Document text
Page 1 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928000
Page 2 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/11/2020
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928001
Page 3 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Demography
1.Subject ID [11111092]
2.Birth Date: 1954
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928002
Page 4 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928003
Page 5 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928004
Page 6 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928005
Page 7 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Kidney stones]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2010
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Farsighted]
Start Date: UNK/UNK/2004
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Muscle spasms (back)]
Start Date: UNK/UNK/1983
Ongoing: YES
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928006
Page 8 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Overweight]
Start Date: UNK/UNK/2008
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/2002
Ongoing: YES
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928007
Page 9 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [248.6]
3.Unit: LB
4.Height: [72.5]
5.Unit: in
6.Body Mass Index: [33.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: FOREHEAD
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928008
Page 10 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [225457]
3.Randomization Group: [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928009
Page 11 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5C92]
5.bSample ID [BP5C93]
5.cSample ID [BP5C94]
5.dSample ID [BLD2R9]
5.eSample ID [BLD2RB]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928010
Page 12 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/11/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP5C95]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928011
Page 13 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/11/2020 11:11
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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928012
Page 14 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928013
Page 15 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928014
Page 16 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928015
Page 17 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928016
Page 18 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928017
Page 19 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928018
Page 20 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
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 [BPY9YJ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928019
Page 21 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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/1/2020 11:26
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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928020
Page 22 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928021
Page 23 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928022
Page 24 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928023
Page 25 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928024
Page 26 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BP9RK7]
5.bSample ID [BP9RK8]
5.cSample ID [BP9RK9]
5.dSample ID [BNW9KM]
5.eSample ID [BNW9KN]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928025
Page 27 of 315
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928026
Page 28 of 315
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/25/2021
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 [BP9R8K]
5.bSample ID [BP9R8L]
5.cSample ID [BP9R8M]
5.dSample ID [BRTJ04]
5.eSample ID [BRTJ05]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928027
Page 29 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928028
Page 30 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928029
Page 31 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928030
Page 32 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928031
Page 33 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: DATE OF VISIT - ILLNESS ONSET
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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit ERRONEOUS VISIT
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928032
Page 34 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Not Applicable
//Comments
2.Date of First Symptom
Started:Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? Not Applicable Comments
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? Not Applicable Comments
4.cSymptoms: NEW OR INCREASED SHORTNESS OF
BREATH
Was symptom present? Not Applicable Comments
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928033
Page 35 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
4.dSymptoms: CHILLS
Was symptom present? Not Applicable Comments
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? Not Applicable Comments
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? Not Applicable Comments
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? Not Applicable Comments
4.hSymptoms: DIARRHEA
Was symptom present? Not Applicable Comments
4.iSymptoms: VOMITING
Was symptom present? Not Applicable Comments
Symptoms - Other
5.Symptoms - Other Text: Not Applicable
[ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928034
Page 36 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
1. Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928035
Page 37 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Microbiology Specimen
1.Actual Date of Collection: //
2.Specimen Type:
3.Specimen Collection
Location:
4.Assay Code and
Description:
5.Device Type:
6.Trade Name:
7.Test Result:
8.Comments/Findings
/Details:[ ]
9.Trade Name Other, Specify: [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928036
Page 38 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: 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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928037
Page 39 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: 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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928038
Page 40 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: 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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928039
Page 41 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928040
Page 42 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928041
Page 43 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: 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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928042
Page 44 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
1. Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928043
Page 45 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928044
Page 46 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
1. Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928045
Page 47 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928046
Page 48 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
1. Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928047
Page 49 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928048
Page 50 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928049
Page 51 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928050
Page 52 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928051
Page 53 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928052
Page 54 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
1. Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928053
Page 55 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: OXYGENATION PARAMETERS
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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928054
Page 56 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928055
Page 57 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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.Start Date: //
6.Ongoing?
