125742 S1 M5 CRF c4591001 1152 11521497

Document text

Page 1 of 150
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 version08 SEP 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943175
Page 2 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/7/2020
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943176
Page 3 of 150
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Demography
1.Subject ID [11521497]
2.Birth Date: /1948
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943177
Page 4 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943178
Page 5 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943179
Page 6 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943180
Page 7 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[nephrolithiasis]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type II diabetes]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943181
Page 8 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[prostatism]
Start Date: UNK/UNK/2019
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to celery]
Start Date: UNK/UNK/2000
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[allergy to mango]
Start Date: UNK/UNK/2000
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lithotripsy]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hearing loss]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943182
Page 9 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943183
Page 10 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Vital Signs
1.Date: Oct/7/2020
2.Weight: [172.2]
3.Unit: LB
4.Height: [69.5]
5.Unit: in
6.Body Mass Index: [25.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943184
Page 11 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/7/2020
2.Randomization Number: [267518]
3.Randomization Group: [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943185
Page 12 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
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 [BP0SVN]
5.bSample ID [BP0SVP]
5.cSample ID [BNT3DN]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943186
Page 13 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
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 [BP0SLR]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943187
Page 14 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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/7/2020 12:52
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
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943188
Page 15 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943189
Page 16 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943190
Page 17 of 150
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943191
Page 18 of 150
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943192
Page 19 of 150
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943193
Page 20 of 150
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943194
Page 21 of 150
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943195
Page 22 of 150
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943196
Page 23 of 150
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943197
Page 24 of 150
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943198
Page 25 of 150
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943199
Page 26 of 150
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943200
Page 27 of 150
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943201
Page 28 of 150
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943202
Page 29 of 150
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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: [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943203
Page 30 of 150
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943204
Page 31 of 150
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943205
Page 32 of 150
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943206
Page 33 of 150
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943207
Page 34 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943208
Page 35 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943209
Page 36 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943210
Page 37 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943211
Page 38 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943212
Page 39 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Unplanned Assessments
1.Assessments
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943213
Page 40 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  vasovagal syncope  Oct/26/2020 U
NK:UNK NO
End Date Time:
Oct/26/2020 UNK:
UNK
 Repeating
Pages
 2. DELETED ADVERSE
EVENT 2  Shigellosis  Oct/26/2020 U
NK:UNK NO
End Date Time:
Nov/11/2020 UNK:
UNK
 Repeating
Pages
 3. ADVERSE
EVENT 3  sepsis related to Shig
ella infection Oct/26/2020 U
NK:UNK NO
End Date Time:
Nov/11/2020 UNK:
UNK
 Repeating
Pages
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943214
Page 41 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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)[vasovagal syncope]
4.Start Date Time: Oct/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/26/2020 UNK:UNKComments
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:
[sepsis related to shigella infection]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943215
Page 42 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943216
Page 43 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[Shigellosis ]
4.Start Date Time: Oct/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/11/2020 UNK:UNK
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?
YES
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
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
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943217
Page 44 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
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:
[Shigella infection ]
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?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020437859 ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943218
Page 45 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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)[sepsis related to Shigella infection]
4.Start Date Time: Oct/26/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/11/2020 UNK:UNK
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?
YES
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
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
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943219
Page 46 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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:
[Shigella infection]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2020437859]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943220
Page 47 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943221
Page 48 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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[ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943222
Page 49 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943223
Page 50 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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: //
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943224
Page 51 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943225
Page 52 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943226
Page 53 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943227
Page 54 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943228
Page 55 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943229
Page 56 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943230
Page 57 of 150
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Queries, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/6/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943231
Page 58 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943232
Page 59 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943233
Page 60 of 150
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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?
