125742 S1 M5 CRF c4591001 1021 10211181

Document text

Page 1 of 235
***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: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898799
Page 2 of 235
***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: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898800
Page 3 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10211181]
2.Birth Date: 1952
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:
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898801
Page 4 of 235
***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: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898802
Page 5 of 235
***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: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898803
Page 6 of 235
***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: 10211181 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: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898804
Page 7 of 235
***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: 10211181 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:[Hypertension]
Start Date: UNK/UNK/2004
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypothyroidism]
Start Date: UNK/UNK/2004
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Plummer Disease]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2004
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898805
Page 8 of 235
***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: 10211181 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:[Total Thyroidectomy]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Tonsillectomy]
Start Date: UNK/UNK/1959
Ongoing: NO
End Date:
UNK/UNK/1959
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898806
Page 9 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Allergy to Cipro]
Start Date: UNK/UNK/2005
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Allergy to Penicillin]
Start Date: UNK/UNK/1956
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Allergy to Morphine]
Start Date: UNK/UNK/1959
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Post Menopausal]
Start Date: UNK/UNK/1999
Ongoing: YES
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898807
Page 10 of 235
***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: 10211181 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: [83.2]
3.Unit: kg
4.Height: [163.0]
5.Unit: cm
6.Body Mass Index: [31.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898808
Page 11 of 235
***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: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898809
Page 12 of 235
***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: 10211181 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: [256149]
3.Randomization Group: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898810
Page 13 of 235
***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: 10211181 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 [BP9D5F]
5.bSample ID [BPRX26]
5.cSample ID [BPRX27]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898811
Page 14 of 235
***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: 10211181 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 [BP9D9X]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898812
Page 15 of 235
***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: 10211181 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 09:37
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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898813
Page 16 of 235
***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: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898814
Page 17 of 235
***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: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898815
Page 18 of 235
***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: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898816
Page 19 of 235
***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: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898817
Page 20 of 235
***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: 10211181 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 [BP9DJC]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898818
Page 21 of 235
***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: 10211181 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 09:45
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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898819
Page 22 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898820
Page 23 of 235
***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: 10211181 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/29/2020
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 [BRDC2V]
5.bSample ID [BSHLK4]
5.cSample ID [BSHLK5]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898821
Page 24 of 235
***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: 10211181 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:
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898822
Page 25 of 235
***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: 10211181 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: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898823
Page 26 of 235
***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: 10211181 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 [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898824
Page 27 of 235
***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: 10211181 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 [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898825
Page 28 of 235
***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: 10211181 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?
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898826
Page 29 of 235
***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: 10211181 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:
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898827
Page 30 of 235
***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: 10211181 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:
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898828
Page 31 of 235
***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: 10211181 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 [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898829
Page 32 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898830
Page 33 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898831
Page 34 of 235
***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: 10211181 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/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898832
Page 35 of 235
***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: 10211181 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: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898833
Page 36 of 235
***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: 10211181 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:
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898834
Page 37 of 235
***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: 10211181 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 [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898835
Page 38 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Breast Cancer (
right breast) Feb/11/2021
UNK:UNK YES  Repeating
Pages
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898836
Page 39 of 235
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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)[Breast Cancer (right breast)]
4.Start Date Time: Feb/11/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898837
Page 40 of 235
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
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:
[unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898838
Page 41 of 235
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:NOT RECOVERED/NOT 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[2021270613]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898839
Page 42 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1. [ ]       Repeating
Pages
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898840
Page 43 of 235
***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: 10211181 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[ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898841
Page 44 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned Identifie
rCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of Med
icationStart
DateForm Instan
ce
 1.1  VACCINATI
ONS NO  Seasonal Influ
enza Vaccine Oct/16
/2020 Repeating
Pages
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898842
Page 45 of 235
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Seasonal Influenza Vaccine]
5.Date: Oct/16/2020
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898843
Page 46 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898844
Page 47 of 235
***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: 10211181 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?
