125742 S1 M5 CRF c4591001 1168 11681083

Document text

Page 1 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814571
Page 2 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/25/2020
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814572
Page 3 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11681083]
2.Birth Date: 1955
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814573
Page 4 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814574
Page 5 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814575
Page 6 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/25/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814576
Page 7 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RINGING IN EARS]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SEASONAL ALLERGIES]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BILATERAL OSTEOARTHRITIS(KNEE)]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS(NECK)]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814577
Page 8 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[JOINT PAIN(SPINE)]
Start Date: UNK/UNK/2010
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BASAL CELL CARCINOMA (FOREHEAD)]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CERVICAL SPINAL FUSION]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814578
Page 9 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/25/2020
2.Weight: [96.8]
3.Unit: kg
4.Height: [185.5]
5.Unit: cm
6.Body Mass Index: [28.1]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814579
Page 10 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/25/2020
2.Randomization Number: [239984]
3.Randomization Group: [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814580
Page 11 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
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 [BPY82G]
5.bSample ID [BPY82H]
5.cSample ID [BPY82J]
5.dSample ID [BNW822]
5.eSample ID [BNW823]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814581
Page 12 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
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 [BPY82F]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814582
Page 13 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/25/2020 12:53
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
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814583
Page 14 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814584
Page 15 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814585
Page 16 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814586
Page 17 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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 [BPT5DH]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814587
Page 18 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/15/2020 11:42
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
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814588
Page 19 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814589
Page 20 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/16/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8SSN]
5.bSample ID [BRTRHP]
5.cSample ID [BRTRHR]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814590
Page 21 of 124
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814591
Page 22 of 124
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814592
Page 23 of 124
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814593
Page 24 of 124
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814594
Page 25 of 124
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814595
Page 26 of 124
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814596
Page 27 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814597
Page 28 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814598
Page 29 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814599
Page 30 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814600
Page 31 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814601
Page 32 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814602
Page 33 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814603
Page 34 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814604
Page 35 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814605
Page 36 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Unplanned Assessments
1.Assessments
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814606
Page 37 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/16/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814607
Page 38 of 124
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
:Nov/18/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: DEATH
4.Specify Status: [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814608
Page 39 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814609
Page 40 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814610
Page 41 of 124
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Identif
ierAdverse Ev
entStart DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EVE
NT 1  Aortic Rupt
ure Nov/18/2020 UNK:
UNK NO
End Date Time:
Nov/18/2020 UNK:UNK
 Repeating
Pages
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814611
Page 42 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Aortic Rupture]
4.Start Date Time: Nov/18/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/18/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
YES
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
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
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814612
Page 43 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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:
[Aortic Rupture]
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?:FATAL
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number:
For Pfizer Use Only[2020459587]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814613
Page 44 of 124
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814614
Page 45 of 124
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814615
Page 46 of 124
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814616
Page 47 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: //
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814617
Page 48 of 124
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814618
Page 49 of 124
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814619
Page 50 of 124
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814620
Page 51 of 124
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814621
Page 52 of 124
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814622
Page 53 of 124
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814623
Page 54 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814624
Page 55 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814625
Page 56 of 124
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814626
Page 57 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814627
Page 58 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814628
Page 59 of 124
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814629
Page 60 of 124
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814630
Page 61 of 124
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814631
Page 62 of 124
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814632
Page 63 of 124
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814633
Page 64 of 124
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814634
Page 65 of 124
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814635
Page 66 of 124
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814636
Page 67 of 124
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Nov/19/2020
Cause of Death
2.aCause of Death Status: PRIMARY CAUSE OF DEATH
Cause of Death: [Aortic Rupture]
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814637
Page 68 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/18/2020
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814638
Page 69 of 124
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814639
Page 70 of 124
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Steven Cox  Approved Nov-23-2020 08:20:34 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StevenCox, 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.
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814640
Page 71 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormAug-26-2020 10:47:46 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814641
Page 72 of 124
***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, Signed, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Steven Cox  Approved Nov-23-2020 08:20:34 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StevenCox, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-19-2020 16:16:34 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Steven Cox  Approved Oct-23-2020 09:36:50 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, StevenCox, 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.
