125742 S1 M5 CRF c4591001 1044 10441093

Document text

Page 1 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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.
.Select appropriate response -
Protocol version24 JUL 2020
.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)
  
(b) (4)
FDA-CBER-2021-5683-0909010
Page 2 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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/8/2020
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909011
Page 3 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10441093]
2.Birth Date: 1960
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6)  -   
(b) (4)
FDA-CBER-2021-5683-0909012
Page 4 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/8/2020
2.Erroneous Visit
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909013
Page 5 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
(b) (4)
FDA-CBER-2021-5683-0909014
Page 6 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/8/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0909015
Page 7 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Medical History Details
1.Line/MH Number: Not Applicable
[ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]
Start Date: Not Applicable
//
Ongoing: Not Applicable
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909016
Page 8 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/8/2020
2.Weight: [71.8]
3.Unit: kg
4.Height: [175.3]
5.Unit: cm
6.Body Mass Index: [23.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)     
(b) (4)
FDA-CBER-2021-5683-0909017
Page 9 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/8/2020
2.Randomization Number: [254333]
3.Randomization Group: [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0909018
Page 10 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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/8/2020
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 [BN5YMX]
5.bSample ID [BLB61B]
5.cSample ID [BLB60M]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
         
(b) (4)
FDA-CBER-2021-5683-0909019
Page 11 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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/8/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please ent r barcode for each aliquot.
.aSam le ID [BN66P7]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
 
r   
(b) (4)
FDA-CBER-2021-5683-0909020
Page 12 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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/8/2020 13:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)          
(b) (4)
FDA-CBER-2021-5683-0909021
Page 13 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)
 
(b) (4)
FDA-CBER-2021-5683-0909022
Page 14 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/28/2020
2.Erroneous Visit
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909023
Page 15 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909024
Page 16 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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/28/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please ent r barcode for each aliquot.
.aSam le ID [BN66WC]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
 
r   
(b) (4)
FDA-CBER-2021-5683-0909025
Page 17 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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/28/2020 15:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)          
(b) (4)
FDA-CBER-2021-5683-0909026
Page 18 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/26/2020
2.Erroneous Visit
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909027
Page 19 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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/26/2020
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 [BRVKWC]
5.bSample ID [BRVKVM]
5.cSample ID [BPW0D3]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
         
(b) (4)
FDA-CBER-2021-5683-0909028
Page 20 of 152
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909029
Page 21 of 152
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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 [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
1   
(b) (4)
FDA-CBER-2021-5683-0909030
Page 22 of 152
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909031
Page 23 of 152
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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 [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
1   
(b) (4)
FDA-CBER-2021-5683-0909032
Page 24 of 152
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909033
Page 25 of 152
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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 [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
1   
(b) (4)
FDA-CBER-2021-5683-0909034
Page 26 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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:
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909035
Page 27 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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
4Symptoms:
Was symptom present?
Sy ptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
  
(b) (4)
FDA-CBER-2021-5683-0909036
Page 28 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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 [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
   
(b) (4)
FDA-CBER-2021-5683-0909037
Page 29 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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 [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
   
(b) (4)
FDA-CBER-2021-5683-0909038
Page 30 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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?
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
 
 
 
(b) (4)
FDA-CBER-2021-5683-0909039
Page 31 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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:
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0909040
Page 32 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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:
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909041
Page 33 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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 [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
   
(b) (4)
FDA-CBER-2021-5683-0909042
Page 34 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909043
Page 35 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909044
Page 36 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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/26/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)
   
(b) (4)
FDA-CBER-2021-5683-0909045
Page 37 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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: [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
(b) (4)
FDA-CBER-2021-5683-0909046
Page 38 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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:
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909047
Page 39 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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 [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
   
