125742 S1 M5 CRF c4591001 1248 12481163

Document text

Page 1 of 195
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0829999
Page 2 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/14/2020
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830000
Page 3 of 195
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12481163]
2.Birth Date: /1946
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830001
Page 4 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830002
Page 5 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830003
Page 6 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830004
Page 7 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Seasonal Allergy]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[High Cholesterol]
Start Date: UNK/UNK/2015
Ongoing: YES
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830005
Page 8 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
2.Weight: [56.2]
3.Unit: kg
4.Height: [158.5]
5.Unit: cm
6.Body Mass Index: [22.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830006
Page 9 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/14/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830007
Page 10 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/14/2020
2.Randomization Number: [259267]
3.Randomization Group: [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830008
Page 11 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8LG0]
5.bSample ID [BMNXZB]
5.cSample ID [BMNXZC]
5.dSample ID [BMNXZD]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830009
Page 12 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8LFW]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830010
Page 13 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/14/2020 16:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830011
Page 14 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830012
Page 15 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/5/2020
2.Erroneous Visit
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830013
Page 16 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830014
Page 17 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/5/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830015
Page 18 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/5/2020
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW1B1]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830016
Page 19 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: Oct/5/2020 14:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830017
Page 20 of 195
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830018
Page 21 of 195
***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, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or sample
was not collected according to protocol,
please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830019
Page 22 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830020
Page 23 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830021
Page 24 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830022
Page 25 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830023
Page 26 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830024
Page 27 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830025
Page 28 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830026
Page 29 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830027
Page 30 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830028
Page 31 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830029
Page 32 of 195
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Jan/5/2021
2.Phase of Disposition: VACCINATION
3.Status: PROTOCOL DEVIATION
4.Specify Status: [crossover, revaccination
V3 not performed/missed by the participant]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830030
Page 33 of 195
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :// Comments
2.Phase of Disposition: Comments
3.Status: Comments
4.Specify Status: [ ] Comments
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830031
Page 34 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830032
Page 35 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830033
Page 36 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Headache (R sided headache aro
und R eye) Oct/3/2020 UNK:
UNK NO
End Date Time:
Oct/5/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Brain abscess  Oct/10/2020 UNK:
UNK YES  Repeating
Pages
 3.ADVERSE EV
ENT 3  Sinusitis  Oct/10/2020 UNK:
UNK YES  Repeating
Pages
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830034
Page 37 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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)[Headache (R sided headache around R eye)]
4.Start Date Time: Oct/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/5/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Headache]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830035
Page 38 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830036
Page 39 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Brain abscess]
4.Start Date Time: Oct/10/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
YES
Is this serious event life threatening?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Sinusitis / blocked sinuses]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830037
Page 40 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020403755]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830038
Page 41 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Sinusitis]
4.Start Date Time: Oct/10/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to prevent
above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Sinusitis/Blocked Sinuses]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this adverse
event?:RECOVERING/RESOLVING
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830039
Page 42 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
14.Did the adverse event cause the subject
to be discontinued from the study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830040
Page 43 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yMedication Erro
rStart Dat
eIs the medication error Still Ongoi
ngStudy Medication Errors Acti
onForm Instance
 1.          Repeating Pages
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830041
Page 44 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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[ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830042
Page 45 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Iden
tifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830043
Page 46 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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: //
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830044
Page 47 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830045
Page 48 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830046
Page 49 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830047
Page 50 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830048
Page 51 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830049
Page 52 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830050
Page 53 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830051
Page 54 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830052
Page 55 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830053
Page 56 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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?
