125742 S1 M5 CRF c4591001 1111 11111099

Document text

Page 1 of 187
***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: 11111099 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
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928520
Page 2 of 187
***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: 11111099 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
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928521
Page 3 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Demography
1.Subject ID [11111099]
2.Birth Date: /1966
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928522
Page 4 of 187
***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: 11111099 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
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928523
Page 5 of 187
***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: 11111099 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
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928524
Page 6 of 187
***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: 11111099 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: [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928525
Page 7 of 187
***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: 11111099 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:[Farsighted]
Start Date: UNK/UNK/2009
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Back Pain]
Start Date: UNK/UNK/2019
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/2005
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Partial Hysterectomy]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928526
Page 8 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[broken tibia]
Start Date: UNK/UNK/1983
Ongoing: NO
End Date:
UNK/UNK/1983
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[broken fibula]
Start Date: UNK/UNK/1983
Ongoing: NO
End Date:
UNK/UNK/1983
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast augmentation]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Abnormal pap smear]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928527
Page 9 of 187
***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: 11111099 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: [130.4]
3.Unit: LB
4.Height: [61.5]
5.Unit: in
6.Body Mass Index: [24.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928528
Page 10 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/11/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928529
Page 11 of 187
***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: 11111099 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: [46829]
3.Randomization Group: [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928530
Page 12 of 187
***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: 11111099 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 [BP5C9R]
5.bSample ID [BP5C9S]
5.cSample ID [BP5C9T]
5.dSample ID [BLD2RM]
5.eSample ID [BLD2RN]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928531
Page 13 of 187
***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: 11111099 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 [BP5C9V]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928532
Page 14 of 187
***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: 11111099 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 17:27
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928533
Page 15 of 187
***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: 11111099 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
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928534
Page 16 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928535
Page 17 of 187
***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: 11111099 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
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
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928536
Page 18 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928537
Page 19 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Vital Signs
1.Date: Sep/22/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928538
Page 20 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928539
Page 21 of 187
***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: 11111099 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/22/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYB68]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928540
Page 22 of 187
***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: 11111099 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?YES
Date of First Delay:
Sep/2/2020
Reason(s) for Temporary Delay of Vaccination
FEVER OR ACUTE ILLNESS
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: Not Done
//Comments
5.Anatomical Location:
6.Body Side: Not Applicable Comments
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?Not Applicable Comments
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928541
Page 23 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/20/2020
2.Erroneous Visit
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928542
Page 24 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Form Comments
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?Not Applicable Comments
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928543
Page 25 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?Not Applicable Comments
3.Injection Site Location: Not Applicable Comments
4.Injection Site Body Side: Not Applicable Comments
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?Not Applicable Comments
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928544
Page 26 of 187
***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: 11111099 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/20/2020
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 [BPY9MW]
5.bSample ID [BPY9MX]
5.cSample ID [BPY9MY]
5.dSample ID [BRTHBK]
5.eSample ID [BRTHBL]
5.fSample ID [BRTHBM]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928545
Page 27 of 187
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928546
Page 28 of 187
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_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: 11111099 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 [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928547
Page 29 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928548
Page 30 of 187
***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: 11111099 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 [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928549
Page 31 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928550
Page 32 of 187
***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: 11111099 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 [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928551
Page 33 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 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:
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928552
Page 34 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928553
Page 35 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 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 [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928554
Page 36 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 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 [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928555
Page 37 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 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?
