
15:39:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
167.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-14-2020
15:39:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929750
Page 139 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-14-2020
15:39:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-14-2020
15:39:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-14-2020
15:39:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
26.2Initial Entry
7.a
Date Location User Value Reason
Aug-14-2020
15:39:40
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Record Ide 1Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929751
Page 140 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time (US
& Canada)ntifier::
Temperatur
e:98.9
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Aug-14-2020
15:39:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-14-2020
15:39:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.9Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-14-2020
15:39:40ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929752
Page 141 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)
7.a Temperature Location:
Date Location User Value Reason
Aug-14-2020
15:39:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929753
Page 142 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-14-2020
15:39:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-14-2020
15:39:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-14-2020
15:39:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929754
Page 143 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Aug-14-2020
15:39:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-14-2020
15:39:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Aug-14-2020
15:39:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defi
ned Identifier
:Not
Done
Test:: Not
Done
Result:: Not
Done
Not Done:: Not
DoneInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929755
Page 144 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
6.a Sponsor ID:
Date Location User Value Reason
Aug-14-2020
15:39:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Aug-14-2020
15:39:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Aug-14-2020
15:39:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929756
Page 145 of 229
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:39:52
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929757
Page 146 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-14-2020
15:40:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-14-2020
15:40:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
228730Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929758
Page 147 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020
18:31:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020
18:31:00
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020
18:31:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-14-2020
18:31:00ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929759
Page 148 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time
(US & Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-14-2020
18:31:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collecti
on:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020
18:31:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP5C
C2Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020
18:31:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP5CC2Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929760
Page 149 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.b
Date Location User Value Reason
Aug-14-2020
18:31:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP5C
C3Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-14-2020
18:31:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP5CC3Initial Entry
5.c
Date Location User Value Reason
Aug-14-2020
18:32:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP5C
C4Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929761
Page 150 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c Sample ID
Date Location User Value Reason
Aug-14-2020
18:32:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP5CC4Initial Entry
5.d
Date Location User Value Reason
Aug-14-2020
18:32:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BLD2
S9Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-14-2020
18:32:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLD2S9Initial Entry
5.e
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929762
Page 151 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
18:32:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BLD2S
BInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-14-2020
18:32:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLD2SBInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929763
Page 152 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020
17:37:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020
17:37:31
(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-14-2020
17:37:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-14-2020
17:37:31ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929764
Page 153 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time
(US & Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-14-2020
17:37:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collecti
on:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020
17:37:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP5C
C5Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020
17:37:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP5CC5Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929765
Page 154 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-14-2020
15:41:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-14-2020
15:41:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-14-2020
15:41:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929766
Page 155 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Aug-14-2020
15:41:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/14/2020 13:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-14-2020
15:41:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-14-2020
15:41:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-14-2020
15:41:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929767
Page 156 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-14-2020
15:41:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Aug-14-2020
15:41:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929768
Page 157 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-14-2020
15:41:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929769
Page 158 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020
13:54:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929770
Page 159 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929771
Page 160 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-08-2020
13:54:57
(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-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:N
OInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929772
Page 161 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.b Symptom:
Date Location User Value Reason
Sep-08-2020
13:54:57
(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-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929773
Page 162 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NO
2.c Symptom:
Date Location User Value Reason
Sep-08-2020
13:54:57
(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-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-08-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0929774
Page 163 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: C
HI
L
L
S
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
O
2.d Symptom:
Date Location User Value Reason
Sep-08-2020
13:54:57
(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-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929775
Page 164 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.e
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NOInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929776
Page 165 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.e Symptom:
Date Location User Value Reason
Sep-08-2020
13:54:57
(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-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EAInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929777