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830054
Page 57 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830055
Page 58 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830056
Page 59 of 195
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830057
Page 60 of 195
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 per other protocol allowance(s) and confirmed to have received only placebo at
Vaccination 1/2
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830058
Page 61 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/9/2021
2.Erroneous Visit
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830059
Page 62 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/9/2021
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830060
Page 63 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830061
Page 64 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/9/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830062
Page 65 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/9/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830063
Page 66 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/9/2021
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 [BPW1J6]
5.bSample ID [BS7Z05]
5.cSample ID [BS7Z06]
5.dSample ID [BS7Z07]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830064
Page 67 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/9/2021
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 [BPW1J2]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830065
Page 68 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/9/2021 13:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830066
Page 69 of 195
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830067
Page 70 of 195
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830068
Page 71 of 195
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830069
Page 72 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830070
Page 73 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/28/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830071
Page 74 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [BRFYRJ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830072
Page 75 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/28/2021 12:05
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830073
Page 76 of 195
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/26/2021 Comments
2.Erroneous Visit
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830074
Page 77 of 195
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/26/2021
3.Comments: [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830075
Page 78 of 195
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830076
Page 79 of 195
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830077
Page 80 of 195
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830078
Page 81 of 195
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830079
Page 82 of 195
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Form Comments
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Feb/26/2021 Comments
2.Phase of Disposition: OPEN LABEL TREATMENT Comments
3.Status: COMPLETED Comments
4.Specify Status: [ ] Comments
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830080
Page 83 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Jan/5/2021
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830081
Page 84 of 195
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830082
Page 85 of 195
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830083
Page 86 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-15-2020 13:57:50 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830084
Page 87 of 195
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-25-2021 14:21:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830085
Page 88 of 195
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-25-2021 14:21:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830086
Page 89 of 195
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Feb-25-2021 14:21:42 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830087
Page 90 of 195
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-25-2021 14:22:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830088
Page 91 of 195
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-25-2021 14:22:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830089
Page 92 of 195
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Feb-25-2021 14:22:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830090
Page 93 of 195
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Feb-25-2021 14:22:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830091
Page 94 of 195
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Feb-25-2021 14:22:19 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830092
Page 95 of 195
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormMar-10-2021 16:47:21 (UTC-05:00) Eastern Time
(US & Canada)
FormFeb-24-2021 13:55:21 (UTC-05:00) Eastern Time
(US & Canada)participant did not complete the treatment period due
to starting the crossover study (revaccination)
Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830093
Page 96 of 195
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Mar-10-2021 16:47:21 (UTC-05:00) Eastern Time
(US & Canada)
1Feb-24-2021 13:55:21 (UTC-05:00) Eastern Time
(US & Canada)participant did not complete the treatment period due
to starting the crossover study (revaccination)
Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830094
Page 97 of 195
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Mar-10-2021 16:47:21 (UTC-05:00) Eastern Time
(US & Canada)
2Feb-24-2021 13:55:21 (UTC-05:00) Eastern Time
(US & Canada)participant did not complete the treatment period due
to starting the crossover study (revaccination)
Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830095
Page 98 of 195
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Mar-10-2021 16:47:21 (UTC-05:00) Eastern Time
(US & Canada)
3Feb-24-2021 13:55:21 (UTC-05:00) Eastern Time
(US & Canada)participant did not complete the treatment period due
to starting the crossover study (revaccination)
Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830096
Page 99 of 195
***Confidential***
Header Text: c4591001
Visit: Follow-Up Form: DISPOSITION - FOLLOW-UP - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Incomplete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Mar-10-2021 16:47:21 (UTC-05:00) Eastern Time
(US & Canada)
4Feb-24-2021 13:55:21 (UTC-05:00) Eastern Time
(US & Canada)participant did not complete the treatment period due
to starting the crossover study (revaccination)
Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830097
Page 100 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-12-2021 13:15:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830098
Page 101 of 195
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormFeb-24-2021 13:58:46 (UTC-05:00) Eastern Time
(US & Canada)participant did not complete the treatment period due
to starting the crossover study (revaccination)
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830099
Page 102 of 195
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Feb-24-2021 13:56:34 (UTC-05:00) Eastern Time
(US & Canada)participant did not complete the treatment period due
to starting the crossover study (revaccination)
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830100
Page 103 of 195
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormMar-10-2021 16:48:16 (UTC-05:00) Eastern Time
(US & Canada)
FormFeb-24-2021 13:54:40 (UTC-05:00) Eastern Time
(US & Canada)participant did not complete the treatment period due
to starting the crossover study (revaccination)
Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830101
Page 104 of 195
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
1Mar-10-2021 16:48:16 (UTC-05:00) Eastern Time
(US & Canada)
1Feb-24-2021 13:54:40 (UTC-05:00) Eastern Time
(US & Canada)participant did not complete the treatment period due
to starting the crossover study (revaccination)
Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830102
Page 105 of 195
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
2Mar-10-2021 16:48:16 (UTC-05:00) Eastern Time
(US & Canada)
2Feb-24-2021 13:54:40 (UTC-05:00) Eastern Time
(US & Canada)participant did not complete the treatment period due
to starting the crossover study (revaccination)
Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830103
Page 106 of 195
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
3Mar-10-2021 16:48:16 (UTC-05:00) Eastern Time
(US & Canada)
3Feb-24-2021 13:54:40 (UTC-05:00) Eastern Time
(US & Canada)participant did not complete the treatment period due
to starting the crossover study (revaccination)
Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830104
Page 107 of 195
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT Form: DISPOSITION - TREATMENT - Comments
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
4Mar-10-2021 16:48:16 (UTC-05:00) Eastern Time
(US & Canada)
4Feb-24-2021 13:54:40 (UTC-05:00) Eastern Time
(US & Canada)participant did not complete the treatment period due
to starting the crossover study (revaccination)
Not Done
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830105
Page 108 of 195
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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 Jan-12-2021 13:14:27 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Mohamed
Al-ibrahim Approved Nov-10-2020 12:10:56 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MohamedAl-ibrahim, 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.