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814642
Page 73 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-26-2020 10:45:47
(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-26-2020 10:45:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814643
Page 74 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-26-2020 10:46:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/25/2020Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814644
Page 75 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-26-2020 10:45:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11681083Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-26-2020 10:45:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1955Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-26-2020 10:47:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-26-2020 10:47:24
(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-26-2020 10:47:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814645
Page 76 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-26-2020 10:47:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814646
Page 77 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-26-2020 10:48:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-26-2020 10:48:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-26-2020 10:48:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814647
Page 78 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-26-2020 10:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:RINGING IN
EARS
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-26-2020 10:52:15
(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-26-2020 10:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RINGING IN EARSInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-26-2020 10:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-26-2020 10:52:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814648
Page 79 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b
Date Location User Value Reason
Aug-26-2020 10:54:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histo
ry Term:SEASONAL AL
LERGIES
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-26-2020 10:54:52
(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-26-2020 10:54:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SEASONAL ALLERGIESInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-26-2020 10:54:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-26-2020 10:54:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814649
Page 80 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-26-2020 10:57:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical Hi
story Term
:BILATERAL OSTE
OARTHRITIS(KNE
E)
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-26-2020 10:57:56
(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-26-2020 10:57:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BILATERAL OSTEOARTHRITI
S(KNEE)Initial Entry
1.c Start Date:
Date Location User Value Reason
Aug-26-2020 10:57:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-26-2020 10:57:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-26-2020 10:59:16 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814650
Page 81 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Nu
mber:4
Medical Histo
ry Term:OSTEOARTHRI
TIS(NECK)
Start Date: UNK/UNK/2010
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-26-2020 10:59:16
(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-26-2020 10:59:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OSTEOARTHRITIS(NECK)Initial Entry
1.d Start Date:
Date Location User Value Reason
Aug-26-2020 10:59:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-26-2020 10:59:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-26-2020 11:01:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814651
Page 82 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Medical History
Term:JOINT PAIN(S
PINE)
Start Date: UNK/UNK/20
10
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-26-2020 11:01:03
(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-26-2020 11:01:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
JOINT PAIN(SPINE)Initial Entry
1.e Start Date:
Date Location User Value Reason
Aug-26-2020 11:01:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-26-2020 11:01:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-27-2020 08:39:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:6Transcription Error
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814652
Page 83 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Medical
History T
erm:BASAL CELL CAR
CINOMA (FOREHE
AD)
Start Date
:UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2015
Aug-26-2020 11:02:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:BASAL CELL(F
OREHEAD)
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/20
15Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814653
Page 84 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.f Line/MH Number:
Date Location User Value Reason
Aug-26-2020 11:02:40
(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-27-2020
14:43:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1:
ClosedDiscrepancy has
been closed.
Aug-27-2020
08:39:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
AnsweredTranscription Error
Aug-27-2020
08:39:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
BASAL
CELL CA
RCINOM
A (FORE
HEAD)Transcription Error
Aug-26-2020
18:47:02
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1:
OpenedClarify BASAL
CELL(FOREHEAD)
as follows...Term is
unclear. Are you
reporting BASAL
CELL
CARCINOMA
(FOREHEAD)? Or
BASAL CELL
SKIN LESION? Or
other? Please update
the verbatim term to
clarify. Thank you.
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0814654
Page 85 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-26-2020
11:02:40
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data Ent
ry:
BASAL
CELL(FO
REHEAD
)Initial Entry
1.f Start Date:
Date Location User Value Reason
Aug-26-2020 11:02:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-26-2020 11:02:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2015Initial Entry
1.g
Date Location User Value Reason
Aug-26-2020 11:04:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:CERVICAL SPIN
AL FUSION
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/201
3Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814655
Page 86 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.g Line/MH Number:
Date Location User Value Reason
Aug-26-2020 11:04:33
(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-26-2020 11:04:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CERVICAL SPINAL FUSIONInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-26-2020 11:04:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-26-2020 11:04:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814656
Page 87 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-26-2020 11:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-26-2020 11:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
96.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-26-2020 11:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-26-2020 11:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
185.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-26-2020 11:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-26-2020 11:05:37 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0814657
Page 88 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)(autocalc) 28.1
7.a
Date Location User Value Reason
Aug-26-2020 11:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 97.7
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-26-2020 11:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-26-2020 11:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-26-2020 11:05:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-26-2020 11:05:37
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814658
Page 89 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0814659
Page 90 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-26-2020 11:06:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-26-2020 11:06:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
239984Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814660
Page 91 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 11:06:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 11:06:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-26-2020 12:48:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-26-2020 11:06:47
(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-26-2020 11:06:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020 12:48:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY82GInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814661
Page 92 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 12:48:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY82GInitial Entry
5.b
Date Location User Value Reason