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943234
Page 61 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943235
Page 62 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943236
Page 63 of 150
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943237
Page 64 of 150
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943238
Page 65 of 150
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943239
Page 66 of 150
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943240
Page 67 of 150
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
:Nov/11/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943241
Page 68 of 150
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943242
Page 69 of 150
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943243
Page 70 of 150
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943244
Page 71 of 150
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943245
Page 72 of 150
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Nov/11/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [SEPSIS RELATED TO SHIGELLA INFECTION]
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943246
Page 73 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/11/2020
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943247
Page 74 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943248
Page 75 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943249
Page 76 of 150
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormOct-07-2020 16:41:31 (UTC-08:00) Pacific
Time (US & Canada)Not Applicable
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943250
Page 77 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
FormMar-04-2021 07:51:24 (UTC-08:00) Pacific
Time (US & Canada)SUBJECT EXPIRED.
Not Done
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943251
Page 78 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
1Mar-04-2021 07:51:24 (UTC-08:00) Pacific
Time (US & Canada)SUBJECT EXPIRED.
Not Done
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943252
Page 79 of 150
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
2Mar-04-2021 07:51:24 (UTC-08:00) Pacific
Time (US & Canada)SUBJECT EXPIRED.
Not Done
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943253
Page 80 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
ItemDate User Comment
5Nov-18-2020 11:24:09 (UTC-08:00) Pacific
Time (US & Canada)
5Nov-16-2020 08:50:11 (UTC-08:00) Pacific
Time (US & Canada)Unknown
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943254
Page 81 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
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 Feb-15-2021 09:11:43 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald
Brandon Approved Jan-21-2021 11:31:21 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldBrandon, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-07-2020 07:20:04 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald
Brandon Approved Nov-24-2020 20:19:46 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldBrandon, 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.
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943255
Page 82 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
 N/A Nov-18-2020 11:24:09 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald
Brandon Approved Nov-16-2020 12:29:18 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldBrandon, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-16-2020 05:48:23 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald
Brandon Approved Nov-13-2020 10:00:44 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldBrandon, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-12-2020 13:48:15 (UTC-08:00) Pacific
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943256
Page 83 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Donald
Brandon Approved Nov-10-2020 18:10:28 (UTC-08:00) Pacific
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldBrandon, 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.
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943257
Page 84 of 150
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-07-2020 16:40:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-07-2020 16:40:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943258
Page 85 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-07-2020 16:40:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/7/2020Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943259
Page 86 of 150
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-13-2020 03:21:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-12-2020 14:32:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered AE had been entered
Nov-09-2020 03:35:34
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020437859
faint(onset
date:26Oct2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-07-2020 16:40:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11521497Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-07-2020 16:39:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1948Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-07-2020 16:40:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943260
Page 87 of 150
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Oct-07-2020 16:40:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-07-2020 16:40:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943261
Page 88 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 16:41:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943262
Page 89 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-07-2020 16:41:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020 16:41:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-07-2020 16:41:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943263
Page 90 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1.a
Date Location User Value Reason
Oct-07-2020 16:42:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:osteoarthritis
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-07-2020 16:42:14
(UTC-08:00) Pacific
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
Oct-07-2020 16:42:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
osteoarthritisInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-07-2020 16:42:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-07-2020 16:42:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943264
Page 91 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b
Date Location User Value Reason
Oct-07-2020 16:42:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:nephrolithiasis
Start Date: UNK/UNK/199
9
Ongoing: NO
End Date:
UNK/UNK/
1999Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943265
Page 92 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.b Line/MH Number:
Date Location User Value Reason
Oct-07-2020 16:42:45
(UTC-08:00) Pacific
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
Oct-07-2020 16:42:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
nephrolithiasisInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-07-2020 16:42:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1999Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-07-2020 16:42:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1999Initial Entry
1.c
Date Location User Value Reason
Oct-07-2020 16:43:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:hypertension
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943266
Page 93 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.c Line/MH Number:
Date Location User Value Reason
Oct-07-2020 16:43:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 16:43:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-07-2020 16:43:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-07-2020 16:43:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-07-2020 16:43:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Type II diabet
es
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943267
Page 94 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.d Line/MH Number:
Date Location User Value Reason
Oct-07-2020 16:43:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 16:43:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type II diabetesInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-07-2020 16:43:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-07-2020 16:43:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-07-2020 16:44:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:prostatism