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928056
Page 58 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
1. Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928057
Page 59 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928058
Page 60 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928059
Page 61 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928060
Page 62 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928061
Page 63 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Unplanned Assessments
1.Assessments
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928062
Page 64 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/1/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928063
Page 65 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928064
Page 66 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928065
Page 67 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928066
Page 68 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
1.ADVERS
E EVEN
T 1 Intermittent Angioede
ma (lips) Sep/1/2020
UNK:UNK
NO
End Date Time:
Dec/24/2020 U
NK:UNK
Repeating
Pages
2.ADVERS
E EVEN
T 2 Intermittent Angioede
ma (tongue) Sep/1/2020
UNK:UNK
NO
End Date Time:
Dec/24/2020 U
NK:UNK
Repeating
Pages
3.ADVERS
E EVEN
T 3 Angioedema (right side
of face) Jan/29/202
1 UNK:UN
K NO
End Date Time:
Jan/31/2021 U
NK:UNK
Repeating
Pages
4.ADVERS
E EVEN
T 4 Angioedema (left hand
center palm to heel of h
and) Feb/6/2021
UNK:UNK
NO
End Date Time:
Feb/7/2021 UN
K:UNK
Repeating
Pages
5.ADVERS
E EVEN
T 5 Angioedema (left sole
of foot) Feb/6/2021
UNK:UNK
NO
End Date Time:Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928067
Page 69 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#CategoryAE Id
entifie
rAdverse Event Start DateIs the Adverse E
vent Still Ongoin
gForm Insta
nce
Feb/7/2021 UN
K:UNK
6.ADVERS
E EVEN
T 6 Angioedema (isolated a
round lips) Feb/20/202
1 UNK:UN
K NO
End Date Time:
Feb/21/2021 U
NK:UNK
Repeating
Pages
7.ADVERS
E EVEN
T 7 Angioedema (left side
of jaw bone area) Feb/23/202
1 UNK:UN
K NO
End Date Time:
Feb/25/2021 U
NK:UNK
Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928068
Page 70 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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)[Intermittent Angioedema (lips)]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/24/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928069
Page 71 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928070
Page 72 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928071
Page 73 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Intermittent Angioedema (tongue)]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/24/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928072
Page 74 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928073
Page 75 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928074
Page 76 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Angioedema (right side of face)]
4.Start Date Time: Jan/29/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/31/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928075
Page 77 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928076
Page 78 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928077
Page 79 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Angioedema (left hand center palm to heel of hand)]
4.Start Date Time: Feb/6/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/7/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928078
Page 80 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928079
Page 81 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928080
Page 82 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Angioedema (left sole of foot)]
4.Start Date Time: Feb/6/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/7/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928081
Page 83 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928082
Page 84 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928083
Page 85 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Angioedema (isolated around lips)]
4.Start Date Time: Feb/20/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/21/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928084
Page 86 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928085
Page 87 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928086
Page 88 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[Angioedema (left side of jaw bone area)]
4.Start Date Time: Feb/23/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/25/2021 UNK:UNK
6.Toxicity Grade: 1
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928087
Page 89 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928088
Page 90 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928089
Page 91 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928090
Page 92 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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[ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928091
Page 93 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1.1 VACCINATI
ONS NO Flulaval Qu
adrivalent Oct/2/
2020 Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928092
Page 94 of 315
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Flulaval Quadrivalent]
5.Date: Oct/2/2020
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928093
Page 95 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928094
Page 96 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928095
Page 97 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928096
Page 98 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928097
Page 99 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928098
Page 100 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928099
Page 101 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928100
Page 102 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928101
Page 103 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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?
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928102
Page 104 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928103
Page 105 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928104
Page 106 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928105
Page 107 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928106
Page 108 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928107
Page 109 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928108
Page 110 of 315
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928109
Page 111 of 315
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928110
Page 112 of 315
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/4/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928111
Page 113 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928112
Page 114 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928113
Page 115 of 315
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/1/2020
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928114
Page 116 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928115
Page 117 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 10:53:02 (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.