Aug-26-2020 12:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY82HInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-26-2020 12:48:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY82HInitial Entry
5.c
Date Location User Value Reason
Aug-26-2020 12:48:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY82JInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-26-2020 12:48:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY82JInitial Entry
5.d
Date Location User Value Reason
Aug-26-2020 12:49:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW822Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0814662
Page 93 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.d Sample ID
Date Location User Value Reason
Aug-26-2020 12:49:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW822Initial Entry
5.e
Date Location User Value Reason
Aug-26-2020 12:49:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNW823Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-26-2020 12:49:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNW823Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814663
Page 94 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-26-2020 11:06:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-26-2020 11:06:55
(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-26-2020 12:48:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-26-2020 11:06:55
(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-26-2020 11:06:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/25/2020Initial Entry
5.a
Date Location User Value Reason
Aug-26-2020 12:48:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY82FInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814664
Page 95 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Aug-26-2020 12:48:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY82FInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814665
Page 96 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-26-2020 11:07:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-26-2020 11:07:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-26-2020 11:07:42
(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-26-2020 11:07:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020 12:53Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-26-2020 11:07:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-26-2020 11:07:42 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814666
Page 97 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)LEFT
7. Route:
Date Location User Value Reason
Aug-26-2020 11:07:42
(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-26-2020 11:07:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-26-2020 11:07:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814667
Page 98 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-26-2020 11:09:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814668
Page 99 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-15-2020 15:11:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814669
Page 100 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020 15:12:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-15-2020 15:12:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 97.8
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-15-2020 15:12:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-15-2020 15:12:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.8Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-15-2020 15:12:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0814670
Page 101 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.a Temperature Location:
Date Location User Value Reason
Sep-15-2020 15:12:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814671
Page 102 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 15:12:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 15:12:08
(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-16-2020 08:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-16-2020 04:45:42
(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.
Sep-15-2020 15:12:08
(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-15-2020 15:12:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814672
Page 103 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a
Date Location User Value Reason
Sep-16-2020 08:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT5DHInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 08:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPT5DHInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814673
Page 104 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-15-2020 15:13:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-15-2020 15:13:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-15-2020 15:13:37
(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-15-2020 15:13:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/15/2020 11:42Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-15-2020 15:13:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-15-2020 15:13:37 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814674
Page 105 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)LEFT
7. Route:
Date Location User Value Reason
Sep-15-2020 15:13:37
(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-15-2020 15:13:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-15-2020 15:13:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814675
Page 106 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020 11:36:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814676
Page 107 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 11:37:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 11:37:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-19-2020 08:05:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-19-2020 05:42:37
(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.
Oct-16-2020 11:37:03
(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-16-2020 11:37:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/16/2020Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814677
Page 108 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a
Date Location User Value Reason
Oct-19-2020 08:05:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8SSNInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-19-2020 08:05:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8SSNInitial Entry
5.b
Date Location User Value Reason
Oct-19-2020 08:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTRHPInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-19-2020 08:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTRHPInitial Entry
5.c
Date Location User Value Reason
Oct-19-2020 08:05:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTRHRInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-19-2020 08:05:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTRHRInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0814678
Page 109 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-16-2020 11:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020 11:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020 11:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814679
Page 110 of 124
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-19-2020 16:18:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-19-2020 16:18:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-19-2020 16:27:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-19-2020 16:18:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-19-2020 16:18:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to
"Status" is DEATH
but "Specify
Status" is Provided.
Nov-19-2020 16:18:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Response to
'Status' is 'Death' on
Disposition- Folow
up, but 'Death' CRF
is not yet initiated.
Please review and
update as
appropriate.
Nov-19-2020 16:18:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DEATHInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814680
Page 111 of 124
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4. Specify Status:
Date Location User Value Reason
Nov-19-2020 16:18:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Changed
Information
Nov-19-2020 16:18:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
unknown cause of deathInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814681
Page 112 of 124
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Date Location User Value Reason
Nov-19-2020 16:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814682
Page 113 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Category:
Date Location User Value Reason
Nov-19-2020 16:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-19-2020 16:16:34
(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 ValueReason
Nov-20-2020
14:16:53
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_AE001_05
Nov-20-2020
09:49:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Aortic
Ruptu
reNew Information
Nov-20-2020
08:40:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dThe cause of death
is not yet known.
