125742 S1 M5 CRF c4591001 1095 10951125

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
195
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 195
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021812
Page 2 of 195
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/24/2020
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021813
Page 3 of 195
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Demography
1.Subject ID [10951125]
2.Birth Date: /1951
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:
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021814
Page 4 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021815
Page 5 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021816
Page 6 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021817
Page 7 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Sep/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: Jun/UNK/2016
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type II diabetes]
Start Date: Nov/UNK/2014
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: Jun/UNK/2016
Ongoing: YES
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021818
Page 8 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: Mar/UNK/2020
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Alopecia]
Start Date: UNK/UNK/2014
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Urinary incontinence]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2011
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bladder suspension]
Start Date: UNK/UNK/2011
Ongoing: NO
End Date:
UNK/UNK/2011
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021819
Page 9 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleep apnea]
Start Date: Nov/UNK/2014
Ongoing: YES
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021820
Page 10 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [88.1]
3.Unit: kg
4.Height: [157.0]
5.Unit: cm
6.Body Mass Index: [35.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021821
Page 11 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/24/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021822
Page 12 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [236259]
3.Randomization Group: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021823
Page 13 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BPY2P1]
5.bSample ID [BPY2P2]
5.cSample ID [BPY2P3]
5.dSample ID [BPLJKL]
5.eSample ID [BPLJKM]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021824
Page 14 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
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 [BP3BCV]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021825
Page 15 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/24/2020 15:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021826
Page 16 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021827
Page 17 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/14/2020
2.Erroneous Visit
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021828
Page 18 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vital Signs
1.Date: Sep/14/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021829
Page 19 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021830
Page 20 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/14/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1N18]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021831
Page 21 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/14/2020 11:04
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021832
Page 22 of 195
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/12/2020
2.Erroneous Visit
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021833
Page 23 of 195
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/12/2020
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 [BP1MFR]
5.bSample ID [BP1MFS]
5.cSample ID [BP1MFT]
5.dSample ID [BPLJNP]
5.eSample ID [BPLJNR]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021834
Page 24 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021835
Page 25 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021836
Page 26 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021837
Page 27 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021838
Page 28 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021839
Page 29 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021840
Page 30 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021841
Page 31 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021842
Page 32 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021843
Page 33 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Unplanned Assessments
1.Assessments
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021844
Page 34 of 195
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/12/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021845
Page 35 of 195
***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: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021846
Page 36 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021847
Page 37 of 195
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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 [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021848
Page 38 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  right knee osteoar
thritis Sep/1/2020 UNK
:UNK YES  Repeating
Pages
 2.ADVERSE EV
ENT 2  Diplopia  Jan/8/2021 16:00  NO
End Date Time:
Jan/20/2021 UNK:UNK
 Repeating
Pages
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021849
Page 39 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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)[right knee osteoarthritis]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[mechanical stress]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021850
Page 40 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021851
Page 41 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Diplopia]
4.Start Date Time: Jan/8/2021 16:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/20/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may jeopardize
subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
Did this serious event result in death?
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
Is this serious event life threatening?
Other medically important serious event
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
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021852
Page 42 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:
[idiopathic diplopia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021046492]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021853
Page 43 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021854
Page 44 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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[ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021855
Page 45 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021856
Page 46 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: //
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021857
Page 47 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021858
Page 48 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021859
Page 49 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021860
Page 50 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021861
Page 51 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021862
Page 52 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021863
Page 53 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021864
Page 54 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021865
Page 55 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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:
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021866
Page 56 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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?
