125742 S1 M5 CRF c4591001 1021 10211190

Document text

Page 1 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899034
Page 2 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/10/2020
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899035
Page 3 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10211190]
2.Birth Date: 1954
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899036
Page 4 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899037
Page 5 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899038
Page 6 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899039
Page 7 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergic Rhinitis]
Start Date: UNK/UNK/1979
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal Reflux Disease]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post Menopausal]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899040
Page 8 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillitis]
Start Date: UNK/UNK/1959
Ongoing: NO
End Date:
UNK/UNK/1959
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillectomy]
Start Date: UNK/UNK/1959
Ongoing: NO
End Date:
UNK/UNK/1959
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899041
Page 9 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
2.Weight: [67.7]
3.Unit: kg
4.Height: [154.0]
5.Unit: cm
6.Body Mass Index: [28.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899042
Page 10 of 163
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899043
Page 11 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [257393]
3.Randomization Group: [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899044
Page 12 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP9D5R]
5.bSample ID [BPRX2T]
5.cSample ID [BPRX2V]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899045
Page 13 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BP9DB6]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899046
Page 14 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/10/2020 16:44
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899047
Page 15 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899048
Page 16 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899049
Page 17 of 163
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899050
Page 18 of 163
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and
Address (Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899051
Page 19 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BP9DJL]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899052
Page 20 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay
of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/1/2020 15:06
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899053
Page 21 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/30/2020
2.Erroneous Visit
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899054
Page 22 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/30/2020
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 [BRDC39]
5.bSample ID [BSHLL2]
5.cSample ID [BSHLL3]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899055
Page 23 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899056
Page 24 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899057
Page 25 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899058
Page 26 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899059
Page 27 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899060
Page 28 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899061
Page 29 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899062
Page 30 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899063
Page 31 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899064
Page 32 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899065
Page 33 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899066
Page 34 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899067
Page 35 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899068
Page 36 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899069
Page 37 of 163
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899070
Page 38 of 163
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899071
Page 39 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899072
Page 40 of 163
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899073
Page 41 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899074
Page 42 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899075
Page 43 of 163
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Iden
tifierAdverse
EventStart DateIs the Adverse Event St
ill OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Stroke (C
VA) Nov/2/2020 UN
K:UNK NO
End Date Time:
Dec/15/2020 UNK:U
NK
 Repeating
Pages
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899076
Page 44 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Stroke (CVA)]
4.Start Date Time: Nov/2/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/15/2020 UNK:UNK
6.Toxicity Grade: 3
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899077
Page 45 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical intervention
to prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[not related to drug or non-drug treatment]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899078
Page 46 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[2020437779]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899079
Page 47 of 163
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication Er
rors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899080
Page 48 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899081
Page 49 of 163
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899082
Page 50 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899083
Page 51 of 163
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899084
Page 52 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899085
Page 53 of 163
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryTreatment Iden
tifierCon Non-Drug Treatments Pr
e-specifiedTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899086
Page 54 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899087
Page 55 of 163
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899088
Page 56 of 163
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899089
Page 57 of 163
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899090
Page 58 of 163
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899091
Page 59 of 163
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899092
Page 60 of 163
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899093
Page 61 of 163
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899094
Page 62 of 163
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899095
Page 63 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899096
Page 64 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899097
Page 65 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899098
Page 66 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899099
Page 67 of 163
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899100
Page 68 of 163
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response -
Is participant willing to return
for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899101
Page 69 of 163
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899102
Page 70 of 163
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899103
Page 71 of 163
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899104
Page 72 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/30/2020
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899105
Page 73 of 163
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899106
Page 74 of 163
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
John Rubino  Approved Mar-12-2021 17:32:37 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnRubino, 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.
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899107
Page 75 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-10-2020 16:50:48 (UTC-05:00)
Eastern Time (US & Canada)N/A
Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899108
Page 76 of 163
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-10-2020 16:57:45 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899109
Page 77 of 163
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-10-2020 16:57:45 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899110
Page 78 of 163
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-10-2020 16:57:45 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899111
Page 79 of 163
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-10-2020 16:57:45 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899112
Page 80 of 163
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-10-2020 16:57:45 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899113
Page 81 of 163
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-10-2020 16:57:45 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899114
Page 82 of 163
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-10-2020 16:57:45 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899115
Page 83 of 163
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-10-2020 16:57:45 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899116
Page 84 of 163
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-10-2020 16:57:45 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899117
Page 85 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-01-2020 15:18:50 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899118
Page 86 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-01-2020 15:18:50 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899119
Page 87 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-01-2020 15:18:50 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899120
Page 88 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-01-2020 15:18:50 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899121
Page 89 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-01-2020 15:18:50 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899122
Page 90 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-01-2020 15:18:50 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899123
Page 91 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-01-2020 15:18:50 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899124
Page 92 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-01-2020 15:18:50 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899125
Page 93 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-01-2020 15:18:50 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899126
Page 94 of 163
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
John Rubino  Approved Mar-12-2021 17:32:37 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnRubino, 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 Mar-02-2021 12:05:16 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John Rubino  Approved Jan-21-2021 17:18:39 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899127
Page 95 of 163
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, JohnRubino, 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 Jan-19-2021 12:20:18 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John Rubino  Approved Nov-09-2020 19:15:27 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnRubino, 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-06-2020 14:10:14 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899128
Page 96 of 163
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
John Rubino  Approved Nov-05-2020 19:46:29 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnRubino, 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.