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830106
Page 109 of 195
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-15-2020 13:56:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-15-2020 13:56:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830107
Page 110 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-15-2020 13:56:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/14/2020Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830108
Page 111 of 195
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-15-2020 13:56:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12481163Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-15-2020 13:56:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1946Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-15-2020 13:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-15-2020 13:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-15-2020 13:56:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830109
Page 112 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-15-2020 13:57:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830110
Page 113 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-15-2020 13:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-15-2020 13:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-15-2020 13:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830111
Page 114 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020 13:19:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Luis Monsalve Data Entry:
Line/MH Number: 1
Medical History Ter
m:Seasonal Aller
gy
Start Date: UNK/UNK/20
15
Ongoing: YESTranscription Error
Sep-15-2020 13:58:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Seasonal
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:58:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
10:34:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Clo
sedResponse satisfies
query
Sep-16-2020
16:02:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 3: Clo
sedDiscrepancy has been
closed.
Sep-16-2020
13:19:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query (autoquery) Query 3: An
sweredTranscription Error
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830112
Page 115 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-16-2020
13:19:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query (autoquery) Query 2: An
sweredTranscription Error
Sep-16-2020
13:19:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Luis Monsalve Data Entry:
Seasonal All
ergyTranscription Error
Sep-16-2020
06:46:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 3: Op
enedClarify SEASONAL
as follows...Term
appears
truncated/incomplete.
Please clarify the
medical diagnosis
being reported. If
reporting
SEASONAL
ALLERGY or
SEASONAL
ALLERGIC
RHINITIS or
SEASONAL
AFFECTIVE
DISORDER or Other.
Please edit
appropriately.
Otherwise, clarify.
Thank you.
Sep-16-2020
06:41:03
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 2: Op
enedClarify SEASONAL
as follows...Term
appears
truncated/incomplete.
Please clarify the
medical diagnosis
being reported. If
reporting
SEASONAL
ALLERGY or
SEASONAL
ALLERGIC
RHINITIS or
SEASONAL
AFFECTIVE
DISORDER or Other.
Please edit
appropriately.
Otherwise, clarify.
Thank you.
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830113
Page 116 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-16-2020
05:38:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Clo
sedDiscrepancy has been
closed.
Sep-15-2020
15:08:08
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Op
enedClarify SEASONAL
as follows...Term
appears
truncated/incomplete.
Please clarify the
medical diagnosis
being reported. If
reporting
SEASONAL
ALLERGY or
SEASONAL
ALLERGIC
RHINITIS or
SEASONAL
AFFECTIVE
DISORDER or Other.
Please edit
appropriately.
Otherwise, clarify.
Thank you.
Sep-15-2020
13:58:50
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SeasonalInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-15-2020 13:58:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-15-2020 13:58:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830114
Page 117 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-15-2020 13:59:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:High Cholester
ol
Start Date: UNK/UNK/201
5
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-15-2020 13:59:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 13:59:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
High CholesterolInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-15-2020 13:59:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-15-2020 13:59:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830115
Page 118 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020 14:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-15-2020 14:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
56.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-15-2020 14:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-15-2020 14:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
158.5Initial Entry
5. Unit:
Date Location User Value Reason
Sep-15-2020 14:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-15-2020 14:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22.4Initial Entry
7.a
Date Location User Value Reason
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830116
Page 119 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-15-2020 14:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.6
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-15-2020 14:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-15-2020 14:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-15-2020 14:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-15-2020 14:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830117
Page 120 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-15-2020 14:00:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-15-2020 14:00:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-15-2020 14:00:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-15-2020 14:00:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-15-2020 14:00:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-15-2020 14:00:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830118
Page 121 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
6.a Sponsor ID:
Date Location User Value Reason
Sep-15-2020 14:00:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-15-2020 14:00:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-15-2020 14:00:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830119
Page 122 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-15-2020 14:00:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-15-2020 14:00:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
259267Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830120
Page 123 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 14:00:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 14:00:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-15-2020 14:00:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 14:00:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-15-2020 14:00:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020 14:00:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8LG0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-15-2020 14:00:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP8LG0Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830121
Page 124 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b
Date Location User Value Reason
Sep-15-2020 14:01:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNXZBInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-15-2020 14:01:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BMNXZBInitial Entry
5.c
Date Location User Value Reason
Sep-15-2020 14:01:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNXZCInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-15-2020 14:01:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BMNXZCInitial Entry
5.d
Date Location User Value Reason
Sep-15-2020 14:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNXZDInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-15-2020 14:01:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BMNXZDInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830122
Page 125 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 14:01:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 14:01:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-15-2020 14:02:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 14:01:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Sep-15-2020 14:01:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020 14:02:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8LFWInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-15-2020 14:02:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP8LFWInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830123
Page 126 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-15-2020 14:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020 14:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020 14:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-15-2020 14:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020 16:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020 14:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-15-2020 14:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830124
Page 127 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-15-2020 14:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-15-2020 14:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-15-2020 14:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830125
Page 128 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-15-2020 14:02:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830126
Page 129 of 195
***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, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021 05:41:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Feb-23-2021 13:24:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Visit 3 1mo f/u never
occurred. Participant missed
her appt. Has since been
unblinded and vaccinated in
the VTO group.