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928556
Page 38 of 187
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 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:
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928557
Page 39 of 187
***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: 11111099 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:
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928558
Page 40 of 187
***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: 11111099 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 [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928559
Page 41 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/02/2020Form: 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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928560
Page 42 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/02/2020Form: UNPLANNED VISIT
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928561
Page 43 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/02/2020Form: CONTACT OUTCOME - UNPLANNED
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Sep/2/2020
Contact Outcome:
VISIT NOT ARRANGED, REACTION NO LONGER PRESENT
3.Comments: [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928562
Page 44 of 187
***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: 11111099 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/20/2020
2.Phase of Disposition: VACCINATION
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [Subject refused second vaccination but will continue with follow-up procedures]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928563
Page 45 of 187
***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: 11111099 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: [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928564
Page 46 of 187
***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: 11111099 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:
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928565
Page 47 of 187
***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: 11111099 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 [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928566
Page 48 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  ANGIO-EDEMA BOT
H EYES Aug/23/2020 UN
K:UNK YES  Repeating
Pages
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928567
Page 49 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 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)[ANGIO-EDEMA BOTH EYES]
4.Start Date Time: Aug/23/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
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:
[Subject equates it to allergies as she is scheduled to see Allergist]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928568
Page 50 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 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?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928569
Page 51 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928570
Page 52 of 187
***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: 11111099 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[ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928571
Page 53 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart Da
teForm Instan
ce
 1. DELETED 1  VACCINATION
S NO  BENADRYL  Aug/23/
2020 Repeating
Pages
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928572
Page 54 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
*** THIS REPEATING FORM HAS BEEN DELETED ***
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).[BENADRYL ]
5.Date: Aug/23/2020
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928573
Page 55 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928574
Page 56 of 187
***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: 11111099 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?
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928575
Page 57 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928576
Page 58 of 187
***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: 11111099 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?
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928577
Page 59 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928578
Page 60 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928579
Page 61 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928580
Page 62 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 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:
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928581
Page 63 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928582
Page 64 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: 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: 11111099 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?
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928583
Page 65 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928584
Page 66 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928585
Page 67 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928586
Page 68 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928587
Page 69 of 187
***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: 11111099 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 [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928588
Page 70 of 187
***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: 11111099 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 [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928589
Page 71 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/27/2021
2.Erroneous Visit
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928590
Page 72 of 187
***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: 11111099 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
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928591
Page 73 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928592
Page 74 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928593
Page 75 of 187
***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: 11111099 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: [ ]
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928594
Page 76 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/20/2020
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928595
Page 77 of 187
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11111099 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
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928596
Page 78 of 187
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: 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: 11111099 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-01-2021 12:34:18 (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.
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928597
Page 79 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormAug-11-2020 18:00:35 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928598
Page 80 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormSep-22-2020 14:32:50 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928599
Page 81 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Sep-22-2020 14:32:50 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928600
Page 82 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2Sep-22-2020 14:32:50 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928601
Page 83 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Sep-22-2020 14:32:50 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928602
Page 84 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Sep-22-2020 14:32:50 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928603
Page 85 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5Sep-22-2020 14:32:50 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928604
Page 86 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aSep-22-2020 14:32:50 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928605
Page 87 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aSep-22-2020 14:32:50 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928606
Page 88 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6.aSep-22-2020 14:32:50 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928607
Page 89 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Sep-22-2020 14:39:00 (UTC-05:00) Eastern
Time (US & Canada)Subject refused second vaccination but willing to
continue in observational visits
4Sep-22-2020 14:33:59 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928608
Page 90 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
6Sep-22-2020 14:34:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928609
Page 91 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
11Sep-22-2020 14:34:21 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928610
Page 92 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
FormOct-22-2020 13:42:13 (UTC-05:00) Eastern
Time (US & Canada)Subject did not receive second vaccination
FormOct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928611
Page 93 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
1Oct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928612
Page 94 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2.aOct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928613
Page 95 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2.bOct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928614
Page 96 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2.cOct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928615
Page 97 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2.dOct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928616
Page 98 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2.eOct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928617
Page 99 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2 fOct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928618
Page 100 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2.gOct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928619
Page 101 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
2 hOct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928620
Page 102 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
3Oct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928621
Page 103 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
4Oct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928622
Page 104 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.aOct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928623
Page 105 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.bOct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928624
Page 106 of 187
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - Comments
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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
ItemDate User Comment
5.cOct-22-2020 13:39:04 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928625
Page 107 of 187
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 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-01-2021 12:34:18 (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 Feb-25-2021 14:44:38 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Feb-25-2021 06:15:36 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
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-12-2021 14:38:53 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928626
Page 108 of 187
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Michael
Stephens Approved Nov-16-2020 08:23:27 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
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 Nov-09-2020 14:03:13 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Nov-06-2020 10:26:21 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
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 Nov-03-2020 09:03:59 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Oct-28-2020 12:58:24 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928627
Page 109 of 187
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 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-22-2020 13:37:14 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Oct-12-2020 14:30:11 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
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 Sep-22-2020 14:30:44 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Stephens Approved Sep-15-2020 10:46:39 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
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.
