125742 S1 M5 CRF c4591001 1135 11351563

Document text

Page 1 of 169
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
version06 OCT 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939647
Page 2 of 169
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/27/2020
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939648
Page 3 of 169
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11351563]
2.Birth Date: /1992
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939649
Page 4 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939650
Page 5 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939651
Page 6 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathOct/27/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939652
Page 7 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[nearsighted]
Start Date: UNK/UNK/2002
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[hypothyroidism]
Start Date: UNK/UNK/2005
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[overweight]
Start Date: UNK/UNK/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[obese]
Start Date: UNK/UNK/2015
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[fibromyalgia]
Start Date: UNK/UNK/2017
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[gastric bypass]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939653
Page 8 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[depression]
Start Date: UNK/UNK/2013
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[gastric bypass surgery]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939654
Page 9 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939655
Page 10 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Oct/27/2020
2.Weight: [100.4]
3.Unit: kg
4.Height: [162.0]
5.Unit: cm
6.Body Mass Index: [38.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939656
Page 11 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/27/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939657
Page 12 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/27/2020
2.Randomization Number: [401109]
3.Randomization Group: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939658
Page 13 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BP93J1]
5.bSample ID [BMNXCB]
5.cSample ID [BMNXCD]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939659
Page 14 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BRFZB4]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939660
Page 15 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/27/2020 13:16
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939661
Page 16 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939662
Page 17 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/20/2020
2.Erroneous Visit
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939663
Page 18 of 169
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Nov/20/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939664
Page 19 of 169
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/20/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939665
Page 20 of 169
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/20/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRFZM9]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939666
Page 21 of 169
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: Nov/20/2020 10:43
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939667
Page 22 of 169
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939668
Page 23 of 169
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/16/2020
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 [BRCD4C]
5.bSample ID [BSJVGD]
5.cSample ID [BSJVGF]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939669
Page 24 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939670
Page 25 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939671
Page 26 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939672
Page 27 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939673
Page 28 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939674
Page 29 of 169
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939675
Page 30 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939676
Page 31 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939677
Page 32 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939678
Page 33 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939679
Page 34 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still Ong
oingForm Instance
 1.ADVERSE EVE
NT 1  acute pancreatit
is Nov/21/2020 UNK:U
NK NO
End Date Time:
Nov/24/2020 UNK:UNK
 Repeating
Pages
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939680
Page 35 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[acute pancreatitis]
4.Start Date Time: Nov/21/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/24/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[pending records]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939681
Page 36 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
11.Was a Concomitant Medication given? YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020498809]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939682
Page 37 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939683
Page 38 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939684
Page 39 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939685
Page 40 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: //
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939686
Page 41 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939687
Page 42 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939688
Page 43 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939689
Page 44 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939690
Page 45 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939691
Page 46 of 169
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939692
Page 47 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939693
Page 48 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939694
Page 49 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939695
Page 50 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939696
Page 51 of 169
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939697
Page 52 of 169
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939698
Page 53 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939699
Page 54 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939700
Page 55 of 169
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939701
Page 56 of 169
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent - Asymptomatic Surveillance
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/2/2021
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939702
Page 57 of 169
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/2/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9MGH]
5.bSample ID [BSG9RV]
5.cSample ID [BSG9RX]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939703
Page 58 of 169
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/2/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9MGT]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939704
Page 59 of 169
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/15/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/15/2021
2.Erroneous Visit
COVID-19 Surveillance Visit
3.COVID-19 Surveillance Visit: SSWAB_WEEK2
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939705
Page 60 of 169
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/15/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Feb/15/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [AA61650]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939706
Page 61 of 169
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Dec/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939707
Page 62 of 169
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939708
Page 63 of 169
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939709
Page 64 of 169
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939710
Page 65 of 169
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/16/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939711
Page 66 of 169
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939712
Page 67 of 169
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939713
Page 68 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939714
Page 69 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/17/2021
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939715
Page 70 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939716
