125742 45 S211 M5 c4591001 1005 10051449

Document text

Page 1 of 177
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 version01 DEC 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492786
Page 2 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/11/2021
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492787
Page 3 of 177
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Demography
1.Subject ID [10051449]
2.Birth Date: /2006
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2022-5812-0492788
Page 4 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492789
Page 5 of 177
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492790
Page 6 of 177
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathJan/11/2021
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492791
Page 7 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[ENVIRONMENTAL ALLERGIES]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492792
Page 8 of 177
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492793
Page 9 of 177
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Jan/11/2021
2.Weight: [182.2]
3.Unit: LB
4.Height: [70.2]
5.Unit: in
6.Body Mass Index: [26.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492794
Page 10 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Jan/11/2021
2.Randomization Number: [24137]
3.Randomization Group: [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492795
Page 11 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/11/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRF7RX]
5.bSample ID [BRF7RY]
5.cSample ID [BRF7RZ]
5.dSample ID [BS331X]
5.eSample ID [BS331Y]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492796
Page 12 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/11/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRL2LG]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492797
Page 13 of 177
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: Jan/11/2021 12:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492798
Page 14 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR
THIS SUBJECT
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492799
Page 15 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492800
Page 16 of 177
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492801
Page 17 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492802
Page 18 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492803
Page 19 of 177
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Vital Signs
1.Date: Feb/1/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492804
Page 20 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/1/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRF83R]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492805
Page 21 of 177
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: Feb/1/2021 11:21
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492806
Page 22 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492807
Page 23 of 177
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492808
Page 24 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
3.Injection Site Location: DELTOID MUSCLE
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492809
Page 25 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492810
Page 26 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZMLL]
5.bSample ID [BPZMLM]
5.cSample ID [BPZMLN]
5.dSample ID [BSC2X4]
5.eSample ID [BSC2X5]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492811
Page 27 of 177
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/2/2021
2.Erroneous Visit
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492812
Page 28 of 177
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/2/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BLZK00]
5.bSample ID [BLX1NX]
5.cSample ID [BLX1NY]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492813
Page 29 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492814
Page 30 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492815
Page 31 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492816
Page 32 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492817
Page 33 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492818
Page 34 of 177
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 30-Apr-2021 01:47 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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: [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492819
Page 35 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492820
Page 36 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492821
Page 37 of 177
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 30-Apr-2021 01:37 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492822
Page 38 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492823
Page 39 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492824
Page 40 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492825
Page 41 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492826
Page 42 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492827
Page 43 of 177
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492828
Page 44 of 177
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Unplanned Assessments
1.Assessments
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492829
Page 45 of 177
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492830
Page 46 of 177
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 30-Apr-2021 01:41 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492831
Page 47 of 177
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492832
Page 48 of 177
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492833
Page 49 of 177
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492834
Page 50 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492835
Page 51 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492836
Page 52 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492837
Page 53 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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 [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492838
Page 54 of 177
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/1/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492839
Page 55 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit May/13/2021
2.Erroneous Visit
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492840
Page 56 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492841
Page 57 of 177
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Form Comments
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Not Done
//Comments
2.Phase of Disposition: Not Done Comments
3.Status: Not Done Comments
4.Specify Status: Not Done
[ ]Comments
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492842
Page 58 of 177
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Appendic
itis Jun/28/2021 U
NK:UNK NO
End Date Time:
Jun/29/2021 UNK:
UNK
 Repeating
Pages
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492843
Page 59 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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)[Appendicitis]
4.Start Date Time: Jun/28/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jun/29/2021 UNK:UNK
6.Toxicity Grade: 2
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492844
Page 60 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or
birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492845
Page 61 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[202101108305]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492846
Page 62 of 177
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
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(b) (4)
FDA-CBER-2022-5812-0492847
Page 63 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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[ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492848
Page 64 of 177
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492849
Page 65 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492850
Page 66 of 177
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492851
Page 67 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492852
Page 68 of 177
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492853
Page 69 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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?