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928116
Page 118 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormAug-11-2020 12:19:42 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928117
Page 119 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormJan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
FormJan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
FormJan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928118
Page 120 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Jan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
1Jan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
1Jan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928119
Page 121 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Jan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
2Jan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
2Jan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928120
Page 122 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Jan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
3Jan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
3Jan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928121
Page 123 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4.aJan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
4.aJan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
4.aJan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928122
Page 124 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4.bJan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
4.bJan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
4.bJan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928123
Page 125 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4.cJan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
4.cJan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
4.cJan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928124
Page 126 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4.dJan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
4.dJan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
4.dJan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928125
Page 127 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4.eJan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
4.eJan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
4.eJan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928126
Page 128 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4.fJan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
4.fJan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
4.fJan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928127
Page 129 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4.gJan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
4.gJan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
4.gJan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928128
Page 130 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4.hJan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
4.hJan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
4.hJan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928129
Page 131 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - Comments
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4.iJan-13-2021 14:01:15 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
4.iJan-13-2021 14:00:58 (UTC-05:00)
Eastern Time (US & Canada)
4.iJan-13-2021 14:00:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928130
Page 132 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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 10:53:02 (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-01-2021 10:38:09 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Feb-26-2021 07:11:33 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928131
Page 133 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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.
N/A Feb-25-2021 13:32:22 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Jan-29-2021 12:48:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928132
Page 134 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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.
N/A Jan-27-2021 10:34:49 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Jan-26-2021 10:03:38 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928133
Page 135 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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.
N/A Jan-22-2021 09:21:08 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Jan-21-2021 10:38:39 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928134
Page 136 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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.
N/A Jan-13-2021 11:13:13 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Jan-06-2021 17:10:08 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928135
Page 137 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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.
N/A Jan-05-2021 15:10:34 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Oct-12-2020 14:22:55 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928136
Page 138 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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.
N/A Oct-01-2020 16:38:30 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Sep-15-2020 10:48:54 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928137
Page 139 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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.
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928138
Page 140 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-11-2020
12:18:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-11-2020
12:18:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928139
Page 141 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-11-2020
12:19:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Aug/11/2020Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928140
Page 142 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-11-2020
12:18:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11111092Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-11-2020
12:18:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1954Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-11-2020
12:19:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928141
Page 143 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-11-2020
12:19:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-11-2020
12:19:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928142
Page 144 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-11-2020
12:19:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928143
Page 145 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-11-2020
12:19:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-11-2020
12:19:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-11-2020
12:19:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928144
Page 146 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1.a
Date Location User Value Reason
Aug-11-2020
12:22:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Kidney sto
nes
Start Date
:UNK/UN
K/2008
Ongoing: NO
End Date
:
UNK/U
NK/201
0Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-11-2020
12:22:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928145
Page 147 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020
12:22:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Kidney stonesInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-11-2020
12:22:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-11-2020
12:22:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.b
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928146
Page 148 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-11-2020
12:22:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Farsight
ed
Start Date: UNK/U
NK/200
4
Ongoing: YESInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928147
Page 149 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.b Line/MH Number:
Date Location User Value Reason
Aug-11-2020
12:22:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020
12:22:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FarsightedInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-11-2020
12:22:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2004Initial Entry
1.b Ongoing:
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928148
Page 150 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-11-2020
12:22:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:Muscle sp
asms (bac
k)
Start Date
:UNK/UN
K/1983
Ongoing: YESInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928149
Page 151 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.c Line/MH Number:
Date Location User Value Reason
Aug-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Muscle spasms (back
)Initial Entry
1.c Start Date:
Date Location User Value Reason
Aug-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1983Initial Entry
1.c Ongoing:
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928150
Page 152 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-11-2020