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021867
Page 57 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021868
Page 58 of 195
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021869
Page 59 of 195
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021870
Page 60 of 195
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021871
Page 61 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/28/2020
2.Erroneous Visit
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021872
Page 62 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/28/2020
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021873
Page 63 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021874
Page 64 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Dec/28/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021875
Page 65 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Done Comments
2.Lab Sub-Panel: Not Done Comments
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)Not Done
[ ]Comments
5.Specimen Type: Not Done Comments
Lab Result
6.aSponsor ID: Not Done
[ ]Comments
Test: Not Done
Choriogonadotropin Beta_PX113
Result: Not Done Comments
Not Done: Not Done Comments
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021876
Page 66 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/28/2020
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 [BP1T6L]
5.bSample ID [BP1T6M]
5.cSample ID [BP1T6N]
5.dSample ID [BPLK0T]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021877
Page 67 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/28/2020
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 [BP1NBH]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021878
Page 68 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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: Dec/28/2020 14:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021879
Page 69 of 195
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/18/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021880
Page 70 of 195
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021881
Page 71 of 195
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021882
Page 72 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021883
Page 73 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021884
Page 74 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
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 [BR0VCC]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021885
Page 75 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/18/2021 16:08
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021886
Page 76 of 195
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021887
Page 77 of 195
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/5/2021
3.Comments: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021888
Page 78 of 195
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021889
Page 79 of 195
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021890
Page 80 of 195
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021891
Page 81 of 195
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021892
Page 82 of 195
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/5/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021893
Page 83 of 195
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/12/2020
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021894
Page 84 of 195
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021895
Page 85 of 195
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021896
Page 86 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormAug-24-2020 15:57:04 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021897
Page 87 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormSep-14-2020 13:51:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021898
Page 88 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Sep-14-2020 13:51:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021899
Page 89 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Sep-14-2020 13:51:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021900
Page 90 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Sep-14-2020 13:51:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021901
Page 91 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Sep-14-2020 13:51:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021902
Page 92 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Sep-14-2020 13:51:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021903
Page 93 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-14-2020 13:51:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021904
Page 94 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-14-2020 13:51:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021905
Page 95 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aSep-14-2020 13:51:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021906
Page 96 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormDec-28-2020 16:42:35 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021907
Page 97 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
FormDec-29-2020 08:59:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021908
Page 98 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
1Dec-29-2020 08:59:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021909
Page 99 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
2Dec-29-2020 08:59:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021910
Page 100 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Dec-29-2020 08:59:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021911
Page 101 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
4Dec-29-2020 08:59:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021912
Page 102 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
5Dec-29-2020 08:59:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021913
Page 103 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aDec-29-2020 08:59:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021914
Page 104 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aDec-29-2020 08:59:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021915
Page 105 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
6.aDec-29-2020 08:59:39 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021916
Page 106 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
ItemDate User Comment
3Jan-18-2021 16:49:52 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021917
Page 107 of 195
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-04-2021 16:08:57 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell  Approved Jan-25-2021 21:27:29 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulPickrell, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Dec-21-2020 11:26:52 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Pickrell  Approved Oct-23-2020 18:52:28 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021918
Page 108 of 195
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Affidavit:
By my dated signature below, I, PaulPickrell, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1021919
Page 109 of 195
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-24-2020 15:44:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-24-2020 15:44:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021920
Page 110 of 195
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-24-2020 15:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/24/2020Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021921
Page 111 of 195
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020 15:43:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10951125Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020 15:43:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-24-2020 15:44:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-24-2020 15:44:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-24-2020 15:44:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021922
Page 112 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-24-2020 15:44:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021923
Page 113 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-24-2020 15:45:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-24-2020 15:45:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-24-2020 15:45:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021924
Page 114 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020 15:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Hypertensio
n
Start Date: Sep/UNK/2
016