(b) (4)
FDA-CBER-2021-5683-0909048
Page 40 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Iden i
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Hypokalemia  Oct/23/2020 UNK
:UNK NO
End Date Time:
Oct/24/2020 UNK:UN
K
 Repeating
Pages
 2ADVERSE E
VENT 2  Muscle Sprain (Rig
ht Leg) Sep/23/2020 UN
K:UNK YES  Repeating
Pages
 3.ADVERSE E
VENT 3  Heroin Overdose  Oct/23/2020 UNK
:UNK NO
End Date Time:
Oct/24/2020 UNK:UN
K
 Repeating
Pages
 4.ADVERSE E
VENT 4  Hypomagnesemia  Oct/23/2020 UNK
:UNK NO
End Date Time:
Oct/24/2020 UNK:UN
K
 Repeating
Pages
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) I     
  I  -
(b) (4)
FDA-CBER-2021-5683-0909049
Page 41 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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)[Hypokalemia]
4.Start Date Time: Oct/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/24/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[heroin overdose]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
  
  
(b) (4)
FDA-CBER-2021-5683-0909050
Page 42 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13What was the outcome of this
adverse event?:RECOVERED/RESOLVED
4Did the adverse event cause the
subject to be discontinued from the
study?NO
15Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  
(b) (4)
FDA-CBER-2021-5683-0909051
Page 43 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Muscle Sprain (Right Leg)]
4.Start Date Time: Sep/23/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unk]
0.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
    
 
(b) (4)
FDA-CBER-2021-5683-0909052
Page 44 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
11Was a Concomitant Medication
given?YES
12Was a Non-Drug Treatment given? NO
13What was the outcome of this
adverse event?:RECOVERING/RESOLVING
4Did the adverse event cause the
subject to be discontinued from the
study?NO
15Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
  
(b) (4)
FDA-CBER-2021-5683-0909053
Page 45 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Heroin Overdose]
4.Start Date Time: Oct/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/24/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
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?
YES
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
  
  
(b) (4)
FDA-CBER-2021-5683-0909054
Page 46 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[heroin overdose]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13What was the outcome of this
adverse event?:RECOVERED/RESOLVED
4Did the adverse event cause the
subject to be discontinued from the
study?NO
15Serious Adverse Event Number:
For Pfizer Use Only[2020415415]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
  
(b) (4)
FDA-CBER-2021-5683-0909055
Page 47 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Hypomagnesemia]
4.Start Date Time: Oct/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/24/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[heroin overdose]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
  
  
(b) (4)
FDA-CBER-2021-5683-0909056
Page 48 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13What was the outcome of this
adverse event?:RECOVERED/RESOLVED
4Did the adverse event cause the
subject to be discontinued from the
study?NO
15Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
  
(b) (4)
FDA-CBER-2021-5683-0909057
Page 49 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ y Medication ErrorStar
DatIs the medi atio
n error Still Ong
oingStudy Medica
tion Er rs A
cti nForm nsta
nc
 1.MEDICAT
ION ERR
OR SUBJECT DOSED WITH IP THAT HAD T
EMPERATURE EXCURSION (PRODUCT
STORAGE ERROR) Sep/8
/2020
 NO
End Date:
Sep/8/2020
 NO ACTION
TAKEN Repeating
Pages
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 11  
(b) (4)
FDA-CBER-2021-5683-0909058
Page 50 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Medication Error
1.Category: MEDICATION ERROR
2.Medication Error (Type of
Medication Error):[SUBJECT DOSED WITH IP THAT HAD TEMPERATURE EXCURSION
(PRODUCT STORAGE ERROR)]
3.Start Date: Sep/8/2020
4.Is the medication error still
ongoing?NO
End Date:
Sep/8/2020
5.Latest Action Taken with Study
Treatment:NO ACTION TAKEN
6.Was a Concomitant Medication
given?NO
7.Was a Non-Drug Treatment given? NO
8.Did the Medication Error cause the
subject to be discontinued from the
study?NO
9.Was this medication error
associated with any adverse
events?NO
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
   
  
(b) (4)
FDA-CBER-2021-5683-0909059
Page 51 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  1 ;  
(b) (4)
FDA-CBER-2021-5683-0909060
Page 52 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
(b) (4)
FDA-CBER-2021-5683-0909061
Page 53 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1          Repeating
Pages
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   I  
 ~ 
(b) (4)
FDA-CBER-2021-5683-0909062
Page 54 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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?
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
      