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899129
Page 97 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-10-2020
16:49:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-10-2020
16:49:52
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899130
Page 98 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-10-2020
16:50:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent
Obtained
Sep/10/2020Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899131
Page 99 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-10-2020
16:49:24
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10211190Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-10-2020
16:49:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1954Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-10-2020
16:50:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-10-2020
16:50:19
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LA
TINO(A) OR OF SPANIInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899132
Page 100 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US &
Canada)SH ORIGIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-10-2020
16:50:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899133
Page 101 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020
16:50:39
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899134
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***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-10-2020
16:54:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-10-2020
16:54:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-10-2020
16:54:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899135
Page 103 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-10-2020
16:56:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term
:Seasonal All
ergic Rhiniti
s
Start Date: UNK/UNK/
1979
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-10-2020
16:56:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
16:56:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Seasonal Allergic Rhiniti
sInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899136
Page 104 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.a Start Date:
Date Location User Value Reason
Sep-10-2020
16:56:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1979Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-10-2020
16:56:00
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-10-2020
16:56:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History T
erm:Gastroesopha
geal Reflux D
isease
Start Dat
e:UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899137
Page 105 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-10-2020
16:56:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
16:56:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Gastroesophageal Reflux
DiseaseInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-10-2020
16:56:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-10-2020
16:56:20
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899138
Page 106 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada)
1.c
Date Location User Value Reason
Sep-10-2020
16:56:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Post Men
opausal
Start Date: UNK/UN
K/2000
Ongoing: YESInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899139
Page 107 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Sep-10-2020
16:56:34
(UTC-05:00)
Eastern 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
Sep-10-2020
16:56:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Post MenopausalInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-10-2020
16:56:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-10-2020
16:56:34
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899140
Page 108 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada)
1.d
Date Location User Value Reason
Sep-10-2020
16:56:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Tonsillitis
Start Date: UNK/UNK/
1959
Ongoing: NO
End Date:
UNK/U
NK/195
9Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899141
Page 109 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Sep-10-2020
16:56:51
(UTC-05:00)
Eastern 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
Sep-10-2020
16:56:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
TonsillitisInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-10-2020
16:56:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1959Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-10-2020
16:56:51
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899142
Page 110 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada) UNK/UNK/1959
1.e
Date Location User Value Reason
Sep-10-2020
16:57:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:Tonsillecto
my
Start Date: UNK/UNK/
1959
Ongoing: NO
End Date:
UNK/U
NK/195
9Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899143
Page 111 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-10-2020
16:57:07
(UTC-05:00)
Eastern 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
Sep-10-2020
16:57:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
TonsillectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-10-2020
16:57:07
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1959Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-10-2020
16:57:07
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899144
Page 112 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada) UNK/UNK/1959
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899145
Page 113 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020
16:57:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-10-2020
16:57:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
67.7Initial Entry
3. Unit:
Date Location User Value Reason
Sep-10-2020
16:57:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-10-2020
16:57:34ACV0PFEINFP6000  Data Entry:
154.0Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899146
Page 114 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US &
Canada)
5. Unit:
Date Location User Value Reason
Sep-10-2020
16:57:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-10-2020
16:57:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.5Initial Entry
7.a
Date Location User Value Reason
Sep-10-2020
16:57:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Record Identi
fier::1
Temperature: 97.6
Temperature
Unit:F
Temperature
Location::FOREH
EADInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899147
Page 115 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Record Identifier:
Date Location User Value Reason
Sep-10-2020
16:57:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-10-2020
16:57:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-10-2020
16:57:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-10-2020
16:57:34
(UTC-05:00)
Eastern Time (US &ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899148
Page 116 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada)
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899149
Page 117 of 163
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-10-2020
16:57:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-10-2020
16:57:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-10-2020
16:57:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-10-2020
16:57:45ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899150
Page 118 of 163
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US &
Canada)
5. Specimen Type:
Date Location User Value Reason
Sep-10-2020
16:57:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-10-2020
16:57:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defin
ed Identifier:Not Ap
plicable
Test:: Not Ap
plicable
Result:: Not Ap
plicable
Not Done:: Not Ap
plicableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-10-2020
16:57:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899151
Page 119 of 163
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Test:
Date Location User Value Reason
Sep-10-2020
16:57:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-10-2020
16:57:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-10-2020
16:57:45
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899152
Page 120 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-10-2020
17:03:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-10-2020
17:03:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
257393Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899153
Page 121 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020
18:09:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020
18:09:31
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020
18:09:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020
18:09:19ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899154
Page 122 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)Sample ID: BP9D5R
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
18:09:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP9D5RInitial Entry