Page 71 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Feb/17/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939717
Page 72 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/17/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939718
Page 73 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGVBK]
5.bSample ID [BSG9YT]
5.cSample ID [BSG9YV]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939719
Page 74 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/17/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRGVBL]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939720
Page 75 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/17/2021 11:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939721
Page 76 of 169
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939722
Page 77 of 169
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Mar/10/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939723
Page 78 of 169
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Mar/10/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR9MPM]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939724
Page 79 of 169
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Mar/10/2021 10:11
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939725
Page 80 of 169
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939726
Page 81 of 169
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939727
Page 82 of 169
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939728
Page 83 of 169
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939729
Page 84 of 169
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939730
Page 85 of 169
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939731
Page 86 of 169
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939732
Page 87 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/16/2020
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939733
Page 88 of 169
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Casebook Signature Form
1.Casebook Signature
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939734
Page 89 of 169
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939735
Page 90 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormOct-28-2020 10:12:46 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939736
Page 91 of 169
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION -
Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormFeb-17-2021 11:22:45 (UTC-08:00) Pacific Time
(US & Canada)Not Applicable
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939737
Page 92 of 169
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0939738
Page 93 of 169
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-28-2020 10:12:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-28-2020 10:12:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939739
Page 94 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-28-2020 10:12:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/27/2020Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939740
Page 95 of 169
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-28-2020 10:12:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11351563Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-28-2020 10:11:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1992Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-28-2020 10:12:30
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-28-2020 10:12:30
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-28-2020 10:12:30
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939741
Page 96 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-28-2020 10:12:39
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939742
Page 97 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-28-2020 10:13:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-28-2020 10:13:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-28-2020 10:13:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939743
Page 98 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Oct-28-2020 10:14:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:nearsighted
Start Date: UNK/UNK/20
02
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-28-2020 10:14:26
(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-28-2020 10:14:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
nearsightedInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-28-2020 10:14:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-28-2020 10:14:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-28-2020 10:15:18 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939744
Page 99 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-08:00) Pacific Time
(US & Canada)(autocalc) Line/MH Number: 2
Medical History Ter
m:hypothyroidism
Start Date: UNK/UNK/20
05
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Oct-28-2020 10:15:18
(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-28-2020 10:15:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
hypothyroidismInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-28-2020 10:15:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-28-2020 10:15:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-28-2020 10:15:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:overweight
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939745
Page 100 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.c Line/MH Number:
Date Location User Value Reason
Oct-28-2020 10:15:35
(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-28-2020 10:15:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
overweightInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-28-2020 10:15:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-28-2020 10:15:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Oct-28-2020 10:15:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Ter
m:obese
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939746
Page 101 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.d Line/MH Number:
Date Location User Value Reason
Oct-28-2020 10:15:48
(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-28-2020 10:15:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
obeseInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-28-2020 10:15:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-28-2020 10:15:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Oct-28-2020 10:16:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:fibromyalgia
Start Date: UNK/UNK/20
17
Ongoing: YESInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939747
Page 102 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e Line/MH Number:
Date Location User Value Reason
Oct-28-2020 10:16:16
(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-28-2020 10:16:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
fibromyalgiaInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-28-2020 10:16:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-28-2020 10:16:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-28-2020 10:18:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:gastric bypass
Start Date: UNK/UNK/20
16
Ongoing: YESInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939748
Page 103 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.f Line/MH Number:
Date Location User Value Reason
Oct-28-2020 10:18:33
(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-28-2020 10:18:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
gastric bypassInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-28-2020 10:18:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.f Ongoing:
Date Location User Value Reason
Oct-28-2020 10:18:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-28-2020 10:18:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:depression
Start Date: UNK/UNK/20
13
Ongoing: YESInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939749
Page 104 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.g Line/MH Number:
Date Location User Value Reason
Oct-28-2020 10:18:50
(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-28-2020 10:18:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
depressionInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-28-2020 10:18:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.g Ongoing:
Date Location User Value Reason
Oct-28-2020 10:18:50
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-28-2020 10:19:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:gastric bypass sur
gery
Start Date: UNK/UNK/2016