(b) (4)
FDA-CBER-2021-5683-0909063
Page 55 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
C tegor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedatmen
tStart D
eForm Instance
 1.          Repeating Pages
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
     
(b) (4)
FDA-CBER-2021-5683-0909064
Page 56 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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?
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)      
(b) (4)
FDA-CBER-2021-5683-0909065
Page 57 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
  .    Repeating Pages
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909066
Page 58 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909067
Page 59 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909068
Page 60 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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:
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909069
Page 61 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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?
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)        
 
(b) (4)
FDA-CBER-2021-5683-0909070
Page 62 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909071
Page 63 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909072
Page 64 of 152
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909073
Page 65 of 152
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909074
Page 66 of 152
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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 [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
   
(b) (4)
FDA-CBER-2021-5683-0909075
Page 67 of 152
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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 [ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
   
(b) (4)
FDA-CBER-2021-5683-0909076
Page 68 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909077
Page 69 of 152
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4)
FDA-CBER-2021-5683-0909078
Page 70 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/28/2021
2.Primary Reason for Unblinding: SUBJECT SAFETY CONCERN
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909079
Page 71 of 152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable Comments
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0909080
Page 72 of 152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4)
FDA-CBER-2021-5683-0909081
Page 73 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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/26/2020
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909082
Page 74 of 152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4)
FDA-CBER-2021-5683-0909083
Page 75 of 152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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
Aaron Hartman  Approved Mar-03-2021 13:24:01 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, 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.
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
 
    
(b) (4)
FDA-CBER-2021-5683-0909084
Page 76 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-08-2020 14:13:17 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)      
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909085
Page 77 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-08-2020 14:18:12 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)      
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909086
Page 78 of 152
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-08-2021 18:53:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)      
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909087
Page 79 of 152
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-08-2021 18:53:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909088
Page 80 of 152
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormFeb-08-2021 18:54:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)      
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909089
Page 81 of 152
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Feb-08-2021 18:54:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909090
Page 82 of 152
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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
Aaron Hartman  Approved Mar-03-2021 13:24:01 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, 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.
 A Feb-08-2021 18:52:56 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
ignature
nvalidate
Affidavit:
N/A
Aaron Hartman  Approved Nov-16-2020 16:17:42 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, 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.
 A Nov-16-2020 13:36:09 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
ignature
nvalidate
Affidavit:
N/A
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
     
  
     
  
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909091
Page 83 of 152
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aaron Hartman  Approved Nov-06-2020 17:09:22 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, AaronHartman, 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.
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)      
(b) (4)
FDA-CBER-2021-5683-0909092
Page 84 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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-08-2020 14:12:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020In tial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-08-2020 14:12:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
   
   
  
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909093
Page 85 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-08-2020 14:12:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Sep/8/2020Initial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909094
Page 86 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-27-2020
22:31:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed event reported in AE CRF
Oct-27-2020
08:45:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Oct-27-2020
07:01:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020415415
hypokalemia(onset
date:23Oct2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-08-2020
14:12:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10441093Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-08-2020 14:12:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  a to calc
( uto alc)Data Entry:
1960Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-08-2020 14:12:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEIn tial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (6) 
 
  
    
  
    
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909095
Page 87 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. Ethnicity:
Date Location User Value Reason
Sep-08-2020 14:12:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-08-2020 14:12:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  D a Entry:
W ITEInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
      
  1  
  
    
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909096
Page 88 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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-08-2020 14:13:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020In tial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
   
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909097
Page 89 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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-08-2020 14:13:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-08-2020 14:13:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-08-2020 14:13:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
   
 
  
  
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909098
Page 90 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 14:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020In tial Entry
2. Weight:
Date Location User Value Reason
Sep-08-2020 14:17:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-08-2020 14:17:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
71.8Transcription Error
Sep-08-2020 14:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Weight 175.3 is
outside of Normal
Range 25 - 136 for
kg or 50 - 300 for
lb.
ep-08-2020 14:17:17
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
175.3Initial Entry
3. Unit:
Date Location User Value Reason
Sep-08-2020 14:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgIn tial Entry
4. Height:
Date Location User Value Reason
Sep-08-2020 14:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  a to que y
( utoqu y)Query 1: Closed C e Auto Query
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
   