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-24-2020 15:46:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/UNK/2016Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-24-2020 15:46:56
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-1021925
Page 115 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
1.b
Date Location User Value Reason
Aug-24-2020 15:47:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Hyperlipide
mia
Start Date: Jun/UNK/2
016
Ongoing: YESInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021926
Page 116 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.b Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:47:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:47:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HyperlipidemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-24-2020 15:47:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-24-2020 15:47:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-24-2020 15:47:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Type II diab
etes
Start Date: Nov/UNK/2
014
Ongoing: YESInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021927
Page 117 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.c Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:47:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:47:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type II diabetesInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-24-2020 15:47:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/UNK/2014Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-24-2020 15:47:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-24-2020 15:48:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Depression
Start Date: Jun/UNK/2
016
Ongoing: YESInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021928
Page 118 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.d Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:48:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:48:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DepressionInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-24-2020 15:48:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-24-2020 15:48:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-24-2020 15:49:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Hypothyroid
ism
Start Date: Mar/UNK/2
020
Ongoing: YESInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021929
Page 119 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.e Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:49:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:49:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypothyroidismInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-24-2020 15:49:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/UNK/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-24-2020 15:49:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-24-2020 15:50:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:Alopecia
Start Date: UNK/UNK/
2014
Ongoing: YESInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021930
Page 120 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.f Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:50:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:50:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AlopeciaInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-24-2020 15:50:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-24-2020 15:50:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-24-2020 15:50:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:Urinary inconti
nence
Start Date: UNK/UNK/20
05Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021931
Page 121 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Ongoing: NO
End Date:
UNK/UNK/
2011
1.g Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:50:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:50:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Urinary incontinenceInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-24-2020 15:50:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-24-2020 15:50:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
1.h
Date Location User Value Reason
Aug-24-2020 15:51:49
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb 8Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021932
Page 122 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada) er:
Medical History
Term:Bladder suspe
nsion
Start Date: UNK/UNK/20
11
Ongoing: NO
End Date:
UNK/UNK
/2011
1.h Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:51:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:51:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Bladder suspensionInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-24-2020 15:51:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2011Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-24-2020 15:51:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2011Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021933
Page 123 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
1.i
Date Location User Value Reason
Aug-24-2020 15:52:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:Sleep apnea
Start Date: Nov/UNK/2
014
Ongoing: YESInitial Entry
1.i Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:52:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:52:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sleep apneaInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-24-2020 15:52:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/UNK/2014Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-24-2020 15:52:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021934
Page 124 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Aug-24-2020 15:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-24-2020 15:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
88.1Initial Entry
3. Unit:
Date Location User Value Reason
Aug-24-2020 15:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-24-2020 15:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
157.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-24-2020 15:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1021935
Page 125 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-24-2020 15:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35.7Initial Entry
7.a
Date Location User Value Reason
Aug-24-2020 15:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.8
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-24-2020 15:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-24-2020 15:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-24-2020 15:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021936
Page 126 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-24-2020 15:52:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021937
Page 127 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-24-2020 15:53:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-24-2020 15:53:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-24-2020 15:53:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-24-2020 15:53:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-24-2020 15:53:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021938
Page 128 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-24-2020 15:53:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-24-2020 15:53:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-24-2020 15:53:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-24-2020 15:53:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021939
Page 129 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-24-2020 15:53:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-24-2020 15:53:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
236259Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021940
Page 130 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020 15:54:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 15:54:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-15-2020 01:56:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Sep-14-2020 15:51:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered this has been
updated
Sep-11-2020 22:12:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: Barcode
BPLJKL BPLJKM
is missing in
inform. Please
review and update
accordingly or
clarify.
Aug-25-2020 12:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-25-2020 08:25:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021941
Page 131 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
barcodes are
entered. Please
review and correct
as appropriate.