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898845
Page 48 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898846
Page 49 of 235
***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: 10211181 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?
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898847
Page 50 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898848
Page 51 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898849
Page 52 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898850
Page 53 of 235
***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: 10211181 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:
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898851
Page 54 of 235
***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: 10211181 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:
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898852
Page 55 of 235
***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: 10211181 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?
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898853
Page 56 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898854
Page 57 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898855
Page 58 of 235
***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: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898856
Page 59 of 235
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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 per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898857
Page 60 of 235
***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: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898858
Page 61 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898859
Page 62 of 235
***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: 10211181 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: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898860
Page 63 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898861
Page 64 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/22/2021
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898862
Page 65 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898863
Page 66 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/22/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898864
Page 67 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898865
Page 68 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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:
Jan/22/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRDC7J]
5.bSample ID [BRTTWJ]
5.cSample ID [BRTTWK]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898866
Page 69 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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:
Jan/22/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN1ZT5]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898867
Page 70 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/22/2021 08:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898868
Page 71 of 235
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/10/2021
2.Erroneous Visit
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898869
Page 72 of 235
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898870
Page 73 of 235
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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:
Feb/10/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR1706]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898871
Page 74 of 235
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/10/2021 08:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898872
Page 75 of 235
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898873
Page 76 of 235
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/10/2021
3.Comments: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898874
Page 77 of 235
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898875
Page 78 of 235
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898876
Page 79 of 235
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898877
Page 80 of 235
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898878
Page 81 of 235
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Mar/10/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898879
Page 82 of 235
***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: 10211181 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/29/2020
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898880
Page 83 of 235
***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: 10211181 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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898881
Page 84 of 235
***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: 10211181 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 17:26:42 (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.
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898882
Page 85 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-10-2020 09:07:53 (UTC-05:00)
Eastern Time (US & Canada)N/A
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898883
Page 86 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-10-2020 09:11:36 (UTC-05:00)
Eastern Time (US & Canada)N/A
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898884
Page 87 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-10-2020 09:11:36 (UTC-05:00)
Eastern Time (US & Canada)N/A
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898885
Page 88 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-10-2020 09:11:36 (UTC-05:00)
Eastern Time (US & Canada)N/A
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898886
Page 89 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-10-2020 09:11:36 (UTC-05:00)
Eastern Time (US & Canada)N/A
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898887
Page 90 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-10-2020 09:11:36 (UTC-05:00)
Eastern Time (US & Canada)N/A
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898888
Page 91 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-10-2020 09:11:36 (UTC-05:00)
Eastern Time (US & Canada)N/A
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898889
Page 92 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-10-2020 09:11:36 (UTC-05:00)
Eastern Time (US & Canada)N/A
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898890
Page 93 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-10-2020 09:11:36 (UTC-05:00)
Eastern Time (US & Canada)N/A
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898891
Page 94 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-10-2020 09:11:36 (UTC-05:00)
Eastern Time (US & Canada)N/A
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898892
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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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-01-2020 10:00:08 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898893
Page 96 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-01-2020 10:00:08 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898894
Page 97 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-01-2020 10:00:08 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898895
Page 98 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-01-2020 10:00:08 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898896
Page 99 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-01-2020 10:00:08 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898897
Page 100 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-01-2020 10:00:08 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898898
Page 101 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-01-2020 10:00:08 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898899
Page 102 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-01-2020 10:00:08 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898900
Page 103 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aOct-01-2020 10:00:08 (UTC-05:00)
Eastern Time (US & Canada)non-WOCBP
Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898901
Page 104 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-22-2021 08:33:53 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898902
Page 105 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-22-2021 08:34:20 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898903
Page 106 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-22-2021 08:34:20 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898904
Page 107 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Jan-22-2021 08:34:20 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898905
Page 108 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Jan-22-2021 08:34:20 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898906
Page 109 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Jan-22-2021 08:34:20 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898907