  
    
    
   
   
   
  
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909099
Page 91 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-08-2020 14:17:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
175.3Transcription Error
Sep-08-2020 14:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Height 71.8 is
outside of Normal
Range 140 - 198
for cm or 55 - 80
for in.
ep-08-2020 14:17:17
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
71.8Initial Entry
5. Unit:
Date Location User Value Reason
ep-08-2020 14:17:17
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
ep-08-2020 14:17:54
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.4Transcription Error
ep-08-2020 14:17:36
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
57.0Transcription Error
Sep-08-2020 14:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
340.0nitial Entry
7.a
Date Location User Value Reason
Sep-08-2020 14:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 98.1Initial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)I  
 
I  
I 
I   
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909100
Page 92 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITY
7.a Record Identifier:
Date Location User Value Reason
Sep-08-2020 14:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-08-2020 14:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-08-2020 14:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-08-2020 14:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
 
  
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909101
Page 93 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-08-2020 14:14:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020In tial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-08-2020 14:15:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
254333In tial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
   
 
    
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909102
Page 94 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 14:15:34
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  aut  calc
(au ocalc)D a Entry:
SI EIn ial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 14:15:34
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(aut calc)Data Entry:
SERUMIn ial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 14:15:46
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  au  query
(a oquery)Query 1: Deleted Close Auto Query
Sep-08-2020 14:15:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-08-2020 14:15:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 14:15:46
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
I    
    
I    
  
I    
    
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909103
Page 95 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sample ID: BN5YMX
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 14:15:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN5YMXInitial Entry
5.b
Date Location User Value Reason
Sep-08-2020 14:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLB61BInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-08-2020 14:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLB61BInitial Entry
5.c
Date Location User Value Reason
Sep-08-2020 14:16:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLB60MInit  Entry
5.c Sample ID
Date Location User Value Reason
Sep-08-2020 14:16:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLB60MInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
  
    
  1  
 
    
    
 
   
   
 
   
    
 
    
    
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909104
Page 96 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 14:14:27
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  aut  calc
(au ocalc)D a Entry:
SI EIn ial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 14:14:27
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(aut calc)Data Entry:
NASAL_SWABIn ial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020 14:14:40
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  au  query
(a oquery)Query 1: Deleted Close Auto Query
Sep-08-2020 14:14:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-08-2020 14:14:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/8/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 14:14:40
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
I    
    
I    
  
I    
    
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909105
Page 97 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sample ID: BN66P7
5.a Sample ID
Date Location User Value Reason
Sep-08-2020 14:14:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN66P7Initial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
  
    
  1  
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909106
Page 98 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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-08-2020 14:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 14:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 14:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-08-2020 14:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020 13:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 14:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
     
 C ~  
   
   
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909107
Page 99 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-08-2020 14:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-08-2020 14:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-08-2020 14:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-08-2020 14:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
l  L 
 
 
 
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909108
Page 100 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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-08-2020 14:13:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909109
Page 101 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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-28-2020 19:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020In tial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
   
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909110
Page 102 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-28-2020 19:53:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020In tial Entry
2.a
Date Location User Value Reason
Sep-28-2020 19:53:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 98.3
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-28-2020 19:53:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1In tial Entry
2.a Temperature:
Date Location User Value Reason
Sep-28-2020 19:53:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.3In tial Entry
2.a Unit:
Date Location User Value Reason
Sep-28-2020 19:53:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FI itial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
   
  
  
   
  
   
   
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909111
Page 103 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.a Temperature Location:
Date Location User Value Reason
Sep-28-2020 19:53:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)~==~  
 