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943268
Page 95 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.e Line/MH Number:
Date Location User Value Reason
Oct-07-2020 16:44:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 16:44:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
prostatismInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-07-2020 16:44:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-07-2020 16:44:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-07-2020 16:44:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:allergy to cel
ery
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943269
Page 96 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.f Line/MH Number:
Date Location User Value Reason
Oct-07-2020 16:44:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 16:44:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
allergy to celeryInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-07-2020 16:44:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-07-2020 16:44:53
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-07-2020 16:45:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:allergy to ma
ngo
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943270
Page 97 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
1.g Line/MH Number:
Date Location User Value Reason
Oct-07-2020 16:45:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 16:45:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
allergy to mangoInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-07-2020 16:45:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-07-2020 16:45:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-07-2020 16:45:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:lithotripsy
Start Date: UNK/UNK/199
9Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943271
Page 98 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Ongoing: NO
End Date:
UNK/UNK/
1999
1.h Line/MH Number:
Date Location User Value Reason
Oct-07-2020 16:45:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 16:45:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
lithotripsyInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-07-2020 16:45:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1999Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-07-2020 16:45:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1999Initial Entry
1.i
Date Location User Value Reason
Oct-08-2020 07:45:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:9Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943272
Page 99 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Medical History T
erm:hearing loss
Start Date: UNK/UNK/2
010
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Oct-08-2020 07:45:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-08-2020 07:45:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
hearing lossInitial Entry
1.i Start Date:
Date Location User Value Reason
Oct-08-2020 07:45:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-08-2020 07:45:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943273
Page 100 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-07-2020 16:46:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943274
Page 101 of 150
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date:
Date Location User Value Reason
Oct-07-2020 17:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-07-2020 17:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
172.2Initial Entry
3. Unit:
Date Location User Value Reason
Oct-07-2020 17:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-07-2020 17:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
69.5Initial Entry
5. Unit:
Date Location User Value Reason
Oct-07-2020 17:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-07-2020 17:27:47
(UTC-08:00) PacificACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.1Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943275
Page 102 of 150
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
7.a
Date Location User Value Reason
Oct-07-2020 17:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 98.3
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-07-2020 17:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-07-2020 17:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-07-2020 17:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-07-2020 17:27:47
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943276
Page 103 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-07-2020 17:28:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-07-2020 17:28:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
267518Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943277
Page 104 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 17:28:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 17:28:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020 21:28:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 17:28:16
(UTC-08:00) Pacific
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-07-2020 17:28:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020 21:28:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP0SVNInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943278
Page 105 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Oct-07-2020 21:28:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP0SVNInitial Entry
5.b
Date Location User Value Reason
Oct-07-2020 21:28:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP0SVPInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-07-2020 21:28:31
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP0SVPInitial Entry
5.c
Date Location User Value Reason
Oct-07-2020 21:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNT3DNInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-07-2020 21:28:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNT3DNInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943279
Page 106 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 17:28:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 17:28:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020 21:28:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 17:28:27
(UTC-08:00) Pacific
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-07-2020 17:28:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020 21:28:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP0SLRInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943280
Page 107 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5.a Sample ID
Date Location User Value Reason
Oct-07-2020 21:28:57
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP0SLRInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943281
Page 108 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-07-2020 17:28:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-07-2020 17:28:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-07-2020 17:28:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-07-2020 17:28:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020 12:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-07-2020 17:28:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-07-2020 17:28:52
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0943282
Page 109 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-07-2020 17:28:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-07-2020 17:28:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-07-2020 17:28:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943283
Page 110 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-07-2020 17:29:02
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943284
Page 111 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 07:51:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-04-2021 07:51:24
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943285
Page 112 of 150
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Nov-12-2020 13:48:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0943286
Page 113 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-08-2021 05:43:05
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Deleted Duplicate, per
query.