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928628
Page 110 of 187
***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: 11111099 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 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-11-2020 18:00:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928629
Page 111 of 187
***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: 11111099 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 18:00:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/11/2020Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928630
Page 112 of 187
***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: 11111099 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 17:59:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11111099Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-11-2020 17:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1966Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-11-2020 18:00:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-11-2020 18:00:21
(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 18:00:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928631
Page 113 of 187
***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: 11111099 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 18:00:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928632
Page 114 of 187
***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: 11111099 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 18:00:49
(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 18:00:49
(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 18:00:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928633
Page 115 of 187
***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: 11111099 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 18:25:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Farsighted
Start Date: UNK/UNK/2
009
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:25:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 18:25:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FarsightedInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-11-2020 18:25:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-11-2020 18:25:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
090177e196d8902d\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-2021-5683-0928634
Page 116 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Aug-11-2020 18:26:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:Back Pain
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:26:07
(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 18:26:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Back PainInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-11-2020 18:26:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-11-2020 18:26:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-11-2020 18:27:00
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196d8902d\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-2021-5683-0928635
Page 117 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Time (US & Canada) Medical History T
erm:Hypothyroidi
sm
Start Date: UNK/UNK/2
005
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:27:00
(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 18:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypothyroidismInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-11-2020 18:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-11-2020 18:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-11-2020 18:27:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Partial Hysterec
tomyInitial Entry
090177e196d8902d\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-2021-5683-0928636
Page 118 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Start Date: UNK/UNK/201
2
Ongoing: NO
End Date:
UNK/UNK/2
012
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928637
Page 119 of 187
***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: 11111099 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 18:27:33
(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-13-2020 09:51:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Aug-13-2020 08:27:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered update medical
history per patient:
abnormal pap
smear.
Aug-12-2020 13:05:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened Please add the
corresponding
medical condition
for this procedure as
a separate medical
history item.
Aug-11-2020 18:27:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Partial HysterectomyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-11-2020 18:27:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-11-2020 18:27:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
090177e196d8902d\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) (4)
(b) (4)
FDA-CBER-2021-5683-0928638
Page 120 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
1.e
Date Location User Value Reason
Aug-11-2020 18:28:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:broken tibia
Start Date: UNK/UNK/198
3
Ongoing: NO
End Date:
UNK/UNK/
1983Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928639
Page 121 of 187
***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: 11111099 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 18:28:36
(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 18:28:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
broken tibiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-11-2020 18:28:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1983Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-11-2020 18:28:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1983Initial Entry
1.f
Date Location User Value Reason
Aug-11-2020 18:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:broken fibula
Start Date: UNK/UNK/198
3Initial Entry
090177e196d8902d\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-2021-5683-0928640
Page 122 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Ongoing: NO
End Date:
UNK/UNK/
1983
1.f Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 18:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
broken fibulaInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-11-2020 18:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1983Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-11-2020 18:28:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1983Initial Entry
1.g
Date Location User Value Reason
Aug-11-2020 18:29:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7Initial Entry
090177e196d8902d\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-2021-5683-0928641
Page 123 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Medical History
Term:Breast augment
ation
Start Date: UNK/UNK/200
4
Ongoing: NO
End Date:
UNK/UNK/
2004
1.g Line/MH Number:
Date Location User Value Reason
Aug-11-2020 18:29:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 18:29:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Breast augmentationInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-11-2020 18:29:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-11-2020 18:29:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
1.h
Date Location User Value Reason
090177e196d8902d\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-2021-5683-0928642
Page 124 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Aug-13-2020 08:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:Abnormal pap s
mear
Start Date: UNK/UNK/201
2
Ongoing: NO
End Date:
UNK/UNK/