Aug-24-2020 15:54:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-24-2020 15:54:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-25-2020 12:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY2P1Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-25-2020 12:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY2P1Initial Entry
5.b
Date Location User Value Reason
Aug-25-2020 12:26:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY2P2Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021942
Page 132 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
5.b Sample ID
Date Location User Value Reason
Aug-25-2020 12:26:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY2P2Initial Entry
5.c
Date Location User Value Reason
Aug-25-2020 12:27:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY2P3Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-25-2020 12:27:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY2P3Initial Entry
5.d
Date Location User Value Reason
Sep-14-2020 15:50:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLJKLInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-14-2020 15:50:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLJKLInitial Entry
5.e
Date Location User Value Reason
Sep-14-2020 15:50:50
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Sample ID: BPLJKMInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1021943
Page 133 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
5.e Sample ID
Date Location User Value Reason
Sep-14-2020 15:50:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLJKMInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021944
Page 134 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020 15:54:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 15:54:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-25-2020 12:27:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-25-2020 08:25:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-24-2020 15:54:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-24-2020 15:54:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-1021945
Page 135 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug/24/2020
5.a
Date Location User Value Reason
Aug-25-2020 12:27:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3BCVInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-25-2020 12:27:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3BCVInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021946
Page 136 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-24-2020 15:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-24-2020 15:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020 15:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-24-2020 15:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020 15:01Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-24-2020 15:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021947
Page 137 of 195
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Aug-24-2020 15:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-24-2020 15:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-24-2020 15:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-24-2020 15:54:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021948
Page 138 of 195
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-24-2020 15:55:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021949
Page 139 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-14-2020 13:49:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021950
Page 140 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date:
Date Location User Value Reason
Sep-14-2020 13:50:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020Initial Entry
2.a
Date Location User Value Reason
Sep-14-2020 13:50:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.7
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-14-2020 13:50:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-14-2020 13:50:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-14-2020 13:50:17
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1021951
Page 141 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Sep-14-2020 13:50:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021952
Page 142 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-14-2020 13:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-14-2020 13:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-14-2020 13:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-14-2020 13:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-14-2020 13:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1021953
Page 143 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-14-2020 13:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-14-2020 13:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-14-2020 13:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-14-2020 13:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-14-2020 13:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1021954
Page 144 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-14-2020 13:51:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-14-2020 13:51:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020 16:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-14-2020 13:51:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-14-2020 13:51:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/14/2020Initial Entry
5.a
Date Location User Value Reason
Sep-14-2020 16:02:50
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Sample ID: BP1N18Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1021955
Page 145 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Sep-14-2020 16:02:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1N18Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021956
Page 146 of 195
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-14-2020 13:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-14-2020 13:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-14-2020 13:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-14-2020 13:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/14/2020 11:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-14-2020 13:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021957
Page 147 of 195
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Sep-14-2020 13:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-14-2020 13:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-14-2020 13:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-14-2020 13:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021958
Page 148 of 195
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-12-2020 10:19:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1021959
Page 149 of 195
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 10:28:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 10:28:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 19:01:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 10:28:51
(UTC-06:00) Central
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-12-2020 10:28:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/12/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020 19:01:34 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1021960
Page 150 of 195
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US & Canada)Sample ID: BP1MFR
5.a Sample ID
Date Location User Value Reason
Oct-12-2020 19:01:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1MFRInitial Entry
5.b
Date Location User Value Reason
Oct-12-2020 19:01:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1MFSInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-12-2020 19:01:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1MFSInitial Entry
5.c
Date Location User Value Reason
Oct-12-2020 19:02:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1MFTInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-12-2020 19:02:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1MFTInitial Entry
5.d
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1021961
Page 151 of 195
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Oct-12-2020 19:02:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLJNPInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-12-2020 19:02:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLJNPInitial Entry
5.e
Date Location User Value Reason
Oct-12-2020 19:02:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLJNRInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-12-2020 19:02:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLJNRInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1021962
Page 152 of 195
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-12-2020 10:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-12-2020 10:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-12-2020 10:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1021963
Page 153 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1021964
Page 154 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
Date Location User Value Reason
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1021965
Page 155 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-28-2020 16:47:28
(UTC-06:00) Central
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
Feb-08-2021 09:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-04-2021 16:09:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered This has been
added
Jan-23-2021 14:49:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical - Subject
has a SAE report
(#2021046492) for
an event 'Diplopia';
please enter the
event on the AE
CRF
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right knee osteoarthritisInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1021966
Page 156 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial 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-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1021967
Page 157 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Dec-30-2020 00:00:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-29-2020 10:09:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Dec-29-2020 10:09:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
mechanical stressTranscription Error
Dec-29-2020 02:34:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
consider updating
'If Not Related to
study treatment(s)'
missing field.