Ongoing: YESInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939750
Page 105 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.h Line/MH Number:
Date Location User Value Reason
Oct-28-2020 10:19:13
(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-28-2020 10:19:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
gastric bypass surgeryInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-28-2020 10:19:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-28-2020 10:19:13
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939751
Page 106 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-28-2020 10:19:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be HIV
POSITIVEInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939752
Page 107 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Oct-28-2020 10:19:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-28-2020 10:19:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
100.4Initial Entry
3. Unit:
Date Location User Value Reason
Oct-28-2020 10:19:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-28-2020 10:19:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
162.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-28-2020 10:19:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-28-2020 10:19:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
38.3Initial Entry
7.a
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0939753
Page 108 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Oct-28-2020 10:19:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 37.1
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-28-2020 10:19:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-28-2020 10:19:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
37.1Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-28-2020 10:19:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-28-2020 10:19:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0939754
Page 109 of 169
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-28-2020 10:20:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-28-2020 10:20:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-28-2020 10:20:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-28-2020 10:20:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-28-2020 10:20:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-28-2020 10:20:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939755
Page 110 of 169
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Oct-28-2020 10:20:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-28-2020 10:20:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-28-2020 10:20:01
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939756
Page 111 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-28-2020 10:20:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-28-2020 10:20:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
401109Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939757
Page 112 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 10:20:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 10:20:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-28-2020 10:23:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 10:20:24
(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-28-2020 10:20:24
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020 10:23:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP93J1Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 10:23:22
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
BP93J1Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939758
Page 113 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
5.b
Date Location User Value Reason
Oct-28-2020 10:23:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNXCBInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-28-2020 10:23:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BMNXCBInitial Entry
5.c
Date Location User Value Reason
Oct-28-2020 10:23:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNXCDInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-28-2020 10:23:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BMNXCDInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939759
Page 114 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-28-2020 10:20:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-28-2020 10:20:33
(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-28-2020 10:25:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 10:20:33
(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-28-2020 10:20:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-28-2020 10:25:03
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFZB4Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-28-2020 10:25:03
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
BRFZB4Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939760
Page 115 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0939761
Page 116 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-28-2020 10:22:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-28-2020 10:22:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-28-2020 10:22:37
(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-28-2020 10:22:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020 13:16Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-28-2020 10:22:37
(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-28-2020 10:22:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939762
Page 117 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Oct-28-2020 10:22:37
(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-28-2020 10:22:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-28-2020 10:22:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939763
Page 118 of 169
***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, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-28-2020 10:22:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUBJ
ECTInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939764
Page 119 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-23-2020
23:06:57
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Cl
osedClosed as per site
response, updated PD
tracker for clinical
review
Nov-23-2020
18:12:52
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: An
sweredsubject was out of
window by 1 day, PD
filed.
Nov-22-2020
22:54:26
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Op
enedPDQ: Date of visit at
V2_VAX2_L is out
of window for 1 days
from
V1_DAY1_VAX1_L
Dose Date. Please
verify and update.
Else, confirm in
query response
appropriately. 
Nov-20-2020
10:55:35
(UTC-08:00)
Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/202
0Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),(b)(6)
(b)(4),(b)(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0939765
Page 120 of 169
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Nov-20-2020 10:55:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
2.a
Date Location User Value Reason
Nov-20-2020 10:55:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.7
Temperature Unit: C
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-20-2020 10:55:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-20-2020 10:55:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-20-2020 10:55:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-20-2020 10:55:57
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939766
Page 121 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0939767
Page 122 of 169
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-20-2020 10:56:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-20-2020 10:56:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-20-2020 10:56:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-20-2020 10:56:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-20-2020 10:56:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-20-2020 10:56:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939768
Page 123 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Nov-20-2020 10:56:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-20-2020 10:56:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-20-2020 10:56:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939769
Page 124 of 169
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-20-2020 10:56:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-20-2020 10:56:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-20-2020 18:46:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-20-2020 10:56:19
(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.