2012Initial Entry
1.h Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 08:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Abnormal pap smearInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-13-2020 08:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-13-2020 08:26:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
090177e196d8902d\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-2021-5683-0928643
Page 125 of 187
***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: 11111099 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 18:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-11-2020 18:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
130.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-11-2020 18:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-11-2020 18:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
61.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-11-2020 18:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-11-2020 18:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24.2Initial Entry
090177e196d8902d\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-2021-5683-0928644
Page 126 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
7.a
Date Location User Value Reason
Aug-11-2020 18:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 99.0
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-11-2020 18:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-11-2020 18:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
99.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-11-2020 18:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-11-2020 18:23:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d8902d\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-2021-5683-0928645
Page 127 of 187
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-11-2020 18:24:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-11-2020 18:24:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-11-2020 18:24:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-11-2020 18:24:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-11-2020 18:24:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-11-2020 18:24:03
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928646
Page 128 of 187
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Aug-11-2020 18:24:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-11-2020 18:24:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-11-2020 18:24:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928647
Page 129 of 187
***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: 11111099 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 18:24:26
(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 18:24:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
46829Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928648
Page 130 of 187
***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: 11111099 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 18:12:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020 18:12:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-11-2020 18:12:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-11-2020 18:12:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-11-2020 18:12:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020 18:12:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5C9RInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928649
Page 131 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a Sample ID
Date Location User Value Reason
Aug-11-2020 18:12:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP5C9RInitial Entry
5.b
Date Location User Value Reason
Aug-11-2020 18:12:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5C9SInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-11-2020 18:12:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP5C9SInitial Entry
5.c
Date Location User Value Reason
Aug-11-2020 18:12:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5C9TInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-11-2020 18:12:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP5C9TInitial Entry
5.d
Date Location User Value Reason
Aug-11-2020 18:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLD2RMInitial Entry
090177e196d8902d\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), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928650
Page 132 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.d Sample ID
Date Location User Value Reason
Aug-11-2020 18:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLD2RMInitial Entry
5.e
Date Location User Value Reason
Aug-11-2020 18:13:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLD2RNInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-11-2020 18:13:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLD2RNInitial Entry
090177e196d8902d\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-2021-5683-0928651
Page 133 of 187
***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: 11111099 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 18:01:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020 18:01:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-11-2020 18:01:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-11-2020 18:01:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-11-2020 18:01:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020 18:01:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP5C9VInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928652
Page 134 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a Sample ID
Date Location User Value Reason
Aug-11-2020 18:01:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP5C9VInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928653
Page 135 of 187
***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: 11111099 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 18:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-11-2020 18:24:44
(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 18:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-11-2020 18:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020 17:27Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-11-2020 18:24:44
(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 18:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196d8902d\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-2021-5683-0928654
Page 136 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
7. Route:
Date Location User Value Reason
Aug-11-2020 18:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-11-2020 18:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-11-2020 18:24:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928655
Page 137 of 187
***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: 11111099 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 18:24:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR TH
IS SUBJECTInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928656
Page 138 of 187
***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: 11111099 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-22-2020 14:30:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928657
Page 139 of 187
***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: 11111099 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-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIGInitial Entry
090177e196d8902d\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-2021-5683-0928658