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909112
Page 104 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-28-2020 19:54:10
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  aut  calc
(au ocalc)D a Entry:
SI EIn ial Entry
2. Sample Type
Date Location User Value Reason
Sep-28-2020 19:54:10
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(aut calc)Data Entry:
NASAL_SWABIn ial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-28-2020 19:54:27
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  au  query
(a oquery)Query 1: Deleted Close Auto Query
Sep-28-2020 19:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-28-2020 19:54:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/28/2020Initial Entry
5.a
Date Location User Value Reason
Sep-28-2020 19:54:27
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
I    
    
I    
  
I    
    
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909113
Page 105 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sample ID: BN66WC
5.a Sample ID
Date Location User Value Reason
Sep-28-2020 19:54:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN66WCInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
  
    
  1  
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909114
Page 106 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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-28-2020 19:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-28-2020 19:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-28-2020 19:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-28-2020 19:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/28/2020 15:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-28-2020 19:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
     
 C ~  
   
   
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909115
Page 107 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-28-2020 19:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-28-2020 19:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-28-2020 19:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-28-2020 19:55:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
l  L 
 
 
 
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909116
Page 108 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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-26-2020 16:16:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020In tial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
   
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909117
Page 109 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 16:17:03
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  aut  calc
(au ocalc)D a Entry:
SI EIn ial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 16:17:03
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(aut calc)Data Entry:
SERUMIn ial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-26-2020 16:17:17
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  au  query
(a oquery)Query 1: Deleted Close Auto Query
Oct-26-2020 16:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-26-2020 16:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/26/2020Initial Entry
5.a
Date Location User Value Reason
Oct-26-2020 16:17:17
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
I    
    
I    
  
I    
    
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909118
Page 110 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sample ID: BRVKWC
5.a Sample ID
Date Location User Value Reason
Oct-26-2020 16:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRVKWCInitial Entry
5.b
Date Location User Value Reason
Oct-26-2020 16:17:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRVKVMInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-26-2020 16:17:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRVKVMInitial Entry
5.c
Date Location User Value Reason
Oct-26-2020 16:17:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPW0D3Init  Entry
5.c Sample ID
Date Location User Value Reason
Oct-26-2020 16:17:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPW0D3Initial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
  
    
  1  
 
    
    
 
   
   
 
   
    
 
    
    
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909119
Page 111 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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-26-2020 16:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/26/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-26-2020 16:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-26-2020 16:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
 
 
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909120
Page 112 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-27-2020 08:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)       
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909121
Page 113 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
    
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909122
Page 114 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-27-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
    
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909123
Page 115 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
    
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909124
Page 116 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 08:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 08:44:50
(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
Oct-31-2020 12:33:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-30-2020 14:56:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Drug: Heroin
Oct-29-2020 09:45:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened clinical: AE dx of
hypomagnesemia
has a causality of
drug overdose, does
this apply to
hypokalemia as
well? Pls advise
what drug pt
overdosed with.
Oct-28-2020 00:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-27-2020 16:26:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered will provide follow
up
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
 l  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909125
Page 117 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-27-2020 16:10:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical - please
submit additional
clinical course
information
including
symptoms, lab
values, evaluation
when medical
records are available
Oct-27-2020 08:44:50
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  D ta Entry:
H pokalemianitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 08:44:50
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  D a Entry:
Oc /23/2020 UNK:UNKInit  Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-27-2020 08:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/24/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-27-2020 16:49:52
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2N w Information
Oct-27-2020 08:44:50
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3In tial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)I     
 
     I    
 
    
 
   I    
I    
 
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909126
Page 118 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes)
Date Location User Value Reason
Oct-29-2020
04:31:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Event downgraded in both
database. Issue resolved
Oct-28-2020
08:05:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered confirmed
Oct-28-2020
05:17:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Open
edSAE RECON 1: Please
clarify response. Kindly
confirm if hypokalemia
event is a non serious
event.
Oct-28-2020
05:02:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered follow up SAE submitted...
resulted in making these
changes
Oct-28-2020
00:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Oct-27-2020
22:32:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened SAE
RECON:AER#2020415415
hypokalemia(onset
date:23Oct2020)was
reported as serious in
Safety database but non
serious in AE CRF. Please
confirm and update CRF. If
safety update is required,
submit a follow-up SAE
Form
Oct-27-2020
16:50:19ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered updated information
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
  