Dec-29-2020 11:36:45
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943287
Page 114 of 150
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
Date Location User Value Reason
Dec-29-2020 11:39:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943288
Page 115 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Nov-12-2020 13:48:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-12-2020 13:48:15
(UTC-08:00) Pacific
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
Jan-19-2021 05:19:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Jan-18-2021 15:17:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Answer remains the
same. Records do
not indicate a
specific reason for
the vasovagal
syncope.
Jan-15-2021 05:17:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened clinical: query was
to confirm dx was
vasovagal syncope
rather than a
hypotensive event
due to sepsis.
Thanks
Jan-15-2021 04:42:13
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Correct as far as we
can tell. Not sure
why this is queried.
Jan-13-2021 07:22:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened clinical: pls confirm
AE term is correct
since causality is
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943289
Page 116 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
listed as sepsis.
Thanks
Nov-16-2020 08:48:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
vasovagal syncopeChanged
Information
Nov-14-2020 12:54:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Appreciate the
prompt response.
Thank you.
Nov-13-2020 16:06:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered No other
information is
available at this
time. We will
continue to
diligently attempt to
get more
information and
provide it to you as
we get it.
Nov-13-2020 11:14:56
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Per case narrative,
the subject was in
the intensive care
unit (ICU).
However, cause of
hospitalization was
unknown. Please
provide, with a FU
report, final
diagnosis and
discharge summary
if available. Thank
you
Nov-12-2020 13:48:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FaintingInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-12-2020 13:48:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020 UNK:UNKInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b)(4),(b)
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943290
Page 117 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-18-2020 11:24:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/26/2020 UNK:UNKInitial Entry
Nov-18-2020 11:24:09
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Nov-16-2020 08:50:11
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
Nov-16-2020 08:49:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Changed
Information
Nov-12-2020 13:48:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-11-2021 17:08:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Jan-11-2021 15:23:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-11-2021 15:23:39
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Transcription Error
Jan-11-2021 06:15:17
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify the grade. If
G4 life-threatening,
it met SAE criteria
and SAE for this
term should be
reported. If not
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (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) (4)
(b) (4)
FDA-CBER-2021-5683-0943291
Page 118 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
considered a SAE, a
lower grade, e.g.,
G3, should be
assigned.
Nov-18-2020 11:24:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Changed
Information
Nov-12-2020 13:48:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial 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
Jan-10-2021 23:28:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Deleted Close Auto Query
Jan-10-2021 23:00:41
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies query
Jan-08-2021 05:45:16
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Jan-08-2021 05:44:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Candidate For AE vasovagal syncope:
Response to "Is the adverse
event serious?" is 'No' but
"Serious Adverse Event
Number" is present.
Jan-08-2021 05:44:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened For AE vasovagal syncope:
Response to "Is the adverse
event serious?" is "No" but
"What was the outcome of
this adverse event?" is
'Fatal'.
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943292
Page 119 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-08-2021 05:44:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered This was a symptom of the
actual SAE, per PI.
Jan-08-2021 05:44:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOThis was a symptom of the
actual SAE, per PI.
Jan-08-2021 03:46:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened SAE RECON: Form is not
frozen. please updated
accordingly
Jan-05-2021 13:42:51
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered PI says this was due to the
shigellosis and thus not an
SAE in itself. Please
unfreeze this line and I will
make the change. Thank
you.
Jan-05-2021 05:27:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened SAE RECON 1: Please
submit a follow up AEM
form to clarify with Pfizer
Safety that VASOVAGAL
SYNCOPE is still a valid
SAE.
Jan-04-2021 07:51:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered This was the reason the
subject was hospitalized.
Doesn't that make it an
SAE?
Jan-04-2021 02:42:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened SAE RECON:
AER#2020437859,vasovagal
syncope event is no longer
listed in Safety database but
recorded as serious in AE
CRF.Please confirm event
seriousness.If event is not
serious, please downgrade in
AE CRF.