Page 140 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196d8902d\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-2021-5683-0928659
Page 141 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.c Symptom:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196d8902d\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-2021-5683-0928660
Page 142 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
090177e196d8902d\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-2021-5683-0928661
Page 143 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.f Symptom:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d8902d\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-2021-5683-0928662
Page 144 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.h
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196d8902d\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-2021-5683-0928663
Page 145 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196d8902d\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-2021-5683-0928664
Page 146 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-22-2020 14:31:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d8902d\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-2021-5683-0928665
Page 147 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date:
Date Location User Value Reason
Sep-22-2020 14:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/22/2020Initial Entry
2.a
Date Location User Value Reason
Sep-22-2020 14:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.4
Temperature Unit: F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-22-2020 14:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-22-2020 14:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-22-2020 14:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196d8902d\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-2021-5683-0928666
Page 148 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Sep-22-2020 14:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928667
Page 149 of 187
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-22-2020 14:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-22-2020 14:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-22-2020 14:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-22-2020 14:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-22-2020 14:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Sep-22-2020 14:32:50
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry: Initial Entry
090177e196d8902d\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), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928668
Page 150 of 187
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Time (US & Canada) Sponsor-Defined Identi
fier:Not Do
ne
Test:: Not Do
ne
Result:: Not Do
ne
Not Done:: Not Do
ne
6.a Sponsor ID:
Date Location User Value Reason
Sep-22-2020 14:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Sep-22-2020 14:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Sep-22-2020 14:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-22-2020 14:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196d8902d\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-2021-5683-0928669
Page 151 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 15:41:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 15:41:44
(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-22-2020 15:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-22-2020 15:41:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-22-2020 15:41:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/22/2020Initial Entry
5.a
Date Location User Value Reason
Sep-22-2020 15:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYB68Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928670
Page 152 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a Sample ID
Date Location User Value Reason
Sep-22-2020 15:42:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPYB68Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928671
Page 153 of 187
***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: 11111099 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-22-2020 14:33:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of First Delay:
Sep/2/2020
Reason(s) for Temporary Delay
of Vaccination
FEVER OR ACUTE ILLNESSInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-22-2020 14:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-22-2020 14:34:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-22-2020 14:34:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196d8902d\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-2021-5683-0928672
Page 154 of 187
***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: 11111099 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-26-2020 15:29:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-26-2020 09:39:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject was not
unblinded or
withdrew consent
so not sure why I
would need to fill
out treatment disp
eCRF. Updated
EOT.
Oct-26-2020 07:19:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM:As per CRF
guidelines, the
treatment period is
defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination. Hence,
please complete
treatment
disposition CRF
and update date of
EOT to match the
date the Visit 3.
Oct-22-2020 13:37:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
090177e196d8902d\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-2021-5683-0928673
Page 155 of 187
***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: 11111099 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-26-2020 05:20:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-23-2020 09:19:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Please clarify as
patient did not have
second vaccine due
to Angioedema AE
Oct-23-2020 04:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: Vaccination is
given, however
FORM level
comment added as
NOT Applicable
added on
‘Vaccination
Symptoms Diary-
Symptom Resolved
Dates’ CRF. Please
review , as eDairy
data available in
trail max report else
clarify.
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.a
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:Not
Appl
icabl
eInitial Entry
090177e196d8902d\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-2021-5683-0928674
Page 156 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.a Symptom:
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.b
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:Not
Appl
icabl
eInitial Entry
2.b Symptom:
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.c
090177e196d8902d\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-2021-5683-0928675
Page 157 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:Not
Appl
icabl
eInitial Entry
2.c Symptom:
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.d
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:Not
Appl
icabl
eInitial Entry
090177e196d8902d\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-2021-5683-0928676
Page 158 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.d Symptom:
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.e
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:Not
Appl
icabl
eInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.f
090177e196d8902d\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-2021-5683-0928677
Page 159 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:Not
Appl
icabl
eInitial Entry
2.f Symptom:
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.g
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:Not