Page 166 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
O
2.f Symptom:
Date Location User Value Reason
Sep-08-2020
13:54:57
(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-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-08-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0929778
Page 167 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever o
r systemic sy
mptoms pre
sent on the l
ast day the S
ubject Diary
was complet
ed?:NO
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929779
Page 168 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.g Symptom:
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
NInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929780
Page 169 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.h Symptom:
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929781
Page 170 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-08-2020
13:54:57
(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-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was com
pleted?:N
OInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929782
Page 171 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020
13:54:57
(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-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::SW
EL
LI
NGInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929783
Page 172 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020
13:54:57
(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-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-08-2020
13:54:57ACV0PFEINFP6000 Data Entry:
Injection Site PAIInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929784
Page 173 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)Reaction:: N AT
INJE
CTI
ON
SITE
Were injectio
n site reaction
s present on t
he last day th
e Subject Dia
ry was compl
eted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-08-2020
13:54:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929785
Page 174 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020
13:55:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-08-2020
13:55:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:97.5
Temperatu
re Unit:F
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-08-2020
13:55:21
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929786
Page 175 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time (US
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-08-2020
13:55:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-08-2020
13:55:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-08-2020
13:55:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929787
Page 176 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-08-2020
13:55:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-08-2020
13:55:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-08-2020
13:55:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929788
Page 177 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-08-2020
13:55:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-08-2020
13:55:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Sep-08-2020
13:55:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sponsor-Defi
ned Identifier
:Not
Done
Test:: Not
Done
Result:: Not
Done
Not Done:: Not
DoneInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929789
Page 178 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
6.a Sponsor ID:
Date Location User Value Reason
Sep-08-2020
13:55:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Sep-08-2020
13:55:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Sep-08-2020
13:55:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929790
Page 179 of 229
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-08-2020
13:55:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not DoneInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929791
Page 180 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-09-2020
10:35:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-09-2020
10:35:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020
10:35:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-09-2020
10:35:09ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929792
Page 181 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-09-2020
10:35:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-09-2020
10:35:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPYB1
SInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-09-2020
10:35:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPYB1SInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929793
Page 182 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020
13:56:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020
13:56:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020
13:56:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929794
Page 183 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-08-2020
13:56:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/4/2020 16:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020
13:56:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-08-2020
13:56:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-08-2020
13:56:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929795
Page 184 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-08-2020
13:56:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-08-2020
13:56:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929796
Page 185 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020
10:53:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929797
Page 186 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929798
Page 187 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-06-2020
10:54:43
(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
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:N
OInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929799
Page 188 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.b Symptom:
Date Location User Value Reason
Oct-06-2020
10:54:43
(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
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929800
Page 189 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:NO
2.c Symptom:
Date Location User Value Reason
Oct-06-2020
10:54:43
(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
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-06-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0929801
Page 190 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: C
HI
L
L
S
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
O
2.d Symptom:
Date Location User Value Reason
Oct-06-2020
10:54:43
(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
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929802
Page 191 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.e
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:NOInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929803
Page 192 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.e Symptom:
Date Location User Value Reason
Oct-06-2020
10:54:43
(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
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EAInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929804
Page 193 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
O
2.f Symptom:
Date Location User Value Reason
Oct-06-2020
10:54:43
(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
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-06-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0929805
Page 194 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AIN
Were fever o
r systemic sy
mptoms pre
sent on the l
ast day the S
ubject Diary
was complet
ed?:NO
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929806
Page 195 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
2.g Symptom:
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
NInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929807
Page 196 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.h Symptom:
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929808
Page 197 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-06-2020
10:54:43
(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
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was com
pleted?:N
OInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929809