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492854
Page 70 of 177
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492855
Page 71 of 177
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492856
Page 72 of 177
***Confidential***
 
Header Text: c4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492857
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***Confidential***
 
Header Text: c4591001
Visit:
UNPLANNED_BOOSTER_CONTACT
- UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 13-Apr-2021 01:26 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Booster Dose Trigger Form
1.Select appropriate response
- Will the participant return
for consent/eligibility
assessment for the booster
dose visit?
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492858
Page 74 of 177
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : May/17/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492859
Page 75 of 177
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492860
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***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492861
Page 77 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Mar/1/2021
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492862
Page 78 of 177
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492863
Page 79 of 177
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492864
Page 80 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormJan-12-2021 06:51:21 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492865
Page 81 of 177
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
FormMar-16-2021 15:03:42 (UTC-05:00)
Eastern Time (US & Canada)inadvertently entered page
Not Done
FormMar-16-2021 15:03:07 (UTC-05:00)
Eastern Time (US & Canada)inadvertently entered page
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492866
Page 82 of 177
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
1Mar-16-2021 15:03:42 (UTC-05:00)
Eastern Time (US & Canada)inadvertently entered page
Not Done
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0492867
Page 83 of 177
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
2Mar-16-2021 15:03:42 (UTC-05:00)
Eastern Time (US & Canada)inadvertently entered page
Not Done
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0492868
Page 84 of 177
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
3Mar-16-2021 15:03:42 (UTC-05:00)
Eastern Time (US & Canada)inadvertently entered page
Not Done
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0492869
Page 85 of 177
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
ItemDate User Comment
4Mar-16-2021 15:03:42 (UTC-05:00)
Eastern Time (US & Canada)inadvertently entered page
Not Done
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0492870
Page 86 of 177
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A May-17-2021 12:48:05 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Davis Approved Mar-17-2021 11:01:29 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDavis, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this
subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked
Submit below.
 N/A Mar-16-2021 15:03:07 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (6)
(b) (6)
FDA-CBER-2022-5812-0492871
Page 87 of 177
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Affidavit:
N/A
Matthew
Davis Approved Mar-12-2021 14:01:31 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492872
Page 88 of 177
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Jan-12-2021
06:50:24
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
01 DEC 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Jan-12-2021
06:50:24
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492873
Page 89 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-12-2021
06:50:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
OBTAINED
Date Written Consent Ob
tained
Jan/11/2021Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492874
Page 90 of 177
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject ID
Date Location User Value Reason
Jan-12-2021 06:50:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
10051449Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Jan-12-2021 06:50:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
/2006Enrollment Entry
3. Sex:
Date Location User Value Reason
Jan-12-2021
06:50:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Jan-12-2021
06:50:59
(UTC-05:00)
Eastern Time (US &ACV0PF
EINFP60
00 Data Entry:
HISPANIC OR LATINO(
A) OR OF SPANISH ORI
GINInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492875
Page 91 of 177
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
5. Race: (Check X all that apply):
Date Location User Value Reason
Jan-12-2021
06:50:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
WHITEInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492876
Page 92 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-12-2021
06:51:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/11/2021Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492877
Page 93 of 177
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Jan-12-2021
06:51:36
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/11/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-12-2021 06:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jan-12-2021
06:51:36
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492878
Page 94 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1.a
Date Location User Value Reason
Jan-12-2021 06:51:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical Hi
story Term
:ENVIRONMEN
TAL ALLERGI
ES
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jan-12-2021 06:51:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Jan-12-2021
06:51:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
ENVIRONMENTAL ALL
ERGIESInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492879
Page 95 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
1.a Start Date:
Date Location User Value Reason
Jan-12-2021
06:51:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jan-12-2021
06:51:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492880
Page 96 of 177
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Jan-12-2021
06:52:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
The subject is NOT known
to be HIV POSITIVEInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492881
Page 97 of 177
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Jan-12-2021
06:52:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/11/2021Initial Entry
2. Weight:
Date Location User Value Reason
Jan-12-2021
06:52:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
182.2Initial Entry
3. Unit:
Date Location User Value Reason
Jan-12-2021
06:52:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492882
Page 98 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-12-2021
06:52:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
70.2Initial Entry
5. Unit:
Date Location User Value Reason
Jan-12-2021
06:52:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Jan-12-2021 06:52:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
26.0Initial Entry
7.a
Date Location User Value Reason
Jan-12-2021
06:52:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identi
fier::1
Temperature: 96.7
Temperature
Unit:FInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492883
Page 99 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Temperature
Location::ORAL C
AVITY
7.a Record Identifier:
Date Location User Value Reason
Jan-12-2021
06:52:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jan-12-2021
16:10:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Jan-12-2021
06:54:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Query 1: Answered NCS PER PI
Jan-12-2021
06:52:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Temperature
96.7 F is
outside of
Normal Range
97 - 99.5 F.