Thank you.
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1021968
Page 158 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-28-2020 16:47:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-1021969
Page 159 of 195
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Category:
Date Location User Value Reason
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DiplopiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 15:40:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-08-2021 16:54:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-08-2021 16:54:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021 16:00New Information
Feb-08-2021 14:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Start date
is 15Jan21;
however, SAE
report start date is
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1021970
Page 160 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
08Jan21. Please
review Start date
for this
intermittent event
(report 1st
episode),
harmonize
reporting, update
where appropriate
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/15/2021 16:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 20:34:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-21-2021 11:35:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-21-2021 11:35:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/20/2021 UNK:UNKNew Information
Feb-16-2021 15:43:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL Please
submit End date to
AE/SAE report, if
available, and
update status to
Resolved
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1021971
Page 161 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial 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
Feb-16-2021
15:40:44
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Query 4: Closed serious criterion selected
Feb-16-2021
15:39:37
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Feb-15-2021
07:47:40
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Query 4: Reissued:Ope
nedClosed per data updated.
Feb-15-2021
03:30:16
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies query
Feb-12-2021
17:49:24
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Query 4: Answered This has been updated
Feb-12-2021
17:48:34ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened Is this adverse event
serious?' is reported 'Yes',
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1021972
Page 162 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US &
Canada)but at least one seriousness
criteria is missing. Please
review and update as
appropriate.
Feb-12-2021
17:48:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Feb-12-2021
17:48:34
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Did this serious event
require or prolong hos
pitalization?
YESTranscription Error
Feb-10-2021
21:07:17
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Query 3: Opened SAE
RECON:AER#2021046492
Diplopia(onset
date:15Jan2021)was
reported as serious in
Safety database but
downgraded to non serious
in AE CRF. Please confirm
seriousness. If safety
update is required, submit a
follow-up SAE Form.
Feb-09-2021
22:04:36
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be addressed
internally
Feb-08-2021
16:52:18
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Query 2: Answered This was submitted on 04
Feb 2021
Feb-08-2021
14:41:16
(UTC-06:00) CentralACV0PFEINFP6000  Query 2: Opened Clinical Serious criteria for
event Diplopia is NO;
however, SAE report
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1021973
Page 163 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US &
Canada)#2021046492 was
submitted for this event (&
SAE # still on AE CRF).
Please clarify if event is
SAE. If SAE, update here /
if no longer SAE, send
updated form to Safety
Feb-08-2021
08:09:57
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Diplopia: Response
to "Is the adverse event
serious?" is 'No' but
"Serious Adverse Event
Number" is present.
Feb-04-2021
16:08:57
(UTC-06:00) Central
Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
idiopathic diplopiaInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1021974
Page 164 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-15-2021 12:06:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Feb-12-2021 17:53:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-12-2021 17:53:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Feb-10-2021 17:00:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify in the
answer what
non-drug treatment
was given.
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-02-2021
05:08:15
(UTC-06:00)ACV0PFEINFP6000  Query 2: Closed SDB updated
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-1021975
Page 165 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Central Time (US
& Canada)
Feb-26-2021
00:49:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Reissue
d:OpenedSA RECON:Per latest SAE listing,
last follow up date is 04Feb2021.
Please confirm if follow up SAE
form was submitted to update
outcome to recovered/resolved in
Safety database.