Page 110 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Jan-22-2021 08:34:20 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898908
Page 111 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aJan-22-2021 08:34:20 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898909
Page 112 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aJan-22-2021 08:34:20 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898910
Page 113 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aJan-22-2021 08:34:20 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898911
Page 114 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-10-2021 11:29:13
(UTC-05:00) Eastern Time (US &
Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898912
Page 115 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-10-2021 11:29:13 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898913
Page 116 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Feb-10-2021 11:29:13 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898914
Page 117 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Feb-10-2021 11:29:13 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898915
Page 118 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Feb-10-2021 11:29:13 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898916
Page 119 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Feb-10-2021 11:29:13 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898917
Page 120 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aFeb-10-2021 11:29:13 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898918
Page 121 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aFeb-10-2021 11:29:13 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898919
Page 122 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aFeb-10-2021 11:29:13 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898920
Page 123 of 235
***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: 10211181 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 17:26:42 (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 Feb-10-2021 11:29:04 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John
Rubino Approved Jan-25-2021 19:15:35 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898921
Page 124 of 235
***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: 10211181 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-22-2021 08:33:04 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John
Rubino Approved Jan-21-2021 14:43:24 (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.
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898922
Page 125 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
 N/A Jan-19-2021 13:06:15 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John
Rubino Approved Nov-05-2020 19:40:36 (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.
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898923
Page 126 of 235
***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: 10211181 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
09:07:17
(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
09:07:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898924
Page 127 of 235
***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: 10211181 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
09:07:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consen
t Obtained
Sep/10/2020Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898925
Page 128 of 235
***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: 10211181 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
09:07:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10211181Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-10-2020
09:07:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1952Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-10-2020
09:07:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898926
Page 129 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-10-2020
09:07:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-10-2020
09:07:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898927
Page 130 of 235
***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: 10211181 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
09:07:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898928
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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: 10211181 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
09:08:04
(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
09:08:04
(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
09:08:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898929
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***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: 10211181 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
09:08:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Hyperte
nsion
Start Date: UNK/U
NK/200
4
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-10-2020
09:08:20
(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
09:08:20
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898930
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***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
1.a Start Date:
Date Location User Value Reason
Sep-10-2020
09:08:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-10-2020
09:08:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-10-2020
09:08:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Hypothy
roidism
Start Date: UNK/U
NK/200
4
Ongoing: YESInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898931
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***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: 10211181 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
09:08:31
(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
09:08:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HypothyroidismInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-10-2020
09:08:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-10-2020
09:08:31ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d17\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-2021-5683-0898932
Page 135 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
1.c
Date Location User Value Reason
Sep-10-2020
09:08:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:3
Medical H
istory Ter
m:Plummer
Disease
Start Date
:UNK/UN
K/2003
Ongoing: NO
End Date
:
UNK/U
NK/200
4Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898933
Page 136 of 235
***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: 10211181 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
09:08:45
(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
09:08:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Plummer DiseaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-10-2020
09:08:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2003Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-10-2020
09:08:45ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d17\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-2021-5683-0898934
Page 137 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2004
1.d
Date Location User Value Reason
Sep-10-2020
09:08:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:Tonsillitis
Start Date
:UNK/UN
K/1959
Ongoing: NO
End Date
:
UNK/U
NK/195
9Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898935
Page 138 of 235
***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: 10211181 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
09:08:57
(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
09:08:57
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
TonsillitisInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-10-2020
09:08:57
(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
09:08:57ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d17\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-2021-5683-0898936
Page 139 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/1959
1.e
Date Location User Value Reason
Sep-10-2020
09:09:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical H
istory Ter
m:Total Thyr
oidectomy
Start Date
:UNK/UN
K/2004
Ongoing: NO
End Date
:
UNK/U
NK/200
4Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898937
Page 140 of 235
***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: 10211181 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
09:09:11
(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
09:09:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Total ThyroidectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-10-2020
09:09:11
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-10-2020
09:09:11ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d17\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-2021-5683-0898938
Page 141 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/2004
1.f
Date Location User Value Reason
Sep-10-2020