The information
will be updated as
soon as it is
available
Nov-19-2020
20:16:43
(UTC-06:00)
Central TimeACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW5428997;This
'Adverse Event'
contains the term
DEATH. If known,
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0814683
Page 114 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(US &
Canada)please provide the
cause of death as
the AE term with an
outcome of FATAL
or clarify.
Nov-19-2020
16:16:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
unkno
wn ca
use of
deathInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-19-2020 16:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/18/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-19-2020 16:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Nov/18/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-19-2020 16:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814684
Page 115 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-20-2020 04:06:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-19-2020 16:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE unknown
cause of death:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-19-2020 16:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
YES
Did this serious event require o
r prolong hospitalization?
NO
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous eventInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814685
Page 116 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-19-2020 16:16:34
(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
Nov-20-2020 09:50:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
Aortic RuptureNew Information
Nov-20-2020 08:42:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
unknown diagnosisChanged
Information
Nov-19-2020 16:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814686
Page 117 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
unknown cause at this tim
e
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-19-2020 16:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-19-2020 16:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-19-2020 16:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Nov-23-2020
01:02:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedClosed as data
updated.
Nov-20-2020
08:43:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredDeath DTL has
been completed
Nov-19-2020
22:34:24
(UTC-06:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Ope
nedDMW5428959;The
outcome of this AE
is selected as
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0814687
Page 118 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Central Time
(US &
Canada)FATAL, but there
are no Disposition
eCRFs with a
'Status' of DEATH.
Please review and
update as
appropriate.
Nov-19-2020
16:27:46
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Clo
sedClose Auto Query
Nov-19-2020
16:16:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ope
nedResponse to "What
was the outcome of
this adverse
event?" is 'Fatal'
but Date of
Collection /
Notification of
Death on the Death
Details form is not
completed. Please
review and update
as appropriate.
Nov-19-2020
16:16:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
FATA
LInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-19-2020 16:23:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESChanged
Information
Nov-19-2020 16:16:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814688
Page 119 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-20-2020 04:06:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020459587Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814689
Page 120 of 124
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Nov-19-2020
23:53:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-19-2020
16:28:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The site was notified the
day after the subject died
Nov-19-2020
16:27:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of Collection /
Notification of Death is
greater than the Date of
Completion/Discontinuation
/Death on the Disposition
form 18/Nov/2020. Please
review and update as
appropriate
Nov-19-2020
16:27:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020Initial Entry
2.a
Date Location User Value Reason
Nov-20-2020 09:50:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cause of De
ath Status:PRIMARY CAU
SE OF DEATH
Cause of De
ath:Aortic RuptureNew Information
Nov-20-2020 08:41:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cause of De
ath Status:PRIMARY CAU
SE OF DEATH
Cause of De
ath:unknown diagnos
isChanged
Information
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0814690
Page 121 of 124
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-19-2020 16:28:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cause of De
ath Status:PRIMARY CAU
SE OF DEATH
Cause of De
ath:unknownInitial Entry
2.a Cause of Death Status:
Date Location User Value Reason
Nov-19-2020 16:28:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CAUSE OF DEATHInitial Entry
2.a Cause of Death:
Date Location User Value Reason
Nov-20-2020
09:58:08
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Cl
osedDiscrepancy has
been closed.
Nov-20-2020
09:50:34
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Aortic Rupt
ureNew Information
Nov-20-2020
08:41:46
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: An
sweredChanged
Information
Nov-20-2020
08:41:46
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
unknown di
agnosisChanged
Information
Nov-19-2020
20:35:49
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Op
enedClarify
UNKNOWN as
follow...Term
appears
incomplete. Are
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0814691
Page 122 of 124
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
you reporting
UNKNOWN
DIAGNOSIS?
UNKNOWN
DIAGNOSTIC
PROCEDURE?
UNKNOWN
THERAPEUTIC
PROCEDURE?
Please edit and
clarify further.
Thank you.
Nov-19-2020
16:28:22
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
unknownInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0814692
Page 123 of 124
***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: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-19-2020 16:18:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Oct-16-2020 11:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-26-2020 11:06:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-26-2020 10:48:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-19-2020 16:18:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/18/2020Initial Entry
Oct-16-2020 11:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/16/2020Initial Entry
Aug-26-2020 11:06:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
Aug-26-2020 10:48:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/25/2020Initial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0814693
Page 124 of 124
***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, Signed, Verified
Site No: 1168 Site Name: (1168) Lynn Health Science Institute
Subject No: 11681083 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-22-2020 17:56:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae40d1\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0814694