12:23:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-11-2020
12:23:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Overwei
ght
Start Date: UNK/U
NK/200
8
Ongoing: YESInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928151
Page 153 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.d Line/MH Number:
Date Location User Value Reason
Aug-11-2020
12:23:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020
12:23:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
OverweightInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-11-2020
12:23:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2008Initial Entry
1.d Ongoing:
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928152
Page 154 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-11-2020
12:23:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-11-2020
12:23:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:Hyperte
nsion
Start Date: UNK/U
NK/200
2
Ongoing: YESInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928153
Page 155 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.e Line/MH Number:
Date Location User Value Reason
Aug-11-2020
12:23:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020
12:23:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-11-2020
12:23:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2002Initial Entry
1.e Ongoing:
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928154
Page 156 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-11-2020
12:23:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928155
Page 157 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date:
Date Location User Value Reason
Aug-11-2020
12:20:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-11-2020
12:20:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
248.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-11-2020
12:20:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LBInitial Entry
4. Height:
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928156
Page 158 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Aug-11-2020
12:20:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
72.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-11-2020
12:20:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-11-2020
12:20:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
33.2Initial Entry
7.a
Date Location User Value Reason
Aug-11-2020
12:20:47
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
Record Ide 1Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928157
Page 159 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Eastern Time (US
& Canada)ntifier::
Temperatur
e:98.4
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Aug-11-2020
12:20:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-11-2020
12:20:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
98.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-11-2020
12:20:47ACV0PFEINFP6000 Data Entry:
FInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928158
Page 160 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-05:00)
Eastern Time (US
& Canada)
7.a Temperature Location:
Date Location User Value Reason
Aug-11-2020
12:20:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928159
Page 161 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-11-2020
12:21:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-11-2020
12:21:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
225457Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928160
Page 162 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020
12:45:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020
12:45:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-11-2020
12:45:43
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-11-2020
12:45:27ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928161
Page 163 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-05:00)
Eastern Time
(US & Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-11-2020
12:45:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collecti
on:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020
12:45:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP5C9
2Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-11-2020
12:45:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP5C92Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928162
Page 164 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.b
Date Location User Value Reason
Aug-11-2020
12:45:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP5C9
3Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-11-2020
12:45:55
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP5C93Initial Entry
5.c
Date Location User Value Reason
Aug-11-2020
12:46:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP5C9
4Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928163
Page 165 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.c Sample ID
Date Location User Value Reason
Aug-11-2020
12:46:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP5C94Initial Entry
5.d
Date Location User Value Reason
Aug-11-2020
12:46:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BLD2
R9Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-11-2020
12:46:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLD2R9Initial Entry
5.e
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928164
Page 166 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-11-2020
12:46:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BLD2
RBInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-11-2020
12:46:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BLD2RBInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928165
Page 167 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020
12:30:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020
12:30:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-11-2020
12:31:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-11-2020
12:30:24ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
te'Sample
Collected?' is
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928166
Page 168 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-05:00)
Eastern Time
(US & Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-11-2020
12:30:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collecti
on:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020
12:31:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BP5C9
5Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-11-2020
12:31:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP5C95Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928167
Page 169 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-11-2020
12:21:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-11-2020
12:21:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-11-2020
12:21:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928168
Page 170 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-11-2020
12:21:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Aug/11/2020 11:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-11-2020
12:21:40
(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-11-2020
12:21:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-11-2020
12:21:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928169
Page 171 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-11-2020
12:21:40
(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-11-2020
12:21:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928170
Page 172 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-11-2020
12:21:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES - REACTOGEN
ICITY E-DIARY CO
LLECTED FOR THI
S SUBJECTInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928171
Page 173 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020
13:20:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928172
Page 174 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-01-2020
13:21:10
(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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928173
Page 175 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Sep-01-2020
13:21:10
(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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-01-2020
13:21:10
(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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928174
Page 176 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.b Symptom:
Date Location User Value Reason
Sep-01-2020
13:21:10
(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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928175
Page 177 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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-01-2020
13:21:10
(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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-01-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0928176
Page 178 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
13:21:10
(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-01-2020
13:21:10
(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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928177