Nov-20-2020 10:56:19
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/20/2020Initial Entry
5.a
Date Location User Value Reason
Nov-20-2020 18:46:21
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRFZM9Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-20-2020 18:46:21
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
BRFZM9Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939770
Page 125 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0939771
Page 126 of 169
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-20-2020 10:56:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-20-2020 10:56:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-20-2020 10:56:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-20-2020 10:56:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/20/2020 10:43Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-20-2020 10:56:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-20-2020 10:56:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939772
Page 127 of 169
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Nov-20-2020 10:56:51
(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
Nov-20-2020 10:56:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Nov-20-2020 10:56:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939773
Page 128 of 169
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User ValueReason
Dec-21-2020
01:33:49
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedClosed per SITE response,
added to PD tracker for
Clinical Review
Dec-18-2020
11:29:49
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredOriginal value is correct
Dec-18-2020
02:02:55
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 2 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. 
Dec-16-2020
16:17:39
(UTC-08:00)
Pacific Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Dec/1
6/202
0Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0939774
Page 129 of 169
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-16-2020 16:17:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-16-2020 16:17:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-16-2020 17:30:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-16-2020 16:17:47
(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.
Dec-16-2020 16:17:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/16/2020Initial Entry
5.a
Date Location User Value Reason
Dec-16-2020 17:30:35
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRCD4CInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-16-2020 17:30:35
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
BRCD4CInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939775
Page 130 of 169
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
5.b
Date Location User Value Reason
Dec-16-2020 17:30:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSJVGDInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-16-2020 17:30:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSJVGDInitial Entry
5.c
Date Location User Value Reason
Dec-16-2020 17:30:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSJVGFInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-16-2020 17:30:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSJVGFInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939776
Page 131 of 169
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Dec-17-2020 09:10:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939777
Page 132 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Dec-17-2020 09:10:22
(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-17-2020 09:10:22
(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
Mar-09-2021 06:37:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Closing query to FU at
a later date.
Mar-04-2021 03:44:42
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Could you pls provide
any updates?
Feb-25-2021 22:28:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered records received by
site, pending reivew
Feb-09-2021 12:13:30
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Thanks for confirming.
Please make every
effort possible to
obtain further
information and
respond to the query
once additional
information is
available.
Feb-01-2021 15:32:49
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered site pending medical
records
Dec-23-2020 12:46:48
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Clinical_ Per SAE
report, "Subject's test
results were elevated
which lead to
hospitalization". Kind
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0939778
Page 133 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
provide lab test
performed with results
and if test returned to
normal, the results in a
FU form. Thank you.
Dec-17-2020 09:10:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
acute pancreatitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-17-2020 09:10:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-17-2020 09:10:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/24/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-17-2020 09:10:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial 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
Dec-18-2020 04:14:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-17-2020 09:10:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE acute
pancreatitis: Response
to "Is the adverse
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939779
Page 134 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Dec-17-2020 09:10:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with
congenital anomaly or birth defect?
NO
Did this serious event result in deat
h?
NO
Did this serious event require or pro
long hospitalization?
YES
Did this serious event result in persi
stent or significant disability/incapa
city?
NO
Is this serious event life threatening
?
NO
Other medically important serious e
vent
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-17-2020 09:10:22
(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
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939780
Page 135 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Dec-17-2020 09:10:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s),
this event is due to:
OTHER
If Other, specify:
pending recordsInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-17-2020 09:10:22
(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-17-2020 09:10:22
(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-17-2020 09:10:22
(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-17-2020 09:10:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-17-2020 09:10:22
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0939781
Page 136 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Dec-18-2020 04:14:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020498809Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939782
Page 137 of 169
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-02-2021 17:15:31
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/2/2021Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939783
Page 138 of 169
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-02-2021 17:15:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/2/2021Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939784
Page 139 of 169
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-02-2021 17:15:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-02-2021 17:15:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-02-2021 21:16:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-02-2021 17:15:47
(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.