5.b
Date Location User Value Reason
Sep-10-2020
18:09:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRX2TInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-10-2020
18:09:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPRX2TInitial Entry
5.c
Date Location User Value Reason
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899155
Page 123 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-10-2020
18:09:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRX2VInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-10-2020
18:09:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPRX2VInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899156
Page 124 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020
18:33:24
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020
18:33:24
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020
18:33:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020
18:09:58ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899157
Page 125 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)Sample ID: BP9DB6
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
18:09:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP9DB6Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899158
Page 126 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020
17:04:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020
17:04:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020
17:04:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020
17:04:58
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 16:44Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899159
Page 127 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US &
Canada)
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020
17:04:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020
17:04:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-10-2020
17:04:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020
17:04:58ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899160
Page 128 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US &
Canada)FIED OBSERVATION PE
RIOD
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-10-2020
17:04:58
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899161
Page 129 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-10-2020
17:04:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICI
TY E-DIARY NOT COL
LECTED FOR THIS SU
BJECTInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899162
Page 130 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-01-2020
15:18:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899163
Page 131 of 163
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-01-2020
15:18:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2.a
Date Location User Value Reason
Oct-01-2020
15:18:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Identi
fier::1
Temperature: 97.6
Temperature
Unit:F
Temperature
Location::FOREH
EADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-01-2020
15:18:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899164
Page 132 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-01-2020
15:18:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-01-2020
15:18:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-01-2020
15:18:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899165
Page 133 of 163
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-01-2020
15:18:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-01-2020
15:18:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-01-2020
15:18:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-01-2020
15:18:50ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899166
Page 134 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
5. Specimen Type:
Date Location User Value Reason
Oct-01-2020
15:18:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-01-2020
15:18:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defi
ned Identifier
:Not Ap
plicable
Test:: Not Ap
plicable
Result:: Not Ap
plicable
Not Done:: Not Ap
plicableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-01-2020
15:18:50
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899167
Page 135 of 163
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
6.a Test:
Date Location User Value Reason
Oct-01-2020
15:18:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-01-2020
15:18:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-01-2020
15:18:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899168
Page 136 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020
15:19:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020
15:19:12
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020
15:19:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-01-2020
15:19:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899169
Page 137 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
correct as
appropriate.
Oct-01-2020
15:19:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020
15:19:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9DJLInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020
15:19:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP9DJLInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899170
Page 138 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-01-2020
15:19:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020
15:19:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-01-2020
15:19:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-01-2020
15:19:37
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 15:06Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899171
Page 139 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020
15:19:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-01-2020
15:19:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-01-2020
15:19:37
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-01-2020
15:19:37ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899172
Page 140 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US &
Canada)FIED OBSERVATION PE
RIOD
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Oct-01-2020
15:19:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899173
Page 141 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-30-2020
14:18:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899174
Page 142 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020
14:18:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020
14:18:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020
15:39:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-30-2020
14:18:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
entered. Please
review and
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899175
Page 143 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
correct as
appropriate.
Oct-30-2020
14:18:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020
15:39:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRDC3
9Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020
15:39:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRDC39Initial Entry
5.b
Date Location User Value Reason
Oct-30-2020
15:39:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSHLL2Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899176
Page 144 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.b Sample ID
Date Location User Value Reason
Oct-30-2020
15:39:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSHLL2Initial Entry
5.c
Date Location User Value Reason
Oct-30-2020
15:39:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSHLL3Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-30-2020
15:39:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSHLL3Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899177
Page 145 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-30-2020
14:20:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-30-2020
14:20:39
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-30-2020
14:20:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899178
Page 146 of 163
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899179
Page 147 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Stroke (CVA)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-06-2020
14:10:14ACV0PFEINFP6000  Data Entry:
Nov/2/2020 UNK:UNInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899180
Page 148 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)K
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021
07:20:07
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Closed Response
satisfies query
Mar-02-2021
12:05:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto
Query
Mar-02-2021
12:05:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/15/2020 UN
K:UNKTranscription
Error
Mar-02-2021
12:05:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For Stroke
(CVA) End
Date 15/Dec
/2021, is a
future date
relative to when
it was entered
on 02/Mar
/2021. Please
correct.