09:09:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:6
Medical H
istory Ter
m:Tonsillecto
my
Start Date
:UNK/UN
K/1959
Ongoing: NO
End Date
:
UNK/U
NK/195
9Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898939
Page 142 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Sep-10-2020
09:09:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
09:09:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
TonsillectomyInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-10-2020
09:09:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1959Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-10-2020
09:09:23ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d17\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-2021-5683-0898940
Page 143 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)End Date:
UNK/UNK/1959
1.g
Date Location User Value Reason
Sep-10-2020
09:09:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical His
tory Term:Allergy t
o Cipro
Start Date: UNK/U
NK/200
5
Ongoing: YESInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898941
Page 144 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Sep-10-2020
09:09:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
09:09:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Allergy to CiproInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-10-2020
09:09:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-10-2020
09:09:37ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d17\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-2021-5683-0898942
Page 145 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
1.h
Date Location User Value Reason
Sep-10-2020
09:09:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:8
Medical Hi
story Term
:Allergy t
o Penicill
in
Start Date: UNK/UN
K/1956
Ongoing: YESInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898943
Page 146 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Sep-10-2020
09:09:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
09:09:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Allergy to PenicillinInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-10-2020
09:09:49
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1956Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-10-2020
09:09:49ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d17\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-2021-5683-0898944
Page 147 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
1.i
Date Location User Value Reason
Sep-10-2020
09:10:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical Hi
story Term
:Allergy to
Morphine
Start Date: UNK/UN
K/1959
Ongoing: YESInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898945
Page 148 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Sep-10-2020
09:10:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
09:10:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Allergy to MorphineInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-10-2020
09:10:01
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1959Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-10-2020
09:10:01ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d17\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-2021-5683-0898946
Page 149 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
1.j
Date Location User Value Reason
Sep-10-2020
10:13:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:10
Medical His
tory Term:Post Me
nopausal
Start Date: UNK/U
NK/1999
Ongoing: YESInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898947
Page 150 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Sep-10-2020
10:13:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
10:13:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Post MenopausalInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-10-2020
10:13:44
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1999Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-10-2020
10:13:44ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d17\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-2021-5683-0898948
Page 151 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898949
Page 152 of 235
***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: 10211181 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
09:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-10-2020
09:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
83.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-10-2020
09:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d17\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-2021-5683-0898950
Page 153 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-10-2020
09:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
163.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-10-2020
09:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-10-2020
09:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.3Initial Entry
7.a
Date Location User Value Reason
Sep-10-2020
09:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperatur
e:98.2Initial Entry
090177e196ae3d17\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-2021-5683-0898951
Page 154 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Sep-10-2020
09:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-10-2020
09:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-10-2020
09:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3d17\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-2021-5683-0898952
Page 155 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Temperature Location:
Date Location User Value Reason
Sep-10-2020
09:11:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898953
Page 156 of 235
***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: 10211181 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
09:11:36
(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
09:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-10-2020
09:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d17\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-2021-5683-0898954
Page 157 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-10-2020
09:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-10-2020
09:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-10-2020
09:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Def
ined Identifi
er:Not Ap
plicabl
e
Test:: Not Ap
plicabl
e
Result:: Not Ap
plicabl
e
Not Done:: Not Ap
plicabl
eInitial Entry
090177e196ae3d17\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-2021-5683-0898955
Page 158 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Sponsor ID:
Date Location User Value Reason
Sep-10-2020
09:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-10-2020
09:11:36
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-10-2020
09:11:36
(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
09:11:36ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d17\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-2021-5683-0898956
Page 159 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898957
Page 160 of 235
***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: 10211181 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
10:48:37
(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
10:48:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
256149Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898958
Page 161 of 235
***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: 10211181 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
09:57:44
(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
09:57:44
(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
09:58:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-10-2020
09:57:44
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898959
Page 162 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-10-2020
09:57:44
(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
09:58:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9D5FInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
09:58:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP9D5FInitial Entry
5.b
Date Location User Value Reason
090177e196ae3d17\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-2021-5683-0898960
Page 163 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-10-2020
09:58:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRX26Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-10-2020
09:58:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPRX26Initial Entry
5.c
Date Location User Value Reason
Sep-10-2020
09:58:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRX27Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-10-2020
09:58:23
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BPRX27Initial Entry
090177e196ae3d17\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-2021-5683-0898961
Page 164 of 235
***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: 10211181 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
09:58:57