Appl
icabl
eInitial Entry
090177e196d8902d\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-2021-5683-0928678
Page 160 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
2.g Symptom:
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.h
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: Not
Appl
icabl
e
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:Not
Appl
icabl
eInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Injection Site Location:
090177e196d8902d\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-2021-5683-0928679
Page 161 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: Not
Appl
icabl
e
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.b
Date Location User Value Reason
090177e196d8902d\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-2021-5683-0928680
Page 162 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: Not
Appl
icabl
e
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: Not
Appl
icabl
e
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:Not
Appl
icabl
eInitial Entry
090177e196d8902d\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-2021-5683-0928681
Page 163 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-22-2020 13:39:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928682
Page 164 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-23-2020 09:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-23-2020 09:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-23-2020 09:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-23-2020 09:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-23-2020 09:57:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
5.a
Date Location User Value Reason
Oct-23-2020 09:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY9MWInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928683
Page 165 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.a Sample ID
Date Location User Value Reason
Oct-23-2020 09:58:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY9MWInitial Entry
5.b
Date Location User Value Reason
Oct-23-2020 09:58:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY9MXInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-23-2020 09:58:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY9MXInitial Entry
5.c
Date Location User Value Reason
Oct-23-2020 09:58:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY9MYInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-23-2020 09:58:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY9MYInitial Entry
5.d
Date Location User Value Reason
Oct-23-2020 09:59:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTHBKInitial Entry
090177e196d8902d\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)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0928684
Page 166 of 187
***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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
5.d Sample ID
Date Location User Value Reason
Oct-23-2020 09:59:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTHBKInitial Entry
5.e
Date Location User Value Reason
Oct-23-2020 09:59:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTHBLInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-23-2020 09:59:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTHBLInitial Entry
5.f
Date Location User Value Reason
Oct-23-2020 09:59:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTHBMInitial Entry
5.f Sample ID
Date Location User Value Reason
Oct-23-2020 09:59:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTHBMInitial Entry
090177e196d8902d\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-2021-5683-0928685
Page 167 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/02/2020Form: 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: 11111099 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-15-2020 09:44:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928686
Page 168 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/02/2020Form: UNPLANNED VISIT - 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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Assessments
Date Location User Value Reason
Sep-15-2020 09:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 09:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Sep-15-2020 09:44:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928687
Page 169 of 187
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/02/2020Form: CONTACT OUTCOME - UNPLANNED - 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: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Contact Type:
Date Location User Value Reason
Sep-15-2020 09:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Sep-15-2020 09:45:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Sep/2/2020
Contact Outcome:
VISIT NOT ARRANGED, RE
ACTION NO LONGER PRES
ENTInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928688
Page 170 of 187
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 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
Oct-26-2020 09:37:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020 09:37:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-13-2020 14:07:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Luke Cunliffe Query 4: Closed Response satisfies
query
Nov-09-2020 15:12:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 5: Closed Response satisfies
query
Nov-09-2020 14:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Answered Changed
Information
Nov-09-2020 14:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WITHDRAWAL BY SUBJEC
TChanged
Information
Nov-07-2020 10:23:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 5: Opened CLINQUERY: Per
information
provided, treatment
was finally
discontinued (after
temp delay) because
subject declined to
receive the second
vaccination. If
correct, please enter
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0928689
Page 171 of 187
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
WITHDRAWAL BY
SUBJECT in this
field to capture end
of Rx
Nov-06-2020 09:12:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered I keep receiving
different queries
regarding the correct
status for this
subject. Please
advise a FINAL time
what the correct
status should be as
the site assesses the
status to be protocol
deviation since V2
was not taken.
Nov-05-2020 20:15:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened ClinQuery: EOT
status =
PROTOCOL
DEVIATION. It is
unclear why this
status was selected
considering the
reason for
discontinuation
provided in the
‘specify status’ field.
Please review and
update status, or
otherwise clarify.
Nov-04-2020 09:37:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-03-2020 09:04:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Nov-03-2020 09:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Response to "Status"
is PROTOCOL
DEVIATION but
"Specify Status" is
missing.
Nov-03-2020 09:03:59
(UTC-05:00) EasternACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed
Information
090177e196d8902d\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-2021-5683-0928690
Page 172 of 187
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Time (US & Canada)
Nov-03-2020 09:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PROTOCOL DEVIATIONChanged
Information
Nov-03-2020 07:27:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 2: Opened DM: Per completion
guidelines, ’If the
Participant receives
all vaccinations as
per protocol and
completes follow-up
visit procedures
within 1-month post
vaccination period,
report status as
COMPLETED’.