Feb-25-2021
12:49:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answer
edThis has been updated and emailed
Feb-23-2021
22:45:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2021046492 ,outcome
was updated to
RECOVERED/RESOLVED on AE
CRF while reported as
Recovering/Resolving in Safety
database. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Feb-21-2021
11:36:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-21-2021
11:36:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/R
ESOLVEDupdated
Feb-21-2021
11:35:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Diplopia: Response to
"What was the outcome of this
adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Feb-04-2021
16:08:57ACV0PFEINFP6000  Data Entry:
RECOVERING/Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1021976
Page 166 of 195
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00)
Central Time (US
& Canada)RESOLVING
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-04-2021 16:08:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-08-2021 08:09:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021046492Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-1021977
Page 167 of 195
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-21-2020 11:26:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/18/2020Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021978
Page 168 of 195
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Dec-22-2020 13:21:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-22-2020 04:25:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened The response
indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Dec-21-2020 11:27:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded, however
the TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Dec-21-2020 11:27:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible per local/national r
ecommendations and confi
rmed to have received onl
y placebo at Vaccination 1
/2Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021979
Page 169 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-28-2020 16:42:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/28/2020Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021980
Page 170 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Consent Was:
Date Location User Value Reason
Dec-28-2020 16:42:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/28/2020Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021981
Page 171 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-29-2020 08:57:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/28/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-29-2020 08:57:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Dec-29-2020 08:57:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021982
Page 172 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Lab Panel:
Date Location User Value Reason
Dec-29-2020 08:59:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Dec-29-2020 08:59:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Collection Date:
Date Location User Value Reason
Dec-29-2020 08:59:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Dec-29-2020 08:59:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Specimen Type:
Date Location User Value Reason
Dec-29-2020 08:59:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1021983
Page 173 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Dec-29-2020 08:59:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ide
ntifier:Not Do
ne
Test:: Not Do
ne
Result:: Not Do
ne
Not Done:: Not Do
neInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Dec-29-2020 08:59:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Test:
Date Location User Value Reason
Dec-29-2020 08:59:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Result:
Date Location User Value Reason
Dec-29-2020 08:59:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a Not Done:
Date Location User Value Reason
Dec-29-2020 08:59:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1021984
Page 174 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-29-2020 09:00:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-29-2020 09:00:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-29-2020 09:09:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-29-2020 09:00:00
(UTC-06:00) Central
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-29-2020 09:00:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/28/2020Initial Entry
5.a
Date Location User Value Reason
Dec-29-2020 09:09:12 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1021985
Page 175 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US & Canada)Sample ID: BP1T6L
5.a Sample ID
Date Location User Value Reason
Dec-29-2020 09:09:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1T6LInitial Entry
5.b
Date Location User Value Reason
Dec-29-2020 09:09:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1T6MInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-29-2020 09:09:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1T6MInitial Entry
5.c
Date Location User Value Reason
Dec-29-2020 09:09:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1T6NInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-29-2020 09:09:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1T6NInitial Entry
5.d
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (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-2021-5683-1021986
Page 176 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Date Location User Value Reason
Dec-29-2020 09:09:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLK0TInitial Entry
5.d Sample ID
Date Location User Value Reason
Dec-29-2020 09:09:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLK0TInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021987
Page 177 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-29-2020 09:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-29-2020 09:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-29-2020 09:01:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-29-2020 09:00:38
(UTC-06:00) Central
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-29-2020 09:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/28/2020Initial Entry
5.a
Date Location User Value Reason
Dec-29-2020 09:01:48 ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1021988
Page 178 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US & Canada)Sample ID: BP1NBH
Dec-29-2020 09:01:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1T6LInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-29-2020 09:01:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1NBHTranscription Error
Dec-29-2020 09:01:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1T6LInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021989
Page 179 of 195
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Dec-29-2020 09:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Dec-29-2020 09:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Dec-29-2020 09:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Dec-29-2020 09:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/28/2020 14:01Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Dec-29-2020 09:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021990
Page 180 of 195
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Dec-29-2020 09:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Dec-29-2020 09:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Dec-29-2020 09:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Dec-29-2020 09:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Dec-29-2020 09:10:33
(UTC-06:00) Central
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