(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
09:58:57
(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
09:59:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-10-2020
09:58:57
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898962
Page 165 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-10-2020
09:58:57
(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
09:59:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP9D9
XInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-10-2020
09:59:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP9D9XInitial Entry
090177e196ae3d17\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-2021-5683-0898963
Page 166 of 235
***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: 10211181 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
10:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020
10:49:56
(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
10:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898964
Page 167 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-10-2020
10:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 09:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020
10:49:56
(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
10:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-10-2020
10:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898965
Page 168 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020
10:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-10-2020
10:49:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898966
Page 169 of 235
***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: 10211181 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
09:11:51
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898967
Page 170 of 235
***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: 10211181 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
09:59:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898968
Page 171 of 235
***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: 10211181 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
09:59:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2.a
Date Location User Value Reason
Oct-01-2020
09:59:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Iden
tifier::1
Temperatur
e:97.6
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-01-2020
09:59:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3d17\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-2021-5683-0898969
Page 172 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Temperature:
Date Location User Value Reason
Oct-01-2020
09:59:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-01-2020
09:59:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-01-2020
09:59:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3d17\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-2021-5683-0898970
Page 173 of 235
***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: 10211181 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
10:00:08
(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
10:00:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-01-2020
10:00:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d17\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-2021-5683-0898971
Page 174 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-01-2020
10:00:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-01-2020
10:00:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-01-2020
10:00:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Def
ined Identifi
er:Not Ap
plicabl
e
Test:: Not Ap
plicabl
e
Result:: Not Ap
plicabl
e
Not Done:: Not Ap
plicabl
eInitial Entry
090177e196ae3d17\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-2021-5683-0898972
Page 175 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Sponsor ID:
Date Location User Value Reason
Oct-01-2020
10:00:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-01-2020
10:00:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-01-2020
10:00:08
(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
10:00:08ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d17\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-2021-5683-0898973
Page 176 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898974
Page 177 of 235
***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: 10211181 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
10:02:49
(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
10:02:49
(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
10:03:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-01-2020
10:02:49
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898975
Page 178 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-01-2020
10:02:49
(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
10:03:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9DJCInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020
10:03:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP9DJCInitial Entry
090177e196ae3d17\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-2021-5683-0898976
Page 179 of 235
***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: 10211181 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
10:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020
10:00:25
(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
10:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898977
Page 180 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-01-2020
10:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 09:45Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020
10:00:25
(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
10:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-01-2020
10:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898978
Page 181 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-01-2020
10:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-01-2020
10:00:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898979
Page 182 of 235
***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: 10211181 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-29-2020
08:30:35
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898980
Page 183 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020
08:30:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020
08:30:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020
10:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-29-2020
08:30:42
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898981
Page 184 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-29-2020
08:30:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
Oct-29-2020
10:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRDC2
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-29-2020
10:42:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRDC2VInitial Entry
5.b
Date Location User Value Reason
090177e196ae3d17\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-2021-5683-0898982
Page 185 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-29-2020
10:42:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BSHLK
4Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-29-2020
10:42:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSHLK4Initial Entry
5.c
Date Location User Value Reason
Oct-29-2020
10:43:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BSHLK
5Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-29-2020
10:43:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BSHLK5Initial Entry
090177e196ae3d17\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-2021-5683-0898983
Page 186 of 235
***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: 10211181 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-29-2020
08:30:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-29-2020
08:30:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-29-2020
08:30:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898984
Page 187 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898985
Page 188 of 235
***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, Not Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021
07:41:41
(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
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Breast Cancer (right b
reast)Initial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898986
Page 189 of 235
***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, Not Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/11/2021 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae3d17\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-2021-5683-0898987
Page 190 of 235
***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, Not Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-12-2021
09:21:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Breast
Cancer (right
breast):
Response to
"Is the
adverse event
serious?" is
'Yes' but
"Serious
Adverse
Event
Number" is
blank.