  
  
: =  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909127
Page 119 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern
Time (US & Canada)
Oct-27-2020
16:50:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-27-2020
16:50:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOupdated information
Oct-27-2020
16:09:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL - SAE states
subject went to ER but
unsure "if he was
hospitalized or retained for
observation in ER". The
only SAE criterion is
Hospitalization. Consider if
Med Important or other
would be applicable for the
definite ER visit; >1 box is
OK
Oct-27-2020
08:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Hypokalemia:
Response to "Is the adverse
event serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Oct-27-2020
08:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event ass
ociated with congenital
anomaly or birth defect
?
NO
Did this serious event r
esult in death?
NO
Did this serious event r
equire or prolong hospiInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909128
Page 120 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
talization?
YES
Did this serious event r
esult in persistent or si
gnificant disability/inca
pacity?
NO
Is this serious event lif
e threatening?
NO
Other medically import
ant serious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-27-2020 08:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOIn tial Entry
9. Is this event related to study treatment:
Date Location U er Value Reason
Nov-07-2020 07:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  haru
SabharwalQuery 1: Closed causality updated to
heroin overdose.
Nov-06-2020 05:11:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Nov-06-2020 05:11:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:New Information
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
   
  1  
  
   
    
 
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909129
Page 121 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
OTHER
If Other, specify:
heroin overdose
Nov-05-2020 14:43:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clinical - Unfrozen;
Thank you for
reviewing Other
relationship
Nov-03-2020 05:52:09
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered please unfreeze to
allow for updating
thanks
Nov-02-2020 23:38:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical -
Hypokalemia event
'Other' relationship
= Unknown;
however,
relationship for
hypomagnesemia is
Overdose with
heroin. Please
review reported
relationships for the
2 metabolic events,
and update as
appropriate
Oct-27-2020 08:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
unkInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-27-2020 08:44:50
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
  
I    
 
    
  , 
  
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909130
Page 122 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-27-2020 08:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESIn tial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 08:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInit  Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-27-2020 08:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDIn tial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 08:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOIn tial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
  
     
  1  
  
     
  1  
  
     
  1  
 
    
    
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909131
Page 123 of 152
***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, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Muscle Sprain (Right Leg)Initial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-13-2020 04:39:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mark Harre
(pfe harrem05)Query 1: Closed Response satisfies
query
Nov-11-2020 15:14:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered confirmed
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
~  1 
  
  
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909132
Page 124 of 152
***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, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-11-2020 14:13:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Please confirm if
AE is still
ongoing, if not
please provide a
stop date
Nov-11-2020 10:46:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mark Harre Query 1: Candidate Please confirm if
AE is still
ongoing, if not
please provide a
stop date
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial En y
6. Toxicity Grade:
Date Location User Value Reason
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909133
Page 125 of 152
***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, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
unkInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 16:52:16
(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
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
 
 
 
 
   
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909134
Page 126 of 152
***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, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 16:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)~==~-===-=  
 
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909135
Page 127 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-16-2020
14:17:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies query
Nov-16-2020
13:36:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered Changed Information
Nov-16-2020
13:36:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Heroin OverdoseChanged Information
Nov-16-2020
13:16:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Erica Weaver Query 4: Reissued:Open
edForm is unfrozen for you
Nov-16-2020
13:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered please unfreeze to allow for
editing
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
~  1 
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0909136
Page 128 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-16-2020
10:20:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened CLINICAL - please update
term to Heroin Overdose;
current generic word 'drug'
can be misinterpreted as
overdose of the
investigational product
Nov-16-2020
10:18:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Invalidation has highest
escalation in Safety (coding
believes subject OD'd on IP,
based on event term)
Nov-16-2020
05:45:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened SAE
RECON:AER#2020415415,
accidental overdose was
invalidated in SDB with
reason 'per protocol
overdose is reportable to
Safety only when associated
with an SAE'. Please clarify
event term and update AE
CRF and Safety database
accordingly.
Nov-02-2020
16:21:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Nov-02-2020
15:13:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Changed data per query
Nov-02-2020
14:09:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Open
edGPDCLIN: Please add
“heroin overdose” to the
“other” section of the
“relationship of study
treatment” to allow clarity
of the cause.
Oct-30-2020
14:55:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Drug Involved: Heroin
Oct-28-2020 ACV0PFEINFP6000  Query 2: Opened GPDCLIN: Accidental drug
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
  