Dec-29-2020 09:10:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021991
Page 181 of 195
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-22-2020 13:21:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/18/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-22-2020 13:21:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATIO
NInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021992
Page 182 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-18-2021 16:49:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/18/2021Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021993
Page 183 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
3. Collection Date:
Date Location User Value Reason
Jan-18-2021 16:49:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Jan-18-2021 16:50:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifie
r:113
Test:: Choriogonadotr
opin Beta_PX1
13
Result::
Not Done:: NOT DONEInitial Entry
Jan-18-2021 16:49:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defi
ned Identifie
r:
Test:: Choriogonadotr
opin Beta_PX1
13
Result::
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-18-2021 16:50:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021994
Page 184 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
6.a Test:
Date Location User Value Reason
Jan-18-2021 16:49:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Jan-18-2021 16:50:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021995
Page 185 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-18-2021 16:50:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-18-2021 16:50:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-18-2021 17:24:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-18-2021 16:50:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-18-2021 16:50:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/18/2021Initial Entry
5.a
Date Location User Value Reason
Jan-18-2021 17:24:56 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-1021996
Page 186 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
(UTC-06:00) Central
Time (US & Canada)Sample ID: BR0VCC
5.a Sample ID
Date Location User Value Reason
Jan-18-2021 17:24:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR0VCCInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021997
Page 187 of 195
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-18-2021 16:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-18-2021 16:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-18-2021 16:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-18-2021 16:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/18/2021 16:08Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-18-2021 16:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021998
Page 188 of 195
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Jan-18-2021 16:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-18-2021 16:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-18-2021 16:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-18-2021 16:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-18-2021 16:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-18-2021 16:50:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1021999
Page 189 of 195
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Visit
Date Location User ValueReason
Mar-09-2021
22:37:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedClosed per SITE
response, added
to PD tracker for
Clinical Review
Mar-09-2021
15:21:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dsite was closed
due to severe
weather and we
did not have IP
when we
returned
Mar-08-2021
23:42:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of
visit
V103_MONTH1
is out of window
for 11 days from
V102_VAX4
DOV or
Vaccination date.
Please verify and
update. Else,
confirm in query
response
appropriately.
Mar-05-2021
08:55:28
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Mar/5
/2021Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1022000
Page 190 of 195
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-05-2021 08:55:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-05-2021 08:55:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Mar/5/2021Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022001
Page 191 of 195
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-05-2021 08:56:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/5/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-05-2021 08:56:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-11-2021 09:17:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-11-2021 08:32:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Mar-11-2021 08:32:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to
"Status" is
COMPLETED but
"Specify Status" is
Provided.
Mar-11-2021 08:32:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Mar-11-2021 08:32:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDTranscription Error
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022002
Page 192 of 195
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Mar-11-2021 00:19:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clin: Per response,
please update.
Mar-10-2021 19:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Clin: Per response,
please update.
Mar-10-2021 15:27:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Please unfreeze and
requery. Answered
incorrectly
Mar-10-2021 07:37:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clin: Please clarify
what the protocol
deviation was so
this can be
reported.
Mar-05-2021 08:56:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PROTOCOL DEVIATIONInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-11-2021 08:32:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-05-2021 08:56:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Site was closed due to severe
weatherInitial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022003
Page 193 of 195
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-12-2020 10:29:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-24-2020 15:53:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-24-2020 15:45:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-08-2021
14:18:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed SAE reported on AE CRF
Feb-04-2021
16:10:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered This was added and at this
time no new information to
collect
Jan-25-2021
07:03:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021046492
Diplopia(onset
date:15Jan2021)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-12-2020
10:29:05
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/12/2020Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-1022004
Page 194 of 195
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
Time (US & Canada)
Aug-24-2020
15:53:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/24/2020Initial Entry
Aug-24-2020
15:45:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/24/2020Initial Entry
090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-1022005
Page 195 of 195
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1095 Site Name: (1095) Tekton Research
Subject No: 10951125 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:39
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1. Casebook Signature
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Oct-23-2020 18:27:00
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090177e196ae2fba\Final\Final On: 01-Apr-2021 03:49 (GMT)
(b) 
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(b) (4)
FDA-CBER-2021-5683-1022006
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