Nov-18-2020
11:25:34 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
NONew Information
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (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)
FDA-CBER-2021-5683-0943293
Page 120 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Did this serious event res
ult in death?
YES
Did this serious event re
quire or prolong hospital
ization?
YES
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
YES
Other medically importa
nt serious event
NO
Nov-13-2020
03:22:58 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020
13:49:00 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-12-2020
13:49:00 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
NONew Information
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0943294
Page 121 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Did this serious event res
ult in death?
NO
Did this serious event re
quire or prolong hospital
ization?
YES
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
YES
Other medically importa
nt serious event
NO
Nov-12-2020
13:48:15 (UTC-08:00)
Pacific 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.
Nov-12-2020
13:48:15 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Fainting: Response
to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Nov-12-2020
13:48:15 (UTC-08:00)
Pacific Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0943295
Page 122 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
NO
Did this serious event res
ult in death?
NO
Did this serious event re
quire or prolong hospital
ization?
YES
Is this serious event life t
hreatening?
YES
Other medically importa
nt 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.
Date Location User Value Reason
Nov-12-2020 13:48:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-11-2021 17:08:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Jan-11-2021 15:26:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Jan-11-2021 15:26:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:Changed
Information
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)
(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943296
Page 123 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
OTHER
If Other, specify:
sepsis related to shigella i
nfection
Jan-11-2021 06:18:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify if this was
related to the SAE
of Sepsis, e.g., a
symptom of it. If
yes, please make the
corresponding
change.
Nov-12-2020 13:48:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
UnknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-09-2020 02:28:50
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)
(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943297
Page 124 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-07-2020
07:20:04
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Subject expired, so second
vaccination is Not Applicable.
Dec-07-2020
07:20:04
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLESubject expired, so second
vaccination is Not Applicable.
Dec-07-2020
02:50:43
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 1: Reissued:Op
enedform is unfrozen. if correct action
taken is not applicable. please
update accordingly.
Dec-04-2020
06:31:00
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered I am unable to change this to
match the safety database because
this page is frozen.
Dec-04-2020
04:29:37
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020437859,action
taken was updated to DRUG
WITHDRAWN in AE CRF while
NOT APPLICABLE in Safety
database.Please confirm correct
action taken. If safety update is
required, please submit a follow
up form
Nov-16-2020
09:04:04
(UTC-08:00) Pacific
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
DRUG WITHDRAW
NSubject will receive no more
study vaccine.
Nov-12-2020
13:48:15
(UTC-08:00) PacificACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943298
Page 125 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Time (US &
Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-11-2021 17:08:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Jan-11-2021 15:27:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Jan-11-2021 15:27:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOChanged
Information
Jan-11-2021 06:21:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify what
medication was
given for this AE?
Nov-12-2020 13:48:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-11-2021 17:09:10
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Jan-11-2021 15:27:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Jan-11-2021 15:27:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOChanged
Information
Jan-11-2021 06:19:28
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify what
non-drug treatment
was given for this
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943299
Page 126 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
AE.
Nov-12-2020 13:48:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-08-2021
05:45:16
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDChanged Information
Nov-24-2020
06:41:05
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 6: Closed Thank you.
Nov-23-2020
07:22:18
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 6: Answered We have already submitted all the
information we have. We do not
have access to records. We do not
know reason for ICU admission, or
even if ICU admission actually
occurred. The subject died in the
hospital.
Nov-20-2020
14:59:10
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 6: Reissued:
OpenedKindly provide information on
hospital course, including work-up,
imaging, and treatment received in a
FU report. Please clarify reason for
ICU admission and if the subject
died during hospitalization. Thank
you
Nov-19-2020
15:08:09
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 6: Answered We don't have those either. We will
submit the information when are
able to obtain it. It will likely be at
least 8 weeks.
Nov-19-2020
15:00:54
(UTC-08:00)
Pacific Time (USACV0PFEINFP6000  Giselle
CastilloQuery 6: Opened Death event has been recorded on
CRF. However, we do not have the
cause of death or a death certificate.