Page 198 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-06-2020
10:54:43
(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
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::SW
EL
LI
NGInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929810
Page 199 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-06-2020
10:54:43
(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
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-06-2020
10:54:43ACV0PFEINFP6000 Data Entry:
Injection Site PAIInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929811
Page 200 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)Reaction:: N AT
INJE
CTI
ON
SITE
Were injectio
n site reaction
s present on t
he last day th
e Subject Dia
ry was compl
eted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-06-2020
10:54:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929812
Page 201 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020
15:00:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020
15:00:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020
15:00:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-06-2020
15:00:19ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929813
Page 202 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-06-2020
15:00:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020
15:00:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9RM
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020
15:00:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9RM2Initial Entry
5.b
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929814
Page 203 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-06-2020
15:00:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9RM
3Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-06-2020
15:00:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9RM3Initial Entry
5.c
Date Location User Value Reason
Oct-06-2020
15:00:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9RM
4Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929815
Page 204 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.c Sample ID
Date Location User Value Reason
Oct-06-2020
15:00:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9RM4Initial Entry
5.d
Date Location User Value Reason
Oct-06-2020
15:01:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BNW9L
VInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-06-2020
15:01:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNW9LVInitial Entry
5.e
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929816
Page 205 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Oct-06-2020
15:01:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BNW9L
WInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-06-2020
15:01:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNW9LWInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929817
Page 206 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021
10:25:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-09-2021
09:52:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered uploaded
Mar-05-2021
14:45:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Please upload
v4_month6
source to
Florence
Mar-03-2021
15:31:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Mar/3/2021Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929818
Page 207 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-04-2021
15:06:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-04-2021
15:06:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-05-2021
13:35:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Mar-04-2021
15:06:38ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto
Query
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929819
Page 208 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time (US
& Canada)
Mar-04-2021
15:06:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-04-2021
15:06:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Mar-04-2021
15:06:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Mar/3/2021Initial Entry
Mar-04-2021
12:02:28
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Opened Please
complete
missing page.
5.a
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929820
Page 209 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Mar-04-2021
15:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BRNVJ
MInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-04-2021
15:06:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRNVJMInitial Entry
5.b
Date Location User Value Reason
Mar-04-2021
15:06:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRNVJ
NInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929821
Page 210 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.b Sample ID
Date Location User Value Reason
Mar-04-2021
15:06:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRNVJNInitial Entry
5.c
Date Location User Value Reason
Mar-04-2021
15:07:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BRNVJ
PInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-04-2021
15:07:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRNVJPInitial Entry
5.d
Date Location User Value Reason
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929822
Page 211 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Mar-04-2021
15:07:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BNWPL
PInitial Entry
5.d Sample ID
Date Location User Value Reason
Mar-04-2021
15:07:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNWPLPInitial Entry
5.e
Date Location User Value Reason
Mar-04-2021
15:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BNWPL
RInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929823
Page 212 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.e Sample ID
Date Location User Value Reason
Mar-04-2021
15:07:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNWPLRInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929824
Page 213 of 229
***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: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-06-2020
10:52:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-06-2020
10:52:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-06-2020
10:52:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929825
Page 214 of 229
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Oct-05-2020
10:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929826
Page 215 of 229
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Oct-05-2020
10:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-05-2020
10:06:13
(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
Oct-05-2020
10:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
PyelonephritisInitial Entry
4. Start Date Time:
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929827
Page 216 of 229
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-05-2020
10:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/28/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-05-2020
10:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Oct/2/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020
09:57:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2Transcription
Error
Oct-05-2020
10:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
3Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929828
Page 217 of 229
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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
Oct-30-2020
20:51:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Closed Clinical Thank
you. Please
report the
negative COVID
test result with
the DATE
performed on a
follow-up SAE
form [lab test
section], as a
pertinent
negative test
result for this
trial.
Oct-30-2020
15:43:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Answer
edper patient
report, she had
COVID swab but
it was
negative...records
pending
Oct-28-2020 ACV0PFEINFP6000 Query 3: Opened Clinical – While
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929829
Page 218 of 229
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
04:25:10
(UTC-05:00)
Eastern Time
(US & Canada)awaiting
additional
records, please
submit Awaiting
Med Records to
Determine if
COVID testing
was Performed as
a SAE safety
followup.
Oct-27-2020
21:56:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 3: Candida
teClinical – While
awaiting
additional
records, please
submit Awaiting
Med Records to
Determine if
COVID testing
was Performed as
a SAE safety
followup.