Feb-22-2021 17:38:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Subject should have had
V3_MONTH1_POSTVAX2_L
visit around the 5th of
November 2020. Please
confirm if this visit did or did
not occur and consider
updating dates/CRFs as
necessary or as applicable (e.g.
End of Treatment, etc.).
Oct-06-2020 12:44:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830127
Page 130 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-06-2020 12:44:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
2.a
Date Location User Value Reason
Oct-06-2020 12:44:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 37.0
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-06-2020 12:44:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-06-2020 12:44:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-06-2020 12:44:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-06-2020 12:44:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830128
Page 131 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-06-2020 12:45:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-06-2020 12:45:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-06-2020 12:45:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-06-2020 12:45:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-06-2020 12:45:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-06-2020 12:45:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830129
Page 132 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
6.a Sponsor ID:
Date Location User Value Reason
Oct-06-2020 12:45:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-06-2020 12:45:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-06-2020 12:45:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830130
Page 133 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 12:45:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 12:45:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 12:45:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-06-2020 12:45:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Oct-06-2020 12:45:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/5/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 12:45:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPW1B1Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 12:45:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPW1B1Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830131
Page 134 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-06-2020 12:46:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-06-2020 12:46:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-06-2020 12:46:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-06-2020 12:46:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020 14:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-06-2020 12:46:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-06-2020 12:46:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830132
Page 135 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-06-2020 12:46:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-06-2020 12:46:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSER
VATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-06-2020 12:46:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830133
Page 136 of 195
***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, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021 14:21:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Feb-25-2021 14:21:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830134
Page 137 of 195
***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, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-25-2021 14:22:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-25-2021 14:22:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-25-2021 14:22:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-25-2021 14:22:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830135
Page 138 of 195
***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, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-11-2021 16:34:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Closed Response satisfies
query
Mar-10-2021 17:55:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered This has been done
Mar-08-2021 16:38:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Reissued:Opened CLINQUERY: Please
also review entry in
"specify status" field
per query ie clarify V3
was not performed/not
attended
Mar-08-2021 15:12:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered this has been done
Mar-08-2021 14:53:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Reissued:Opened CLINQUERY: Thanks
for clarifying, since the
v3 in November was
missed, please capture
this page as status
'PROTOCOL
DEVIATION' and
clarify in specify status
field non-attendance of
V3
Mar-04-2021 12:42:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered Participant missed her
V3 appt but was being
actively pursued. Has
since been unblinded
and vaccinated in the
VTO group.
Mar-02-2021 16:49:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Opened CLINQUERY: Visit 3
was due in November.
Please review reason
why V3 did not take
place. EOT Date and
Status selection should
match to lack of V3 at
that timepoint.
Mar-02-2021 02:40:21
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830136
Page 139 of 195
***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, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada)
Mar-01-2021 14:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Mar-01-2021 14:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/5/2021Initial Entry
Feb-24-2021 13:36:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Erica Weaver Query 1: Opened Please enter this form
in relation to the
treatment period - as
defined as Vaccination
1 through Visit 3.
2. Phase of Disposition:
Date Location User Value Reason
Mar-01-2021 14:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Mar-08-2021 15:11:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PROTOCOL DEVIATIONparticipant missed
visit 3
Mar-01-2021 14:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-10-2021 17:55:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
crossover, revaccination
V3 not performed/missed by the partici
pantNew Information
Mar-01-2021 14:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
crossover, revaccinationInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830137
Page 140 of 195
***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: Incomplete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-11-2021 13:52:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-10-2021 16:47:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/26/2021Initial Entry
Mar-10-2021 16:47:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-24-2021 13:55:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-11-2021 13:52:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Mar-10-2021 16:47:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Mar-10-2021 16:47:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-24-2021 13:55:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Status:
Date Location User Value Reason
Mar-11-2021 13:53:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-10-2021 16:47:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830138
Page 141 of 195
***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: Incomplete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Mar-10-2021 16:47:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-24-2021 13:55:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-10-2021 16:47:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-24-2021 13:55:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830139
Page 142 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830140
Page 143 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830141
Page 144 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830142
Page 145 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Headache (R sided headache around R
eye)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/5/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830143
Page 146 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-17-2020 14:45:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
HeadacheTranscription Error
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830144
Page 147 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada)
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-17-2020 14:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830145
Page 148 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-03-2021
07:36:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Giselle Castillo Query 3: Closed Thanks for confirming.