Kindly submit a FU report with this
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (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)
FDA-CBER-2021-5683-0943300
Page 127 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
& Canada) information. Thank you.
Nov-18-2020
11:26:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Closed Close Auto Query
Nov-18-2020
11:25:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Opened Response to "What was the outcome
of this adverse event?" is 'Fatal' but
Date of Collection / Notification of
Death on the Death Details form is
not completed. Please review and
update as appropriate.
Nov-18-2020
11:25:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Nov-18-2020
11:25:59
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FATALNew Information
Nov-18-2020
11:24:38
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened For AE vasovagal syncope:
Response to "What was the outcome
of this adverse event?" is 'Unknown'
but End Date/Time is provided or "Is
the adverse event still ongoing?" is
marked "Yes".
Nov-16-2020
12:33:25
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Nov-16-2020
08:49:58
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Nov-16-2020
08:48:00ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened For AE vasovagal syncope:
Response to "What was the outcome
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943301
Page 128 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)of this adverse event?" is 'Unknown'
but End Date/Time is provided or "Is
the adverse event still ongoing?" is
marked "Yes".
Nov-16-2020
06:00:11
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-16-2020
05:51:12
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered Well, the answer certainly cannot be
"No", so it HAS to be "Yes".
Unknown is not a choice in that
field.
Nov-16-2020
05:48:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE Fainting: Response to "What
was the outcome of this adverse
event?" is 'Unknown' but End
Date/Time is provided or "Is the
adverse event still ongoing?" is
marked "Yes".
Nov-16-2020
05:48:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed Information
Nov-16-2020
05:48:23
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNKNOWNChanged Information
Nov-14-2020
05:52:13
(UTC-08:00)
Pacific Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020437859,outcome
was reported as UNKNOWN to
Safety DB however, recorded as
NOT RECOVERED/NOT
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Nov-12-2020
13:48:15ACV0PFEINFP6000  Data Entry:
NOT RECOVEREInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943302
Page 129 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00)
Pacific Time (US
& Canada)D/NOT RESOLVE
D
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-02-2020 04:38:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Deleted hold - review cause
of death and AE
entries
Dec-02-2020 04:29:42
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Candidate CLINQUERY: Field
indicates the fatal
event of vasovagal
syncope 26Oct20
was not the cause of
study end. However,
FUP tab indicates
death as reason for
end of study, dated
11Nov20. Please
review if this field
should be updated to
match FUP; clarify
dates
Nov-12-2020 13:48:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-10-2021 23:28:37
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry: downgraded to non
serious
Nov-13-2020 03:22:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020437859Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943303
Page 130 of 150
***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, Deleted
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
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
Jan-10-2021 23:04:26
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed event inactivated in Inform
Jan-08-2021 05:42:25
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered OK.
Jan-08-2021 01:12:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020437859,
Shigellosis was recorded as
a separate event. Please
confirm if this is a singular
event of shigella sepsis and
AE#2 is duplicate of
adverse event 3.
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ShigellosisInitial Entry
4. Start Date Time:
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943304
Page 131 of 150
***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, Deleted
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/11/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
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
Jan-04-2021 00:58:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Jan-02-2021 03:09:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:Shigellosis(Onset
date:26Oct2020) is not
reported to Safety
database but marked
serious on AE CRF.
Confirm seriousness and
report to Pfizer
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943305
Page 132 of 150
***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, Deleted
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
immediately. If this event
is not serious, downgrade
the event on AE CRF
Jan-02-2021 03:08:03
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be addressed
internally
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Shigellosis:
Response to "Is the
adverse event serious?" is
'Yes' but "Serious Adverse
Event Number" is blank.
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resul
t in death?
YES
Did this serious event requ
ire or prolong hospitalizati
on?
YES
Did this serious event resul
t in persistent or significan
t disability/incapacity?
NO
Is this serious event life thr
eatening?