 
  
 
  
 
   
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0909137
Page 129 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
13:21:08
(UTC-05:00) Eastern
Time (US & Canada)overdose is reported. Please
clarify the medication
involved and the indication.
Oct-28-2020
13:18:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed incomplete query- new one
will be issued.
Oct-28-2020
13:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened GPDCLIN: Please clarify
which drug you are
referring to and update the
AE term as applicable.
Oct-27-2020
16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Accidental Drug Overdo
seInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/23/2020 UNK:UNKInitia  Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-27-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/24/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-01-2020 03:55:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-30-2020 14:51:37
(UTC-05:00) EasternACV0PFEINFP6000  au  query
(a oquery)Query 1: Answered Ch nged
Inf rmation
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
 
  
 
 
 
     
    
 
  
 
   
   I 
    
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909138
Page 130 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
Oct-30-2020 14:51:37
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Changed
I formation
Oct-28-2020 13:23:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened GPDCLIN: Grade
3 AE is listed
however, the SAE
criteria listed as
met is a life
threatening event.
please review and
confirm the grade.
Oct-27-2020 16:54:56
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).
Date Location User Value Reason
Nov-05-2020 14:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Query closed; will
follow for SAE
update with the
heroin overdose info
Nov-03-2020 10:44:44
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered linical team
notified
Nov-02-2020 23:35:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened CLINICAL Please
submit the
information
concerning heroin
overdose as a SAE
safety update
Oct-29-2020 04:33:56
UTC-05:00) EasternACV0PFEINFP6000  Query 2: Closed Event entered in
nform
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)     
 I    
I  1  
    
 I    
   I  
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909139
Page 131 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
Oct-28-2020 05:58:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed internally
Oct-28-2020 05:57:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE RECON:
Accidental Drug
Overdose(Onset
date:23Oct2020) is
not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the
event on AE CRF
Oct-27-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Accidental
Drug Overdose:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-27-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requir
e or prolong hospitalization
?Initial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
 
    
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0909140
Page 132 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
NO
Did this serious event result
in persistent or significant di
sability/incapacity?
NO
Is this serious event life thre
atening?
YES
Other medically important s
erious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oc -27 2020 16 54:56
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-02-2020 15:13:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
heroin overdoseNew Information
Oct-28-2020 13:17:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed incomplete query.
new one will be
issued.
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)r---  
 1 r  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0909141
Page 133 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-28-2020 12:11:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical - please
pecify which drug
was overdosed, in
he 'Other' rea on
Oct-27-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
overdoseInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-27-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-27-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 16:54:56
(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
Oct-27-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)r=----  J J 
 
 
 
 
 
 
 
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909142
Page 134 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 16:54:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOIn  Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-29-2020 04:33:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020415415In tial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
    
  
    
  1  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909143
Page 135 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
( utocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypomagnesemiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/24/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
~  1 
  
  
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909144
Page 136 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-02-2020 16:22:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-02-2020 15:14:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Nov-02-2020 15:14:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHERNew Information
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909145
Page 137 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
If Other, specify:
heroin overdose
Nov-02-2020 14:07:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened GPDCLIN: Please
add “heroin
overdose” to this
“If other, specify: ”
section, to allow
clarity of the
cause.
t-30-2020 14:56:26
( TC-05:00) Eastern
me (US & Canada)ACV0PFEINFP6000  Query 1: Answered Drug: Heroin
Oct-28-2020 13:40:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened GPDCLIN:
accidental
overdose is listed
as the cause of this
AE. Please specify
the drug and
indication.
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
accidental overdoseInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-27-2020 16:57:27
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)_  
 
 
I 
  
 
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909146
Page 138 of 152
***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, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-27-2020 16:57:27
(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
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-27-2020 16:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
 
 
 
 
  
 1=i .  
  