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492884
Page 100 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-12-2021
06:52:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PF
EINFP60
00 Data Entry:
96.7Initial Entry
7.a Unit:
Date Location User Value Reason
Jan-12-2021
06:52:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Jan-12-2021
06:52:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492885
Page 101 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Jan-12-2021
06:52:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Jan/11/2021Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jan-12-2021
06:52:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
24137Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492886
Page 102 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-12-2021 06:53:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-12-2021 06:53:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-12-2021
06:53:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-12-2021
06:53:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492887
Page 103 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-12-2021
06:53:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
5.a
Date Location User Value Reason
Jan-12-2021
06:53:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRF7RXInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-12-2021
06:53:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRF7RXInitial Entry
5.b
Date Location User Value Reason
Jan-12-2021
06:54:05
(UTC-05:00)
Eastern Time (US &ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRF7RYInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492888
Page 104 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
5.b Sample ID
Date Location User Value Reason
Jan-12-2021
06:54:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRF7RYInitial Entry
5.c
Date Location User Value Reason
Jan-12-2021
06:54:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRF7RZInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-12-2021
06:54:15
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRF7RZInitial Entry
5.d
Date Location User Value Reason
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492889
Page 105 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Jan-12-2021
06:54:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BS331XInitial Entry
5.d Sample ID
Date Location User Value Reason
Jan-12-2021
06:54:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BS331XInitial Entry
5.e
Date Location User Value Reason
Jan-12-2021
06:54:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BS331YInitial Entry
5.e Sample ID
Date Location User Value Reason
Jan-12-2021
06:54:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BS331YInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492890
Page 106 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-12-2021 06:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-12-2021 06:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-12-2021
06:55:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-12-2021
06:54:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
correct as
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492891
Page 107 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
appropriate.
Jan-12-2021
06:54:56
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
5.a
Date Location User Value Reason
Jan-12-2021
06:55:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRL2LGInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-12-2021
06:55:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRL2LGInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492892
Page 108 of 177
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-12-2021
06:55:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-12-2021 06:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-12-2021 06:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-12-2021
06:55:32
(UTC-05:00)
Eastern Time (US &ACV0PF
EINFP60
00 Data Entry:
Jan/11/2021 12:48Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492893
Page 109 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Canada)
5. Anatomical Location:
Date Location User Value Reason
Jan-12-2021 06:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-12-2021
06:55:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-12-2021 06:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-12-2021 06:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492894
Page 110 of 177
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jan-12-2021
06:55:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492895
Page 111 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Jan-12-2021
06:55:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES - REACTOGENICIT
Y E-DIARY COLLECTE
D FOR THIS SUBJECTInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492896
Page 112 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-01-2021
15:57:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/1/2021Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492897
Page 113 of 177
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
E
R
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Feb-01-2021
15:57:30ACV0PF
EINFP60Data Entry:
FEVERInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492898
Page 114 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00)
Eastern Time (US &
Canada)00 
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
G
UE
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:N
OInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492899
Page 115 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 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
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492900
Page 116 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 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
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
S
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was co
mpleted?:N
OInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492901
Page 117 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 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
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492902
Page 118 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 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
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492903
Page 119 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 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
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSC
LE PAI
NInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492904
Page 120 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:NO
2.g Symptom:
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED M
USCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW
OR WInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492905
Page 121 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Eastern Time (US &
Canada)ORSE
NED J
OINT P
AIN
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:NO
2.h Symptom:
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED J
OINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492906
Page 122 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-01-2021
15:57:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reacti
on::RE
DN
ES
S
Were injection site r
eactions present on t
he last day the Subj
ect Diary was compl
eted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492907
Page 123 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 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
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site React
ion::SW
EL
LIN
G
Were injection site
reactions present o
n the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492908
Page 124 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Injection Site Reaction:
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 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
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Re
action::PAIN
AT IN
JECTI
ON SI
TEInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492909
Page 125 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Were injection sit
e reactions prese
nt on the last day
the Subject Diary
was completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
PAIN AT INJECTION SIT
EInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Feb-01-2021
15:57:30
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492910
Page 126 of 177
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date:
Date Location User Value Reason
Feb-01-2021
15:58:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Feb/1/2021Initial Entry
2.a
Date Location User Value Reason
Feb-01-2021
15:58:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Record Identi
fier::1
Temperature: 96.3
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Feb-01-2021
15:58:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
1Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492911
Page 127 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.a Temperature:
Date Location User Value Reason
Feb-02-2021
02:52:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Feb-01-2021
15:59:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered NCS PER PI
Feb-01-2021
15:58:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Opened Temperature
96.3 F is outside
of Normal
Range 97 - 99.5
F.