Kindly review and
update CRF as
needed. Else clarify
Nov-02-2020 15:59:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-02-2020 14:13:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject chose to not
receive V2 to due
allergic reactions.
She did not
withdraw consent or
choose to
discontinue.
Nov-02-2020 13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 1: Opened Subject has not
received vaccination
2, but status of end
of treatment
disposition is entered
as COMPLETED.
Please verify and
update accordingly,
else clarify. Thank
you.
Oct-26-2020 09:37:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196d8902d\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) (4)
(b) (4)
FDA-CBER-2021-5683-0928691
Page 173 of 187
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
4. Specify Status:
Date Location User Value Reason
Nov-03-2020 09:04:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Subject refused second vaccinatio
n but will continue with follow-up
proceduresInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928692
Page 174 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928693
Page 175 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Category:
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ANGIO-EDEMA BOTH EYESInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196d8902d\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-2021-5683-0928694
Page 176 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 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).
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Sep-15-2020 10:34:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Sep-15-2020 10:14:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Sep-15-2020 10:14:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
Subject equates it to allergi
es as she is scheduled to see
AllergistChanged
Information
Sep-11-2020 18:59:44 ACV0PFEINFP6000  Quan Jason Query 1: Opened GPDClin: I do not
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0928695
Page 177 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
(UTC-05:00) Eastern
Time (US & Canada)Gong see a relevant past
medical history as
indicated here.
Please add it to the
MHx module.
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
PART OF PAST MEDICA
L HISTORYInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
090177e196d8902d\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)
(b) (4)
FDA-CBER-2021-5683-0928696
Page 178 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-10-2020 10:00:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928697
Page 179 of 187
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Sep-14-2020 08:57:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Sep-10-2020 10:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928698
Page 180 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Sep-10-2020 10:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Sep-10-2020 10:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Sep-10-2020 10:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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).
Date Location User Value Reason
Sep-16-2020 00:34:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-14-2020 08:57:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered deleted per query
advisement
Sep-13-2020 21:05:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
BENADRYL: Please
note this is not a
vaccination and is
not required to be
090177e196d8902d\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-2021-5683-0928699
Page 181 of 187
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
*** THIS REPEATING FORM HAS BEEN DELETED ***
listed on the CM
Vax log. Please
remove as
appropriate. Thanks
Sep-10-2020 10:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BENADRYLInitial Entry
5. Date:
Date Location User Value Reason
Sep-10-2020 10:01:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/23/2020Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928700
Page 182 of 187
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021 14:45:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/27/2021Transcription Error
Feb-12-2021 14:39:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/12/2021Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928701
Page 183 of 187
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-12-2021 14:39:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at V
accination 1/2Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928702
Page 184 of 187
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Feb-26-2021
02:31:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies
query
Feb-25-2021
14:44:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
Feb-25-2021
14:44:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Feb/1
2/202
1Transcription Error
Feb-23-2021
02:18:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7351367;Date
Treatment Unblinded
should be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Feb-12-2021
14:38:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Jan/27
/2021Initial Entry
2. Primary Reason for Unblinding:
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0928703
Page 185 of 187
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Date Location User Value Reason
Feb-12-2021 14:38:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0928704
Page 186 of 187
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-09-2020 14:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged
Information
Nov-03-2020 09:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDChanged
Information
Oct-26-2020 09:37:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-11-2020 18:24:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-11-2020 18:00:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-09-2020 14:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/20/2020Changed
Information
Nov-03-2020 09:03:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/20/2020Changed
Information
Oct-26-2020 09:37:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/20/2020Initial Entry
Aug-11-2020 18:24:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/11/2020Initial Entry
Aug-11-2020 18:00:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/11/2020Initial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4)
FDA-CBER-2021-5683-0928705
Page 187 of 187
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1111 Site Name: (1111) Fleming Island Center for Clinical Research
Subject No: 11111099 Subject Initials: ---
Generated By: Generated Time (GMT): 21-Apr-2021 18:02
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-15-2020 09:15:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196d8902d\Final\Final On: 22-Apr-2021 02:13 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0928706