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0899181
Page 149 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-02-2021
12:05:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription
Error
Mar-02-2021
12:05:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/15/2021 UN
K:UNKTranscription
Error
Mar-01-2021
14:15:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Juleen Gayed Query 1: Opened Clin: Please
confirm if this
AE is still
ongoing and
whether the
participant
remains
hospitalised.
Please provide
an SAE update
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
3Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0899182
Page 150 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical
event (i.e. may jeopardize subject and may require medical/surgical intervention to prevent above
outcomes).
Date Location User Value Reason
Nov-11-2020
22:03:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed Query closed;
will follow for
SAE update with
the requested
COVID test info
Nov-11-2020
09:01:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered Please note that
without further
medical records,
COVID test
status is
unknown.
Updated SAE
report will be
sent today,
11/11/2020.
Nov-10-2020
23:50:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Reissued:
OpenedClinical Thank
you for your
reply. The
relevant tests
statement reads
as referring to
CVA tests.
Please specify
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899183
Page 151 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
that without
further medical
records, COVID
test status is
unknown
Nov-10-2020
15:23:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered Relevant tests is
marked
"unknown" in
the SAE report
indicating it is
not known if a
COVID test was
performed while
in the hospital.
Please clarify
where else this
needs to be
documented in
the SAE report.
Nov-10-2020
12:23:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opened Clinical COVID
test status
(yes/no) during
Hospitalization
has not been
reported in the
SAE. Please
submit a
follow-up SAE
form
[#2020437779]
to document if
COVID testing
was performed
(YES/NO/info
not available)
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899184
Page 152 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
and if yes,
date/result.
Nov-07-2020
09:40:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Stroke
(CVA):
Response to "Is
the adverse
event serious?"
is 'Yes' but
"Serious
Adverse Event
Number" is
blank.
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious even
t associated with c
ongenital anomaly
or birth defect?
NO
Did this serious ev
ent result in death?
NO
Did this serious ev
ent require or prol
ong hospitalization
?Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899185
Page 153 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
YES
Did this serious ev
ent result in persist
ent or significant d
isability/incapacity
?
NO
Is this serious even
t life threatening?
NO
Other medically i
mportant serious e
vent
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-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899186
Page 154 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-11-2020
05:40:38
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-10-2020
13:00:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered SAE is not a
result of any
treatment
errors (drug or
non-drug).
None of these
responses are
applicable.
Nov-09-2020
20:13:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: AE
of stroke is
considered not
related to
vaccine but
'Other: not
related to drug
or non-drug
treatment'.
Please clarify
response.
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), this
event is due to:
OTHER
If Other, specify:
not related to drInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899187
Page 155 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ug or non-drug
treatment
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User ValueReason
Mar-04-2021 ACV0PFEINFP6000  QueryResponse satisfies query
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899188
Page 156 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
01:33:49
(UTC-05:00)
Eastern Time
(US &
Canada)2: Clo
sed
Mar-03-2021
14:32:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dCRF states outcome is
recovered/resolved
Mar-03-2021
05:33:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Op
enedSAE
RECON:AER#2020437779,outcome
was reported as
RECOVERED/RESOLVED to
Safety DB however, recorded as
Recovering/Resolving on AE CRF.
Please confirm correct outcome. If
safety update is required, please
submit a follow-up form.
Mar-02-2021
12:06:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Clo
sedClose Auto Query
Mar-02-2021
12:06:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
REC
OVE
RED/
RESO
LVEDNew Information
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899189
Page 157 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-02-2021
12:05:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Op
enedFor AE Stroke (CVA): Response to
"What was the outcome of this
adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
REC
OVE
RING
/RES
OLVI
NGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-06-2020
14:10:14
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-07-2020
09:40:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
2020437779Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899190
Page 158 of 163
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021
12:20:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899191
Page 159 of 163
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-19-2021
12:21:54
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-19-2021
12:20:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing in
the DISP visit.
Please complete
this date.
Jan-19-2021
12:20:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to
return for Vaccination 3
Participant is:
eligible and NOT co
nfirmed to have rece
ived only placebo at
Vaccination 1/2Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899192
Page 160 of 163
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-19-2021
12:21:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021
12:21:54
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY
FOR ADDITIONAL VA
CCINATIONInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899193
Page 161 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-30-2020
14:20:39
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-10-2020
17:03:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMI
ZEDInitial Entry
Sep-10-2020
16:54:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-30-2020
14:20:39
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/30/2020Initial Entry
Sep-10-2020
17:03:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899194
Page 162 of 163
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-10-2020
16:54:10
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899195
Page 163 of 163
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211190 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-05-2020
16:06:22
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d18\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899196