Feb-01-2021
15:58:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
96.3Initial Entry
2.a Unit:
Date Location User Value Reason
Feb-01-2021
15:58:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
FInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492912
Page 128 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.a Temperature Location:
Date Location User Value Reason
Feb-01-2021
15:58:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
ORAL CAVITYInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492913
Page 129 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-01-2021
15:58:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-01-2021
15:58:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-01-2021
15:59:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-01-2021
15:58:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492914
Page 130 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
review and
correct as
appropriate.
Feb-01-2021
15:58:49
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Feb/1/2021Initial Entry
5.a
Date Location User Value Reason
Feb-01-2021
15:59:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BRF83RInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-01-2021
15:59:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
BRF83RInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492915
Page 131 of 177
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-01-2021
15:59:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-01-2021
15:59:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Feb-01-2021
15:59:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-01-2021
15:59:57ACV0PF
EINFP60Data Entry:
Feb/1/2021 11:21Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492916
Page 132 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00)
Eastern Time (US &
Canada)00 
5. Anatomical Location:
Date Location User Value Reason
Feb-01-2021
15:59:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-01-2021
15:59:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-01-2021
15:59:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492917
Page 133 of 177
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Feb-01-2021
15:59:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIE
D OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-01-2021
15:59:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492918
Page 134 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021
01:27:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Mar-11-2021
15:30:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered done
Mar-03-2021
02:14:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened DM: The
treatment period
is defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination.
Please complete
treatment
disposition CRF
and update date
of EOT to match
date of visit at
visit 3.
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0492919
Page 135 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-01-2021
14:32:06
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Mar/1/2021Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0492920
Page 136 of 177
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
FEVERInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492921
Page 137 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492922
Page 138 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.b Symptom:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 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
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492923
Page 139 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.c Symptom:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 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
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492924
Page 140 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.d Symptom:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 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
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492925
Page 141 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.e Symptom:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 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
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492926
Page 142 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.f Symptom:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 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
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492927
Page 143 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.g Symptom:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED MU
SCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed
?:NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492928
Page 144 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
2.h Symptom:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
LEFTInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492929
Page 145 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.a
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 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
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.b
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492930
Page 146 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Injection Site Reactio
n::SW
ELL
ING
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 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
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Mar-01-2021 ACV0PF Data Entry: Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0492931
Page 147 of 177
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY -
SYMPTOM RESOLVED DATES - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)EINFP60
00 Injection Site React
ion::PAIN
AT INJ
ECTI
ON SI
TE
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 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
Mar-01-2021
14:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492932
Page 148 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-01-2021
14:33:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-01-2021
14:33:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-01-2021
14:33:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-01-2021
14:33:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492933
Page 149 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
correct as
appropriate.