Clinical will continue
to FU at a later date.
Feb-24-2021
16:15:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 3: Answe
redNo results/discharge
summary provided at
this time.
Nov-23-2020
13:14:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Giselle Castillo Query 3: Opene
dPer narrative, "A
culture was performed
with positive results,
but organism was
unknown". Kindly
confirm if results were
provided or discharge
summary is available.
Thank you.
Oct-24-2020
10:17:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-23-2020
13:10:51
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Closed Discrepancy has been
closed.
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830146
Page 149 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Eastern Time (US
& Canada)
Oct-23-2020
11:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answe
redNew Information
Oct-23-2020
11:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answe
redNew Information
Oct-23-2020
11:22:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Brain abscessNew Information
Oct-19-2020
07:24:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opene
dSAE RECON:
AER#2020403755,the
term was reported as
'brain abscess' in
Safety database while
recorded as Brain
abscess as a
complication of
sinusitis in AE CRF.
Please confirm correct
term.If safety update is
required, please submit
a follow-up form
Oct-17-2020
16:48:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: Opene
dMultiple concepts in
the term BRAIN
ABSCESS AS A
COMPLICATION OF
SINUSITIS. Split the
term into BRAIN
ABSCESS and
SINUSITIS and report
as 2 separate entries.
Thank you.
Oct-17-2020
14:47:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Brain abscess as
a complication o
f sinusitisInitial Entry
4. Start Date Time:
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830147
Page 150 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/10/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 13:52:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-10-2021 16:47:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Disposition Follow-up
form is completed and
this Adverse Event is
still ongoing. Please
review and update as
appropriate.
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-03-2021 07:36:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 6: Closed Thanks for confirming.
Clinical will continue
to FU at a later date.
Feb-24-2021 16:28:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 6: Answered No records received to
date, unknown if
COVID testing
performed in hospital.
Nasal swab collected at
Visit 101 in Jan2021.
Will send updated
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830148
Page 151 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
form.
Nov-23-2020 13:18:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 6: Opened As per the request of
our Data Monitoring
Committee, please
include in the
initial/follow-up SAE
form whether COVID
testing was conducted –
yes/no including not
available/not
performed. If COVID
testing was performed,
include the results.
Thank you.
Nov-02-2020 09:39:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Oct-31-2020 12:04:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Oct-31-2020 06:21:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-30-2020 14:30:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Closed Close Auto Query
Oct-30-2020 14:30:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with c
ongenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prol
ong hospitalization?
YES
Did this serious event result in persist
ent or significant disability/incapacit
y?
YESTranscription Error
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830149
Page 152 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Is this serious event life threatening?
YES
Other medically important serious ev
ent
NO
Oct-30-2020 14:29:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Opened Is this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria is
missing. Please review
and update as
appropriate.
Oct-30-2020 14:29:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered Transcription Error
Oct-30-2020 14:29:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with c
ongenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prol
ong hospitalization?
YES
Is this serious event life threatening?
YES
Other medically important serious ev
ent
NOTranscription Error
Oct-30-2020 13:53:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Opened Seriousness criteria
should be evaluated by
the investigator. If
medically important
criterion was met,
please submit a
follow-up report. Else,
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830150
Page 153 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
update CRF.
Oct-30-2020 12:07:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Answered As per SAE Report
form, subject has
"surgical drainage of
the brain abscess."
Does this constitute
"medically important"?
Oct-30-2020 12:03:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Opened Initial SAE report only
indicates
hospitalization and life
threatening as criteria.
Please confirm if this
AE met criterion "other
medically important
serious event." If
criterion was met,
please submit a
follow-up report. Else,
update CRF.
Oct-30-2020 08:40:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered Updated
Oct-30-2020 08:39:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Oct-30-2020 08:39:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with c
ongenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prol
ong hospitalization?
YES
Is this serious event life threatening?
YES
Other medically important serious ev
ent
YESTranscription Error
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830151
Page 154 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-29-2020 14:37:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu
R Query 3: Opened Please answer all
seriousness criteria
with “Yes” or “No
response. Thank you.
Oct-19-2020 07:23:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria is
missing. Please review
and update as
appropriate.
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Brain abscess
as a complication of
sinusitis: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with c
ongenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prol
ong hospitalization?
YES
Is this serious event life threatening?
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830152
Page 155 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
Sinusitis / blocked sinusesInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-31-2020 10:51:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Oct-31-2020 07:30:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Oct-30-2020 08:39:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Initial Entry
Oct-30-2020 08:39:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Oct-30-2020 08:39:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
Oct-20-2020 06:04:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2020403755
,action taken was reported
as NOT APPLICABLE in
in Safety while missing in
AE CRF.Please confirm. If
safety update is required,
please submit a follow up
form
Oct-19-2020 07:08:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response for Data
item#10 and 14 are
missing. Kindly review and
update.