Feb-02-2021 17:15:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/2/2021Initial Entry
5.a
Date Location User Value Reason
Feb-02-2021 21:16:06
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR9MGHInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-02-2021 21:16:06
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
BR9MGHInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939785
Page 140 of 169
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
5.b
Date Location User Value Reason
Feb-02-2021 21:16:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSG9RVInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-02-2021 21:16:18
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSG9RVInitial Entry
5.c
Date Location User Value Reason
Feb-02-2021 21:16:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSG9RXInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-02-2021 21:16:28
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSG9RXInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939786
Page 141 of 169
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-02-2021 17:15:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-02-2021 17:15:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-02-2021 21:16:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-02-2021 17:15:54
(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.
Feb-02-2021 17:15:54
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/2/2021Initial Entry
5.a
Date Location User Value Reason
Feb-02-2021 21:16:40
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR9MGTInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-02-2021 21:16:40
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
BR9MGTInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939787
Page 142 of 169
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0939788
Page 143 of 169
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/15/2021Form: DATE OF VISIT - ASYMPTOMATIC SURVEILLANCE - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-15-2021 17:42:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/15/2021Initial Entry
3. COVID-19 Surveillance Visit:
Date Location User Value Reason
Feb-15-2021 17:42:11
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SSWAB_WEEK2Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939789
Page 144 of 169
***Confidential***
 
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/15/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-15-2021 17:42:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-15-2021 17:42:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-22-2021 20:07:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-17-2021 04:57:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-15-2021 17:42:20
(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.
Feb-15-2021 17:42:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/15/2021Initial Entry
5.a
Date Location User Value Reason
Feb-22-2021 20:07:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: AA61650Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939790
Page 145 of 169
***Confidential***
Header Text: c4591001
Visit: V202_SURVEIL_SWAB 1 - Unscheduled
Visit on Feb/15/2021Form: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB - eCRF Audit
Trail History
Form Version: 10-Oct-2020 15:57 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Feb-22-2021 20:07:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
AA61650Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939791
Page 146 of 169
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-16-2020 16:17:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-16-2020 16:17:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-16-2020 16:17:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939792
Page 147 of 169
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-17-2021 11:22:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/16/2021Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939793
Page 148 of 169
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-17-2021 11:22:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for Vacci
nation 3
Participant is:
eligible per local/national recommen
dations and confirmed to have recei
ved only placebo at Vaccination 1/2Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939794
Page 149 of 169
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-16-2021 11:53:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/16/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-16-2021 11:53:12
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADDITI
ONAL VACCINATIONInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939795
Page 150 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-17-2021 11:22:29
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/17/2021Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939796
Page 151 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Feb-17-2021 11:22:37
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Feb/17/2021Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939797
Page 152 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Feb-17-2021 11:22:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/17/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-17-2021 11:22:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Feb-17-2021 11:22:57
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939798
Page 153 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-17-2021 11:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-17-2021 11:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-17-2021 11:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/17/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-17-2021 11:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-17-2021 11:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-17-2021 11:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939799
Page 154 of 169
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Feb-17-2021 11:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Feb-17-2021 11:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Feb-17-2021 11:23:17
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939800
Page 155 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-17-2021 11:23:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-17-2021 11:23:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 03:02:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-18-2021 05:05:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-17-2021 11:23:38
(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.