YES
Other medically important
serious eventInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943306
Page 133 of 150
***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, Deleted
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
Shigella infectionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943307
Page 134 of 150
***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, Deleted
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
*** THIS REPEATING FORM HAS BEEN DELETED ***
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATALInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-29-2020 11:44:00
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOI know this will be
queried, even
though this IS a
reason the subject
discontinued from
the study . . .
Dec-29-2020 11:36:45
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-04-2021 00:58:12
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020437859Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943308
Page 135 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Category:
Date Location User Value Reason
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
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
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
sepsis related to Shigella infectio
nInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-16-2021 15:11:06
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-15-2021 09:11:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered OK
Feb-15-2021 09:11:43 ACV0PFEINFP6000  Data Entry: OK
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0943309
Page 136 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(UTC-08:00) Pacific
Time (US & Canada)NO
End Date Time:
Nov/11/2020 UNK:UNK
Feb-15-2021 01:33:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
please clarify if the
stop date for sepsis
related to Shigella
infection should be
reported as
11Nov2020 for
consistency with the
date of death.
Feb-12-2021 13:28:54
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate CLINQUERY:
please clarify if the
stop date for sepsis
related to Shigella
infection should be
reported as
11Nov2020 for
consistency with the
date of death.
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/10/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-29-2020 11:39:33
(UTC-08:00) Pacific
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
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943310
Page 137 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-04-2021 01:06:46
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed event entered in
SDB
Jan-02-2021 03:11:52
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE RECON:sepsis
related to Shigella
infection(Onset
date:26Oct2020) 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,
downgrade the event
on AE CRF
Jan-02-2021 03:10:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed internally
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE sepsis
related to Shigella
infection: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
YES
Did this serious event require
or prolong hospitalization?Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943311
Page 138 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threat
ening?
YES
Other medically important seri
ous event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatmen
t(s), this event is due to:
OTHER
If Other, specify:
Shigella infectionInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943312
Page 139 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Mar-08-2021 12:27:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed AE entry confirmed
correct by site; EOT
change to be
reviewed
Mar-08-2021 08:57:27
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered I WOULD
CHANGE THAT
DATE, BUT THE
PAGE IS FROZEN
AND LOCKED.
Feb-25-2021 02:32:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY: EOT
page reports
treatment was
discontinued on
06Nov20 prior to
death on 11Nov20.
Please review if this
data is correct. If so,
please then review
in connection with
the AE, and review
if drug was
withdrawn as
reported
Feb-23-2021 04:10:22
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Candidate CLINQUERY: EOT
page reports
treatment was
discontinued on
06Nov20 prior to
death on 11Nov20.
Please review if this
data is correct. If so,
please then review
in connection with
the AE, and review
if drug was
withdrawn as
reported
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943313
Page 140 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATALInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-29-2020 22:04:30
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-29-2020 11:42:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered OK. They both did .
. .
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened More than 1 AE for
this patient has
"Did the adverse
event cause the
subject to be
discontinued from
the study?" marked
as 'Yes'.
Dec-29-2020 11:39:15
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943314
Page 141 of 150
***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, Frozen
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Jan-04-2021 01:02:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020437859Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943315
Page 142 of 150
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Queries, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-11-2021 05:02:14
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY: Per
query response on
AE data, request
was made to
unfreeze EOT page
for update. Please
review as needed
Nov-16-2020 09:05:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/6/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-16-2020 09:05:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User ValueReason
Nov-16-2020
18:11:14
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse satisfies
query
Nov-16-2020
16:32:05
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dNot so. Please
review.
Nov-16-2020
12:24:50
(UTC-08:00)
Pacific TimeACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5388814;Status
is reported as
Adverse Event, but
there is no Adverse
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943316
Page 143 of 150
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Queries, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US &
Canada)Event with 'Latest
Action Taken with
Study Treatment'
reported as DRUG
WITHDRAWN.
Please review and
update as
appropriate.