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event
associated with con
genital anomaly or b
irth defect?
NO
Did this serious eve
nt result in death?
NOInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898988
Page 191 of 235
***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, Not Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Did this serious eve
nt require or prolong
hospitalization?
NO
Did this serious eve
nt result in persisten
t or significant disab
ility/incapacity?
NO
Is this serious event
life threatening?
NO
Other medically imp
ortant serious event
YES
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
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898989
Page 192 of 235
***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, Not Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-11-2021
07:41:41
(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:
unknownInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d17\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-2021-5683-0898990
Page 193 of 235
***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, Not Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021
07:41:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/
NOT RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021
07:41:41
(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
Mar-12-2021
09:21:10ACV0PFEINFP6000  Data Entry:
2021270613Initial Entry
090177e196ae3d17\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-2021-5683-0898991
Page 194 of 235
***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, Not Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898992
Page 195 of 235
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-29-2020
08:31:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898993
Page 196 of 235
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - 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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Oct-29-2020
08:31:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Oct-29-2020
08:31:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Oct-29-2020
08:31:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NOInitial Entry
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
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898994
Page 197 of 235
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - 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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Oct-29-2020
08:31:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Seasonal Influenza Va
ccineInitial Entry
5. Date:
Date Location User Value Reason
Oct-29-2020
08:31:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898995
Page 198 of 235
***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: 10211181 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
13:06:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898996
Page 199 of 235
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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
13:06:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-19-2021
13:06:25
(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
13:06:25
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willin
g to return for Vacci
nation 3
Participant is:
eligible per local
/national recom
mendations and
confirmed to haInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898997
Page 200 of 235
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ve received only
placebo at Vacci
nation 1/2
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898998
Page 201 of 235
***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: 10211181 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
13:06:33
(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
13:06:33
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898999
Page 202 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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-22-2021
08:33:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899000
Page 203 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-22-2021
08:33:19
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Jan/22/2021Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899001
Page 204 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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
Jan-22-2021
08:34:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-22-2021
08:34:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING
1Initial Entry
3. Status:
Date Location User Value Reason
Jan-22-2021
08:34:12
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899002
Page 205 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-22-2021
08:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-22-2021
08:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-22-2021
08:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d17\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-2021-5683-0899003
Page 206 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-22-2021
08:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-22-2021
08:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Jan-22-2021
08:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-De
fined Identi
fier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
090177e196ae3d17\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-2021-5683-0899004
Page 207 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Sponsor ID:
Date Location User Value Reason
Jan-22-2021
08:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Jan-22-2021
08:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-22-2021
08:34:20
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-22-2021
08:34:20ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d17\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-2021-5683-0899005
Page 208 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899006
Page 209 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-22-2021
08:34:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-22-2021
08:34:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021
08:41:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-22-2021
08:34:41
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899007
Page 210 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-22-2021
08:34:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Jan/22/2021Initial Entry
5.a
Date Location User Value Reason
Jan-22-2021
08:41:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRDC7JInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-22-2021
08:41:43
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRDC7JInitial Entry
5.b
090177e196ae3d17\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-2021-5683-0899008
Page 211 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Jan-22-2021
08:41:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRTTW
JInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-22-2021
08:41:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRTTWJInitial Entry
5.c
Date Location User Value Reason
Jan-22-2021
08:42:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRTTW
KInitial Entry
090177e196ae3d17\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-2021-5683-0899009
Page 212 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Jan-22-2021
08:42:03
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRTTWKInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0899010
Page 213 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-22-2021