Page 179 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.e
Date Location User Value Reason
Sep-01-2020
13:21:10
(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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928178
Page 180 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.e Symptom:
Date Location User Value Reason
Sep-01-2020
13:21:10
(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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EAInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928179
Page 181 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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-01-2020
13:21:10
(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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-01-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0928180
Page 182 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
13:21:10
(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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928181
Page 183 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.g Symptom:
Date Location User Value Reason
Sep-01-2020
13:21:10
(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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
NInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928182
Page 184 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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-01-2020
13:21:10
(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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928183
Page 185 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Sep-01-2020
13:21:10
(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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-01-2020
13:21:10
(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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928184
Page 186 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
13:21:10
(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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::SW
EL
LI
NGInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928185
Page 187 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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-01-2020
13:21:10
(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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020
13:21:10ACV0PFEINFP6000 Data Entry:
Injection Site PAIInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928186
Page 188 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(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-01-2020
13:21:10
(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-01-2020
13:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928187
Page 189 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020
13:31:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020Initial Entry
2.a
Date Location User Value Reason
Sep-01-2020
13:31:12
(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-01-2020
13:31:12
(UTC-05:00)ACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928188
Page 190 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Eastern Time (US
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-01-2020
13:31:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-01-2020
13:31:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-01-2020
13:31:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928189
Page 191 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020
15:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020
15:44:22
(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-01-2020
15:44:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-01-2020
15:44:22ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928190
Page 192 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-01-2020
15:44:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
15:44:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BPY9Y
JInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
15:44:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BPY9YJInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928191
Page 193 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020
13:31:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020
13:31:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020
13:31:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928192
Page 194 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Sep-01-2020
13:31:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sep/1/2020 11:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020
13:31:59
(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-01-2020
13:31:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020
13:31:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928193
Page 195 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020
13:31:59
(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-01-2020
13:31:59
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928194
Page 196 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-01-2020
16:38:40
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Oct/1/2020Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928195
Page 197 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-01-2020
16:39:09
(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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928196
Page 198 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-01-2020
16:39:09
(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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-01-2020
16:39:09
(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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928197
Page 199 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.b Symptom:
Date Location User Value Reason
Oct-01-2020
16:39:09
(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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HEInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928198
Page 200 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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-01-2020
16:39:09
(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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-01-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0928199
Page 201 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
16:39:09
(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-01-2020
16:39:09
(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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928200
Page 202 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.e
Date Location User Value Reason
Oct-01-2020
16:39:09
(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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928201
Page 203 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.e Symptom:
Date Location User Value Reason
Oct-01-2020
16:39:09
(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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EAInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928202
Page 204 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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-01-2020
16:39:09
(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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-01-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0928203
Page 205 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
16:39:09
(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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928204
Page 206 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.g Symptom:
Date Location User Value Reason
Oct-01-2020
16:39:09
(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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
NInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928205
Page 207 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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-01-2020
16:39:09
(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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928206
Page 208 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-01-2020
16:39:09
(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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-01-2020
16:39:09
(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
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928207
Page 209 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020
16:39:09
(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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::SW
EL
LI
NGInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928208
Page 210 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
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-01-2020
16:39:09
(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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020
16:39:09ACV0PFEINFP6000 Data Entry:
Injection Site PAIInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928209
Page 211 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(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-01-2020
16:39:09
(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-01-2020