11. Was a Concomitant Medication given?
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830153
Page 156 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830154
Page 157 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-17-2020 14:47:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-30-2020 08:39:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-19-2020 07:23:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020403755Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830155
Page 158 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SinusitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/10/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 13:52:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-10-2021 16:47:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is still
ongoing. Please
review and update as
appropriate.
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830156
Page 159 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
6. Toxicity Grade:
Date Location User Value Reason
Nov-03-2020 12:49:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
Nov-01-2020 08:54:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Entered in error. PI to
review.
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-05-2020 02:40:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 7: Closed Response satisfies
query
Nov-04-2020 13:07:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 7: Answered Transcription Error
Nov-04-2020 13:07:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Deleted Close Auto Query
Nov-04-2020 13:07:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Nov-04-2020 07:25:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 7: Opened SAE RECON: AER#
Sinusitis event updated
back to serious. Per
previous confirmation,
sinusitis event is an
AE. If this event is
indeed not serious,
downgrade the event
on AE CRF to
No.Otherwise, please
report event to Safety
database.
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830157
Page 160 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-04-2020 03:44:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Nov-03-2020 12:49:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Candidate For AE Sinusitis :
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Nov-03-2020 12:49:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered Initial Entry
Nov-03-2020 12:49:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in dea
th?
NO
Did this serious event require or pr
olong hospitalization?
YES
Did this serious event result in per
sistent or significant disability/inca
pacity?
NO
Is this serious event life threatenin
g?
YES
Other medically important serious
event
NOInitial Entry
Nov-02-2020 09:12:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Opened DM: A response to
Item #7 "Is the adverse
event serious?" is
missing, please review
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830158
Page 161 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
and provide.
Nov-01-2020 08:54:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered Entered in error. PI to
review.
Nov-01-2020 08:54:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Entered in error. PI to
review.
Oct-31-2020 12:12:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Opened There are multiple
serious criteria in this
field. Please answer all
seriousness criteria
with “Yes” or “No
response. Thank you.
Oct-31-2020 10:52:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Oct-30-2020 11:24:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Oct-30-2020 11:24:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Oct-30-2020 10:35:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 5: Deleted Query can be
addressed internally
Oct-30-2020 10:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened SAE RECON 1: Per
previous confirmation,
sinusitis event is an
AE. If this event
isindeed not serious,
downgrade the event
on AE CRF to No
Oct-30-2020 08:41:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Candidate For AE Sinusitis :
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-30-2020 08:41:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered updated
Oct-30-2020 08:41:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered updated
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830159
Page 162 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-30-2020 08:41:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-30-2020 08:41:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in dea
th?
NO
Did this serious event require or pr
olong hospitalization?
YES
Did this serious event result in per
sistent or significant disability/inca
pacity?
NO
Is this serious event life threatenin
g?
YES
Other medically important serious
event
YESupdated
Oct-29-2020 14:38:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 4: Opened Please answer all
seriousness criteria
with “Yes” or “No
response. Thank you.
Oct-24-2020 10:21:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Opened SAE RECON:
Sinusitis (Onset
date:10Oct2020) is not
reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness
and report to Pfizer
immediately. If this
event is not serious,
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830160
Page 163 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
downgrade the event
on AE CRF
Oct-24-2020 10:20:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed internally
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria is
missing. Please review
and update as
appropriate.
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Sinusitis :
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in dea
th?
NO
Did this serious event require or pr
olong hospitalization?
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-23-2020 11:24:59 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830161
Page 164 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-05:00) Eastern Time
(US & Canada)NOT RELATED
If Not Related to study treatment(s),
this event is due to:
OTHER
If Other, specify:
Sinusitis/Blocked Sinuses
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-30-2020 08:41:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-23-2020 11:24:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-30-2020 08:41:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830162
Page 165 of 195
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-12-2021 13:14:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/5/2021Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830163
Page 166 of 195
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-21-2021 16:55:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed CRA to follow-up on
eligibility for
revaccination and
correct data entry.
Jan-21-2021 16:52:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Jan-21-2021 16:52:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible per other protocol allowan
ce(s) and confirmed to have receiv
ed only placebo at Vaccination 1/2Transcription Error
Jan-20-2021 11:10:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened Please confirm
eligibility for
revaccination. Per
source participant
would not have met
local/national
recommendations to
receive vaccine at time
of visit 101.