08:35:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-22-2021
08:35:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-22-2021
08:42:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-22-2021
08:35:42
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899011
Page 214 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Jan-22-2021
08:35:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Jan/22/2021Initial Entry
5.a
Date Location User Value Reason
Jan-22-2021
08:42:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN1ZT5Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-22-2021
08:42:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BN1ZT5Initial Entry
090177e196ae3d17\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-2021-5683-0899012
Page 215 of 235
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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
Jan-22-2021
09:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-22-2021
09:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-22-2021
09:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899013
Page 216 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-22-2021
09:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021 08:49Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-22-2021
09:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-22-2021
09:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-22-2021
09:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899014
Page 217 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8. Actual Dose:
Date Location User Value Reason
Jan-22-2021
09:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-22-2021
09:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-22-2021
09:00:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Jan-22-2021
09:00:58ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899015
Page 218 of 235
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899016
Page 219 of 235
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-10-2021
11:29:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899017
Page 220 of 235
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-10-2021
11:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-10-2021
11:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-10-2021
11:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d17\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-2021-5683-0899018
Page 221 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-10-2021
11:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Feb-10-2021
11:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Feb-10-2021
11:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-D
efined Ide
ntifier:Not A
pplica
ble
Test:: Not A
pplica
ble
Result:: Not A
pplica
ble
Not Done:: Not A
pplica
bleInitial Entry
090177e196ae3d17\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-2021-5683-0899019
Page 222 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6.a Sponsor ID:
Date Location User Value Reason
Feb-10-2021
11:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Feb-10-2021
11:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Feb-10-2021
11:29:13
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Feb-10-2021
11:29:13ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d17\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-2021-5683-0899020
Page 223 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899021
Page 224 of 235
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-10-2021
11:29:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-10-2021
11:29:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-10-2021
11:29:56
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-10-2021
11:29:34
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899022
Page 225 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Eastern Time
(US & Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-10-2021
11:29:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Feb/10/2021Initial Entry
5.a
Date Location User Value Reason
Feb-10-2021
11:29:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BR170
6Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-10-2021
11:29:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR1706Initial Entry
090177e196ae3d17\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-2021-5683-0899023
Page 226 of 235
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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
Feb-10-2021
11:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-10-2021
11:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-10-2021
11:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899024
Page 227 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-10-2021
11:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/10/2021 08:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-10-2021
11:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-10-2021
11:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Feb-10-2021
11:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899025
Page 228 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8. Actual Dose:
Date Location User Value Reason
Feb-10-2021
11:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-10-2021
11:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-10-2021
11:30:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Feb-10-2021
11:30:37ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899026
Page 229 of 235
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899027
Page 230 of 235
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-10-2021
17:13:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/10/2021Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899028
Page 231 of 235
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-10-2021
17:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-10-2021
17:13:15
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Mar/10/2021Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899029
Page 232 of 235
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211181 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
Mar-10-2021
17:13:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/10/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-10-2021
17:13:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREAT
MENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-10-2021
17:13:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0899030
Page 233 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-29-2020
08:30:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-10-2020
10:48:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-10-2020
09:08:04
(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-29-2020
08:30:53
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/29/2020Initial Entry
Sep-10-2020
10:48:37ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899031
Page 234 of 235
***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: 10211181 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00)
Eastern Time (US
& Canada)
Sep-10-2020
09:08:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0899032
Page 235 of 235
***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: 10211181 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
16:03:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d17\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b  
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0899033