16:39:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928210
Page 212 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020
16:39:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020
16:39:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020
16:40:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-01-2020
16:39:24ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928211
Page 213 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-01-2020
16:39:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020
16:40:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9RK
7Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020
16:40:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9RK7Initial Entry
5.b
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928212
Page 214 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Oct-01-2020
16:40:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9RK
8Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-01-2020
16:40:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9RK8Initial Entry
5.c
Date Location User Value Reason
Oct-01-2020
16:40:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9RK
9Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928213
Page 215 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.c Sample ID
Date Location User Value Reason
Oct-01-2020
16:40:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9RK9Initial Entry
5.d
Date Location User Value Reason
Oct-01-2020
16:41:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BNW9K
MInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-01-2020
16:41:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNW9KMInitial Entry
5.e
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928214
Page 216 of 315
***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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-01-2020
16:41:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample I
D:BNW9K
NInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-01-2020
16:41:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BNW9KNInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928215
Page 217 of 315
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-01-2021
10:38:09
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Feb/25/2021Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928216
Page 218 of 315
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-01-2021
10:39:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021
10:39:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021
10:39:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-01-2021
10:39:01ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928217
Page 219 of 315
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-05:00)
Eastern Time (US
& Canada)Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Mar-01-2021
10:39:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Feb/25/2021Initial Entry
5.a
Date Location User Value Reason
Mar-01-2021
10:39:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9R8
KInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-01-2021
10:39:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9R8KInitial Entry
5.b
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928218
Page 220 of 315
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Mar-01-2021
10:39:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9R8
LInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-01-2021
10:39:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9R8LInitial Entry
5.c
Date Location User Value Reason
Mar-01-2021
10:40:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID
:BP9R8
MInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928219
Page 221 of 315
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.c Sample ID
Date Location User Value Reason
Mar-01-2021
10:40:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BP9R8MInitial Entry
5.d
Date Location User Value Reason
Mar-01-2021
10:40:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRTJ04Initial Entry
5.d Sample ID
Date Location User Value Reason
Mar-01-2021
10:40:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRTJ04Initial Entry
5.e
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928220
Page 222 of 315
***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, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Mar-01-2021
10:41:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BRTJ05Initial Entry
5.e Sample ID
Date Location User Value Reason
Mar-01-2021
10:41:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
BRTJ05Initial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928221
Page 223 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021
02:41:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 2: Deleted Query is
invalid or does
not apply
Jan-19-2021
02:41:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 1: Deleted Query is
invalid or does
not apply
Jan-19-2021
00:45:18
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Query 3: Deleted Query is
invalid or does
not apply
Jan-13-2021
14:00:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Candidate Erroneous
Visit is
marked, but
date of visit is
entered. Please
check whether
other
assessments
are performed
at this visit.
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928222
Page 224 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Jan-13-2021
11:13:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Jan-13-2021
11:13:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Jan-13-2021
11:13:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Jan/6/2021Initial Entry
2. Erroneous Visit
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928223
Page 225 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: DATE OF VISIT - ILLNESS ONSET - 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: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Jan-13-2021
14:00:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
ERRONEOUS VISITInitial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Jan-13-2021
11:13:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928224
Page 226 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Jan-13-2021
14:01:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-13-2021
14:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-13-2021
14:00:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Jan-13-2021
14:01:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928225
Page 227 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Jan-13-2021
14:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-13-2021
14:00:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-13-2021
14:01:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-13-2021
14:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-13-2021
14:00:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928226
Page 228 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
4.a
Date Location User Value Reason
Jan-13-2021
14:01:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:Not App
licable
Symptom
Present:Not App
licableInitial Entry
Jan-13-2021
14:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:Not App
licable
Symptom
Present:Initial Entry
Jan-13-2021
14:00:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:Not App
licable
Symptom
Present:Not App
licableInitial Entry
4.a Symptoms:
Date Location User Value Reason
Jan-13-2021
14:00:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4.a Was symptom present?
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928227
Page 229 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Jan-13-2021
14:01:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-13-2021
14:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-13-2021
14:00:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4.b
Date Location User Value Reason
Jan-13-2021
14:01:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:Not App
licable
Symptom
Present:Not App
licableInitial Entry
Jan-13-2021
14:00:58
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000 Data Entry:
Symptoms
:Not App
licableInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928228
Page 230 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
& Canada) Symptom
Present:
Jan-13-2021
14:00:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Symptoms
:Not App
licable
Symptom
Present:Not App
licableInitial Entry
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928229
Page 231 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
4.b Symptoms:
Date Location User Value Reason
Jan-13-2021
14:00:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Jan-13-2021
14:01:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Jan-13-2021
14:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry: Initial Entry
Jan-13-2021
14:00:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4.c
Date Location User Value Reason
090177e196d8902c\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928230
Page 232 of 315
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Jan/06/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical
Research
Subject No: 11111092 Subject Initials: ---
Generated By: Generated
…[truncated]