Oct-26-2020
22:36:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Closed Query closed;
will follow for
SAE update
containing
requested
COVID test info,
when med
records arrive
Oct-23-2020
11:36:33ACV0PFEINFP6000 Query 2: Answer
edAwaiting medical
records so no
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929830
Page 219 of 229
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-05:00)
Eastern Time
(US & Canada)definitive
information
received. Will
submit follow-up
when
information
received
Oct-22-2020
23:12:01
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 2: Opened Clinical -
COVID testing
has not been
reported in the
SAE submitted to
safety. Please
submit a
follow-up SAE
form
[#2020383628]
to provide
whether COVID
testing was
performed
(yes/no) and if
yes, the results.
Oct-06-2020
07:01:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-05-2020
10:06:13
(UTC-05:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
teFor AE
Pyelonephritis:
Response to "Is
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929831
Page 220 of 229
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time
(US & Canada)the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Oct-05-2020
10:06:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious e
vent associated
with congenital
anomaly or birt
h defect?
NO
Did this serious
event result in d
eath?
NO
Did this serious
event require or
prolong hospita
lization?
YES
Did this serious
event result in p
ersistent or sign
ificant disabilitInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929832
Page 221 of 229
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
y/incapacity?
NO
Is this serious e
vent life threate
ning?
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
Oct-05-2020
10:06:13
(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
Oct-06-2020
10:59:47
(UTC-05:00)ACV0PFEINFP6000 Query 1: Close
dResponse satisfies
query
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929833
Page 222 of 229
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time
(US & Canada)
Oct-05-2020
14:21:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answ
eredChanged Information
Oct-05-2020
14:21:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATE
D
If Not Relate
d to study tre
atment(s), thi
s event is due
to:
OTHER
If Other, s
pecify:
kidney st
ones/nep
hrolithia
sisChanged Information
Oct-05-2020
13:30:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Query 1: Open
edCLINICAL please
confirm if kidney
stones/nephrolithiasis
were involved with
the etiology of this
current event, as
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929834
Page 223 of 229
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
SAE reports 'kidney
stone infection' and
placement of a renal
stent
Oct-05-2020
10:06:13
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATE
D
If Not Relate
d to study tre
atment(s), thi
s event is due
to:
OTHER
If Other, s
pecify:
unknow
nInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-05-2020
10:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929835
Page 224 of 229
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Oct-05-2020
10:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-05-2020
10:06:13
(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
Oct-05-2020
10:06:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-05-2020
10:06:13
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0929836
Page 225 of 229
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time (US
& Canada)
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-06-2020
07:01:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
2020383628Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0929837
Page 226 of 229
***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, Queries, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-12-2021
14:24:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:
OpenedThank you for
your response.
Pls confirm if a
FU letter will
be sent with the
symptoms of
onset.
Mar-11-2021
14:14:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered We were asked
to provide
symptoms for
onset of SAE
but not asked to
update safety
report. Please
state that from
onset. Kind
regards.
Mar-11-2021
14:08:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Reissued:
OpenedThank you for
confirming.
However, this
information is
missing in the
safety report.
Please provide
a FU letter with
symptoms of
onset to be
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0929838
Page 227 of 229
***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, Queries, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
added to the
SAE report.
Thanks
Mar-11-2021
10:26:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Answered lower
abdominal pain
and fevers
Mar-08-2021
15:14:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened Medical
monitor_ Pls
provide
symptoms of
onset for SAE
of
Pyelonephritis
(AER#
2020383628).
Thanks
Oct-06-2020
10:52:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-14-2020
15:40:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RAN
DOMIZEDInitial Entry
Aug-14-2020
15:23:25
(UTC-05:00)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0929839
Page 228 of 229
***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, Queries, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Eastern Time (US
& Canada)
2. Subject Status Date
Date Location User Value Reason
Oct-06-2020
10:52:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/5/2020Initial Entry
Aug-14-2020
15:40:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
Aug-14-2020
15:23:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0929840
Page 229 of 229
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111109 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-12-2020
10:49:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e4e\Final\Final On: 01-Apr-2021 04:52 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0929841