Mar-01-2021
14:33:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Mar/1/2021Initial Entry
5.a
Date Location User Value Reason
Mar-01-2021
14:33:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BPZMLLInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-01-2021
14:33:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BPZMLLInitial Entry
5.b
Date Location User Value Reason
Mar-01-2021
14:33:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BPZMLMInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492934
Page 150 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Mar-01-2021
14:33:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BPZMLMInitial Entry
5.c
Date Location User Value Reason
Mar-01-2021
14:33:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BPZMLNInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-01-2021
14:33:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BPZMLNInitial Entry
5.d
Date Location User Value Reason
Mar-01-2021
14:33:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BSC2X4Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492935
Page 151 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.d Sample ID
Date Location User Value Reason
Mar-01-2021
14:33:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BSC2X4Initial Entry
5.e
Date Location User Value Reason
Mar-01-2021
14:33:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BSC2X5Initial Entry
5.e Sample ID
Date Location User Value Reason
Mar-01-2021
14:33:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BSC2X5Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492936
Page 152 of 177
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-26-2021
14:22:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Query 1: Answered added
Aug-17-2021
14:02:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Query 1: Reissued:Opened It may not meet
the requirement
for reporting as
SAE. However,
it should be
reported as AE.
Please kindly
review AE/SAE
reporting criteria
and add to
source and EDC.
Aug-16-2021
08:14:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Query 1: Answered Per source -
appendicitis, less
than 24 hours
does not met
requirements for
reporting at this
time
Aug-13-2021
16:16:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Query 1: Opened Appendicitis was
reported at V4.
Please add to AE
log and consider
to report as SAE.
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492937
Page 153 of 177
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Aug-03-2021
09:35:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Aug/2/2021Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492938
Page 154 of 177
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-03-2021
09:36:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-03-2021
09:36:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-03-2021
09:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-03-2021
09:36:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492939
Page 155 of 177
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
correct as
appropriate.
Aug-03-2021
09:36:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Date of Collection:
Aug/2/2021Initial Entry
5.a
Date Location User Value Reason
Aug-03-2021
09:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BLZK00Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-03-2021
09:36:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BLZK00Initial Entry
5.b
Date Location User Value Reason
Aug-03-2021
09:36:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BLX1NXInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492940
Page 156 of 177
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
5.b Sample ID
Date Location User Value Reason
Aug-03-2021
09:36:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BLX1NXInitial Entry
5.c
Date Location User Value Reason
Aug-03-2021
09:37:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Sample ID: BLX1NYInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-03-2021
09:37:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
BLX1NYInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492941
Page 157 of 177
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-11-2021
15:25:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Mar/1/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-11-2021
15:25:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Mar-11-2021
15:25:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492942
Page 158 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Visit
Date Location User Value Reason
May-17-2021
12:48:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Deleted New
Information
May-17-2021
12:48:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
May/13/2021New
Information
May-12-2021
00:55:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Candidate Site to update
the date and re
vaccination
confirmation
CRF. Please
check audit trail
and close this
candidate query
once the updates
are done.
Feb-27-2021
17:07:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Julie Mooney Data Entry:
Feb/27/2021Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2022-5812-0492943
Page 159 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
May-17-2021
12:48:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 3: Deleted Close Auto
Query
May-17-2021
12:48:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 3: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP visit.
Please complete
this date.
May-17-2021
12:48:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Deleted New Information
May-17-2021
12:48:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Participant is willing to ret
urn for Vaccination 3
Participant is:New Information
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0492944
Page 160 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
eligible and NOT confir
med to have received o
nly placebo at Vaccinati
on 1/2
May-12-2021
00:56:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 2: Candidate Site to update
the date and re
vaccination
confirmation
CRF. Please
check audit trail
and close this
candidate query
once the updates
are done.
May-12-2021
00:55:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed error
May-12-2021
00:55:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened Site to update
the date and re
vaccination
confirmation
CRF. Please
check audit trail
and close this
candidate query
once the updates
are done.
Feb-27-2021
17:07:39ACV0PF
EINFP60Julie Mooney Data Entry:
Participant is NOT willingInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0492945
Page 161 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00)
Eastern Time (US &
Canada)00  to return for Vaccination 3
OR otherwise not eligible
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492946
Page 162 of 177
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-16-2021
15:03:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not DoneInitial Entry
Mar-12-2021
11:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry: Transcription
Error
Mar-10-2021
15:15:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Mar/1/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-16-2021
15:03:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
Mar-12-2021
11:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry: Transcription
Error
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492947
Page 163 of 177
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Mar-10-2021
15:15:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Mar-16-2021
15:03:42
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
Not DoneInitial Entry
Mar-12-2021
14:15:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Mar-12-2021
11:05:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Answered Transcription
Error
Mar-12-2021
11:05:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry: Transcription
Error
Mar-11-2021
09:42:52
(UTC-05:00)ACV0PF
EINFP60
00 Query 1: Opened DM Q: Status is
entered as
COMPLETED,
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0492948
Page 164 of 177
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Eastern Time (US &
Canada)however per
eCCG,
COMPLETED
status should be
selected if
patient has
completed all
protocol defined
safety follow up
visits. Please
verify and
update the data
accordingly, else
clarify.