Jan-13-2021 13:49:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-13-2021 00:00:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened The response indicates
participant was
unblinded, however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Jan-12-2021 13:14:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response indicates
participant was
unblinded, however the
TREATMENT
UNBLINDED date is
missing in the DISP
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830164
Page 167 of 195
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
visit. Please complete
this date.
Jan-12-2021 13:14:34
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for Vac
cination 3
Participant is:
eligible per local/national recomme
ndations and confirmed to have rec
eived only placebo at Vaccination
1/2Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830165
Page 168 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 16:48:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 3: Closed EOT page added
Mar-02-2021 12:39:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Answered EOT and visit 3 forms
are completed.
Feb-11-2021 15:44:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Closed Response satisfies
query
Feb-10-2021 11:24:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered confirm Visit 3 did not
occur prior to Visit
101
Feb-09-2021 07:59:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 3: Opened CLINQUERY: Per
CRF, subject did not
attend V3 in
November. Please
complete the first EOT
page to report end of
blinded treatment
phase. Status field
selection should
reflect the reason for
no V3 completion at
scheduled timepoint
Jan-28-2021 05:11:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Opened CLINQUERY: Vax 2
completed in October.
Did any visit take
place prior to
V101/Vax 3 for visit 3
(month follow up post
vax 2)?
Jan-28-2021 05:10:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed revised
Jan-21-2021 10:09:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened CLINQUERY: Visit
101 (Vax 3) occurred
> month after V2.
Please capture also as
Visit 3. In V3, mark
'no' for samples page
and comment samples
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830166
Page 169 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
taken as part of V101.
EOT page for initial
Rx phase can then be
marked as
COMPLETED status
Jan-12-2021 13:15:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/9/2021Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0830167
Page 170 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-12-2021 13:15:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/9/2021Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830168
Page 171 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-12-2021 13:16:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/9/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-12-2021 13:16:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-12-2021 13:16:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830169
Page 172 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-12-2021 13:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-12-2021 13:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-12-2021 13:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/9/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-12-2021 13:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-12-2021 13:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Jan-12-2021 13:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830170
Page 173 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
6.a Sponsor ID:
Date Location User Value Reason
Jan-12-2021 13:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-12-2021 13:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Jan-12-2021 13:17:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830171
Page 174 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-12-2021 13:18:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-12-2021 13:18:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-12-2021 13:18:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-12-2021 13:18:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-12-2021 13:18:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/9/2021Initial Entry
5.a
Date Location User Value Reason
Jan-12-2021 13:18:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPW1J6Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-12-2021 13:18:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPW1J6Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830172
Page 175 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.b
Date Location User Value Reason
Jan-12-2021 13:19:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS7Z05Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-12-2021 13:19:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BS7Z05Initial Entry
5.c
Date Location User Value Reason
Jan-12-2021 13:19:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS7Z06Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-12-2021 13:19:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BS7Z06Initial Entry
5.d
Date Location User Value Reason
Jan-12-2021 13:19:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS7Z07Initial Entry
5.d Sample ID
Date Location User Value Reason
Jan-12-2021 13:19:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BS7Z07Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830173
Page 176 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-12-2021 13:20:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-12-2021 13:20:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-12-2021 13:20:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-12-2021 13:20:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Jan-12-2021 13:20:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/9/2021Initial Entry
5.a
Date Location User Value Reason
Jan-12-2021 13:20:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPW1J2Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-12-2021 13:20:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPW1J2Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830174
Page 177 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-12-2021 13:20:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-12-2021 13:20:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-12-2021 13:20:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-12-2021 13:20:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/9/2021 13:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-12-2021 13:20:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-12-2021 13:20:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830175
Page 178 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Jan-12-2021 13:20:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-12-2021 13:20:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-12-2021 13:20:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-12-2021 13:20:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
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 13:20:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830176
Page 179 of 195
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-13-2021 13:49:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/5/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-13-2021 13:49:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830177
Page 180 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-03-2021 14:11:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/28/2021Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830178
Page 181 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-03-2021 14:11:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-03-2021 14:11:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-03-2021 14:11:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/28/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-03-2021 14:11:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-03-2021 14:11:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-03-2021 14:11:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830179
Page 182 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
6.a Sponsor ID:
Date Location User Value Reason
Feb-03-2021 14:11:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-03-2021 14:11:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Feb-03-2021 14:11:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830180
Page 183 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-03-2021 14:12:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021 14:12:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-03-2021 14:12:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-03-2021 14:12:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-03-2021 14:12:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
Feb-03-2021 14:12:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFYRJInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-03-2021 14:12:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BRFYRJInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830181
Page 184 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-03-2021 14:12:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-03-2021 14:12:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-03-2021 14:12:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-03-2021 14:12:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/28/2021 12:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-03-2021 14:12:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-03-2021 14:12:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830182
Page 185 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-03-2021 14:12:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-03-2021 14:12:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-03-2021 14:12:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-03-2021 14:12:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Feb-03-2021 14:12:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830183
Page 186 of 195
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Visit
Date Location User ValueReason
Mar-10-2021
23:04:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
4: Clo
sedAuto closed by Validation Check:
VC_SV001_11
Mar-10-2021
17:56:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Ans
weredThis has been completed
Mar-08-2021
05:49:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies query
Mar-08-2021
01:42:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
4: Op
enedDMW7624633;V103 Visit Date is
entered, but Disposition -
Treatment form at
FURTHER_VACCINATION_EOT
visit is not completed. Please
review and update as appropriate.