Nov-16-2020
09:05:04
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
ADV
ERSE
EVE
NTInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943317
Page 144 of 150
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-18-2020 11:26:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-18-2020 11:26:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-18-2020 11:26:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-18-2020 11:26:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Response to 'Status'
is 'Death' on
Disposition- Folow
up, but 'Death' CRF
is not yet initiated.
Please review and
update as
appropriate.
Nov-18-2020 11:26:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DEATHInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943318
Page 145 of 150
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Nov-18-2020 11:26:58
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/11/2020Initial Entry
2.a
Date Location User Value Reason
Feb-15-2021 09:12:55
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cause of
Death Sta
tus:PRIMARY CAUSE
OF DEATH
Cause of
Death:SEPSIS RELATED
TO SHIGELLA INF
ECTIONYES, THANK
YOU.
Nov-18-2020 16:03:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cause of De
ath Status:PRIMARY CAU
SE OF DEATH
Cause of De
ath:Unknown diagno
sis.Changed
Information
Nov-18-2020 11:27:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cause of De
ath Status:PRIMARY CAU
SE OF DEATH
Cause of De
ath:Unknown at this t
ime.Initial Entry
2.a Cause of Death Status:
Date Location User Value Reason
Feb-23-2021 08:38:35
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Feb-23-2021 02:56:49
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject died while
in ICU
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (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-2021-5683-0943319
Page 146 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Feb-22-2021 15:03:38
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Medical Monitor_
Pls advice if the
subject was
discharged from
hospital prior death
or died while in
ICU? Thanks
Nov-18-2020 11:27:20
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CAUSE OF DEATHInitial Entry
2.a Cause of Death:
Date Location User Value Reason
Feb-16-2021
15:09:18
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Clo
sedResponse satisfies
query
Feb-15-2021
09:12:55
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Ans
weredYES, THANK
YOU.
Feb-15-2021
09:12:55
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SEPSIS REL
ATED TO S
HIGELLA I
NFECTIONYES, THANK
YOU.
Feb-12-2021
13:34:48
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ope
nedCLINQUERY:
please clarify if
the cause of death
should be updated
to sepsis related
to Shigella
infection to align
with the AE
reported as fatal.
Nov-18-2020
18:38:19
(UTC-08:00)
Pacific TimeACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Clo
sedDiscrepancy has
been closed.
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943320
Page 147 of 150
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
(US & Canada)
Nov-18-2020
16:03:43
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredChanged
Information
Nov-18-2020
16:03:43
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Unknown dia
gnosis.Changed
Information
Nov-18-2020
14:41:04
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Ope
nedClarify
UNKNOWN AT
THIS TIME. as
follow...Term
appears
incomplete. Are
you reporting
UNKNOWN
DIAGNOSIS?
UNKNOWN
DIAGNOSTIC
PROCEDURE?
UNKNOWN
THERAPEUTIC
PROCEDURE?
Please edit and
clarify further.
Thank you.
Nov-18-2020
11:27:20
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Unknown at t
his time.Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943321
Page 148 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-04-2021 13:04:43
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Rivkah Rosen Query 1: Closed Response satisfies
query
Mar-04-2021 07:52:05
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered OK. AS YOU CAN
TELL, SUBJECT
IS DECEASED.
Mar-02-2021 02:47:23
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Visit 2 is
overdue based on
expected visit
window. If visit 2
will never occur,
please mark Date of
Visit as ‘Not Done’
with form level
comment.
Nov-18-2020 11:26:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Nov-16-2020 09:05:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-07-2020 17:28:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-07-2020 16:41:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-18-2020 11:26:32
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/11/2020Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0943322
Page 149 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Nov-16-2020 09:05:04
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/6/2020Initial Entry
Oct-07-2020 17:28:07
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
Oct-07-2020 16:41:48
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b) (4)
FDA-CBER-2021-5683-0943323
Page 150 of 150
***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: 1152 Site Name: (1152) California Research Foundation
Subject No: 11521497 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:56
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-10-2020 13:18:59
(UTC-08:00) Pacific
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2fce\Final\Final On: 01-Apr-2021 03:52 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0943324