Mar-10-2021
15:15:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-16-2021
15:03:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Not DoneInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492949
Page 165 of 177
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
Date Location User Value Reason
Aug-26-2021
13:38:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492950
Page 166 of 177
***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, Queries
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Category:
Date Location User Value Reason
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Aug-31-2021
05:39:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Oyeniyi
DiyaQuery 2: Opened MM: Please
provide findings
during
appendectomy if
available
Aug-31-2021
05:33:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Oyeniyi
DiyaQuery 1: Opened MM: Please
provide
information
regarding
presenting
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2022-5812-0492951
Page 167 of 177
***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, Queries
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
symptoms and
investigations.
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
AppendicitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Jun/28/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NO
End Date Time:
Jun/29/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
2Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492952
Page 168 of 177
***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, Queries
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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
Aug-27-2021
07:37:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto query
(autoquery)Query 1: Candidate For AE
Appendicitis:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event resulInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492953
Page 169 of 177
***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, Queries
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
t in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
NO
Did this serious event resul
t in persistent or significant
disability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious event
YES
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
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492954
Page 170 of 177
***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, Queries
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
9. Is this event related to study treatment:
Date Location User Value Reason
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Aug-31-2021
05:35:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Oyeniyi
DiyaQuery 1: Opened MM: Please
confirm no
medication was
given prior and
after surgery
Aug-26-2021
13:38:46ACV0PF
EINFP60Data Entry:
NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492955
Page 171 of 177
***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, Queries
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
(UTC-05:00) Eastern
Time (US & Canada)00 
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Aug-31-2021
05:36:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Oyeniyi
DiyaQuery 1: Opened MM: Please
consider
including
information on
histology report
if available
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Aug-26-2021
13:38:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
NOInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492956
Page 172 of 177
***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, Queries
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Aug-27-2021
07:37:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
202101108305Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2022-5812-0492957
Page 173 of 177
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
May-17-2021
12:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
May/17/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
May-17-2021
12:48:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492958
Page 174 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-12-2021
11:05:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
FOLLOW-UPTranscription
Error
Mar-12-2021
00:12:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Closed Response
satisfies query
Mar-11-2021
15:29:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Answered done
Mar-11-2021
15:25:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
COMPLETEDInitial Entry
Mar-11-2021
07:30:46
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 Query 1: Opened DM: Kindly
review and
complete
‘Casebook
signature' form
at this visit.
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2022-5812-0492959
Page 175 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Thank you.
Mar-10-2021
15:15:03
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
COMPLETEDInitial Entry
Jan-12-2021
06:52:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMI
ZEDInitial Entry
Jan-12-2021
06:51:36
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-12-2021
11:05:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Mar/1/2021Transcription
Error
Mar-12-2021
11:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Mar/1/2021Transcription
Error
Mar-11-2021
15:25:41
(UTC-05:00) EasternACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Mar/1/2021Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492960
Page 176 of 177
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
Time (US & Canada)
Mar-10-2021
15:15:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Mar/1/2021Initial Entry
Jan-12-2021 06:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Jan/11/2021Initial Entry
Jan-12-2021 06:51:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 auto calc
(autocalc)Data Entry:
Jan/11/2021Initial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
FDA-CBER-2022-5812-0492961
Page 177 of 177
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051449 Subject Initials: ---
Generated By: Generated Time (GMT): 10-Nov-2021 20:44
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1. Casebook Signature
Date Location User Value Reason
Mar-11-2021
15:29:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PF
EINFP60
00 Data Entry:
Click Here to EnableInitial Entry
090177e19891a036\Final\Final On: 11-Nov-2021 01:20 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2022-5812-0492962