Mar-05-2021
08:30:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Feb/2
6/202
1New Information
Mar-05-2021
08:30:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
3: Del
etedClose Auto Query
Mar-05-2021
08:30:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
3: Can
didateErroneous Visit is marked, but date
of visit is entered. Please either
untick the erroneous visit button if
visit occurred, or mark any forms
containing data within this visit as
Not Done/Not Applicable at the
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830184
Page 187 of 195
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
form level.
Mar-05-2021
08:30:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Ans
weredTranscription Error
Mar-05-2021
08:30:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Feb/2
8/202
1Transcription Error
Mar-05-2021
02:59:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Op
enedDM: Erroneous visit is marked.
However, data is present on
CONTACT SV form. Please
confirm if this visit occurred. If
yes, kindly untick the Erroneous
visit button as appropriate or else
clarify.
Feb-23-2021
02:35:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Del
etedRest of form not initiated.
Feb-22-2021
09:50:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Can
didateErroneous Visit is marked, but date
of visit is entered. Please either
untick the erroneous visit button if
visit occurred, or mark any forms
containing data within this visit as
Not Done/Not Applicable at the
form level.
Feb-22-2021
09:49:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Jan/28
/2021Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-05-2021 08:30:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830185
Page 188 of 195
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Feb-22-2021 09:50:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830186
Page 189 of 195
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-04-2021 14:52:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-05-2021 08:30:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-05-2021 08:30:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of Contact
26/Feb/2021 is not
equal to the Date of
Visit 28/Feb/2021
within same visit.
Please review and
update as appropriate.
Mar-04-2021 14:52:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of Contact
26/Feb/2021 is not
equal to the Date of
Visit 28/Jan/2021
within same visit.
Please review and
update as appropriate.
Mar-04-2021 14:52:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Feb/26/2021Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0830187
Page 190 of 195
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-10-2021 16:48:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/26/2021Initial Entry
Mar-10-2021 16:48:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-24-2021 13:54:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-10-2021 16:48:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
Mar-10-2021 16:48:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-24-2021 13:54:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Status:
Date Location User Value Reason
Mar-11-2021
23:45:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Close
dResponse satisfies
query
Mar-11-2021
13:55:48
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ans
weredVisit 3 not done.
Participant missed
appointment. Visit
103 has been
completed.
Mar-11-2021
00:00:37
(UTC-05:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2: Open
edDMW7668970;Status
on the Disposition -
Treatment form is
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0830188
Page 191 of 195
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Eastern Time
(US & Canada)COMPLETED, but
Visit 3 Date is
missing. Please
review and update as
appropriate.
Mar-10-2021
16:50:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Close
dClose Auto Query
Mar-10-2021
16:50:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETED"received non-study
COVID-19 vaccine"
Mar-10-2021
16:49:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Open
edResponse to "Status"
is OTHER but
"Specify Status" is
missing.
Mar-10-2021
16:49:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERNew Information
Mar-10-2021
16:48:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
Mar-10-2021
16:48:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Feb-24-2021
13:54:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-10-2021 16:48:16
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830189
Page 192 of 195
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(US & Canada)
Feb-24-2021 13:54:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830190
Page 193 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-11-2021 13:53:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Mar-10-2021 16:47:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COMPLETEDInitial Entry
Mar-08-2021 15:11:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDparticipant missed visit
3
Mar-01-2021 14:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Sep-15-2020 14:00:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-15-2020 13:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-11-2021 13:53:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Jan/5/2021Transcription Error
Mar-11-2021 13:52:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Jan/5/2021Transcription Error
Mar-10-2021 16:47:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Feb/26/2021Initial Entry
Mar-08-2021 15:11:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Jan/5/2021participant missed visit
3
Mar-01-2021 14:10:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Jan/5/2021Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830191
Page 194 of 195
***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: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-15-2020 14:00:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/14/2020Initial Entry
Sep-15-2020 13:58:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/14/2020Initial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4)
FDA-CBER-2021-5683-0830192
Page 195 of 195
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1248 Site Name: (1248) SNBL Clinical Pharmacology Center
Subject No: 12481163 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-17-2020 14:14:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f29\Final\Final On: 01-Apr-2021 03:36 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0830193