Feb-17-2021 11:23:38
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/17/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021 03:02:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRGVBKInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939801
Page 156 of 169
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 03:02:09
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BRGVBKInitial Entry
5.b
Date Location User Value Reason
Feb-26-2021 03:02:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSG9YTInitial Entry
5.b Sample ID
Date Location User Value Reason
Feb-26-2021 03:02:36
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSG9YTInitial Entry
5.c
Date Location User Value Reason
Feb-26-2021 03:02:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSG9YVInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-26-2021 03:02:46
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSG9YVInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0939802
Page 157 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-17-2021 11:23:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-17-2021 11:23:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 03:01:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-18-2021 05:05:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Feb-17-2021 11:23:47
(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.
Feb-17-2021 11:23:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/17/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021 03:01:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRGVBLInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939803
Page 158 of 169
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 03:01:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BRGVBLInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939804
Page 159 of 169
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-17-2021 11:23:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-18-2021 14:35:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-18-2021 14:35:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-19-2021 00:31:26
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 14:35:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Feb-18-2021 14:35:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/17/2021 11:44Initial Entry
Feb-17-2021 22:47:27
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response
for "Dose Date Time"
is missing. Kindly
review and update.
5. Anatomical Location:
Date Location User Value Reason
Feb-18-2021 14:35:52
(UTC-08:00) Pacific TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4), 
(b) (6)
(b)(4),(b)(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939805
Page 160 of 169
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
6. Body Side:
Date Location User Value Reason
Feb-19-2021 00:32:08
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 14:35:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Feb-18-2021 14:35:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
Feb-17-2021 22:46:58
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The response
for "Body Side" is
missing. Kindly
review and update.
7. Route:
Date Location User Value Reason
Feb-18-2021 14:35:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-18-2021 14:35:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-18-2021 14:35:52
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-18-2021 14:35:52
(UTC-08:00) Pacific TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b)(4),(b)(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939806
Page 161 of 169
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Feb-17-2021 11:23:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0939807
Page 162 of 169
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021 14:22:15
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/10/2021Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939808
Page 163 of 169
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Mar-10-2021 14:22:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Mar-10-2021 14:22:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Mar-10-2021 14:22:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/10/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Mar-10-2021 14:22:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Mar-10-2021 14:22:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Mar-10-2021 14:22:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:113
Test:: Choriogonadotropin
Beta_PX113
Result:: NEGATIVEInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939809
Page 164 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Mar-10-2021 14:22:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Mar-10-2021 14:22:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Mar-10-2021 14:22:33
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939810
Page 165 of 169
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-10-2021 14:22:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-10-2021 14:22:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-10-2021 14:22:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-10-2021 14:22:43
(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.
Mar-10-2021 14:22:43
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/10/2021Initial Entry
5.a
Date Location User Value Reason
Mar-10-2021 14:22:56
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR9MPMInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-10-2021 14:22:56
(UTC-08:00) Pacific TimeACV0PFEINFP6000  Data Entry:
BR9MPMInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939811
Page 166 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0939812
Page 167 of 169
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Mar-10-2021 14:28:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Mar-10-2021 14:28:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Mar-10-2021 14:28:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Mar-10-2021 14:28:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/10/2021 10:11Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Mar-10-2021 14:28:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Mar-10-2021 14:28:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939813
Page 168 of 169
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Mar-10-2021 14:28:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Mar-10-2021 14:28:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Mar-10-2021 14:28:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Mar-10-2021 14:28:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Mar-10-2021 14:28:47
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939814
Page 169 of 169
***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: 1135 Site Name: (1135) Anaheim Clinical Trials
Subject No: 11351563 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-16-2020 16:17:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-28-2020 10:20:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-28-2020 10:13:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-18-2020 04:13:20
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Dec-17-2020 09:10:51
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered data has been entered in
EDC
Dec-17-2020 05:47:04
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020498809
acute pancreatitis 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.
Dec-16-2020 16:17:59
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/16/2020Initial Entry
Oct-28-2020 10:20:16
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/27/2020Initial Entry
Oct-28-2020 10:13:23
(UTC-08:00) Pacific Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/27/2020Initial Entry
090177e196ae3d55\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0939815