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909147
Page 139 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - Audit Trail
Form Version: 17-Jul-2020 21:54 Form Status:
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Oct-12-2020 16:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
    
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909148
Page 140 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Oct-12-2020 16:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
MEDICATION ERRORInitial Entry
2. Medication Error (Type of Medication Error):
Date Location User Value Reason
Oct-12-2020 16:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SUBJECT DOSED WITH IP T
HAT HAD TEMPERATURE E
XCURSION (PRODUCT STO
RAGE ERROR)Initial Entry
3. Start Date:
Date Location User Value Reason
Oct-12-2020 16:59:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/8/2020Transcription Error
Oct-12-2020 16:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
4. Is the medication error still ongoing?
Date Location User Value Reason
Oct-12-2020 16:59:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-12-2020 16:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened End date
08/Sep/2020 is not
equal to the Start
date 08/Oct/2020.
Please review and
update as
appropriate.
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
 
 
 
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909149
Page 141 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-12-2020 16:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Sep/8/2020Initial Entry
5. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-12-2020 16:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO ACTION TAKENInitial Entry
6. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-12-2020 16:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
7. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-12-2020 16:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Did the Medication Error cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-12-2020 16:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Was this medication error associated with any adverse events?
Date Location User Value Reason
Oct-12-2020 16:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909150
Page 142 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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-08-2021 18:52:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/28/2021In tial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   
   
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909151
Page 143 of 152
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 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 ValueReason
Mar-08-2021
00:09:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies
query
Mar-05-2021
13:47:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dappropriate
Mar-05-2021
04:53:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
2: Op
enedDMW7607751;The
participant is
willing to return
for Vaccination 3,
but the Primary
Reason for
Unblinding in the
Treatment
Unblinded CRF is
not ASSESS
ELIGIBILITY
FOR
ADDITIONAL
VACCINATION.
Please review and
update as
appropriate.
Feb-08-2021
18:53:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Del
etedClose Auto Query
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909152
Page 144 of 152
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-08-2021
18:53:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ca
ndidat
eThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-08-2021
18:53:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Partic
ipant i
s willi
ng to
return
for Va
ccinat
ion 3
Parti
cipa
nt is:
eli
gib
le
an
d
N
OT
co
nfi
rm
ed
to
ha
ve
rec
eiv
ed
onl
y pInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0909153
Page 145 of 152
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
lac
eb
o a
t V
acc
ina
tio
n 1
/2
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)
(b) (4)
FDA-CBER-2021-5683-0909154
Page 146 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-04-2021 04:30:09
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-02-2021 16:40:48
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Mar-02-2021 04:54:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened IVRS: Date when
participant was
made aware of their
treatment
assignment (subject
was unblinded) is
expected at ‘Date
Treatment
Unblinded’ filed.
Please check and
update if this is be
matching with
(Date Blind broken
at Impala)
25Feb2021. Else,
clarify.
Mar-01-2021 04:37:34
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Feb-28-2021 20:53:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened IVRS
Reconciliation:
Date Blind broken
25Feb2021 at
Impala is not
matching with Date
treatment
Unblinded
28Jan2021. Please
check and update
data as appropriate.
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  I   I   
I   
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0909155
Page 147 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Else, clarify. Thank
you.
Feb-08-2021 18:53:25
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/28/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-25-2021 10:53:44
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-24-2021 13:30:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subjects unblinded
for TE safety
concern at v1 or v2
vax and not PA10.
Sponsor requested
subjects unblinded
in Impala on
23/24Nov2020
(prior to PA10) and
unblinding
explained to each.
unblinding not done
in Impala/IRT
which has resulted
in a IRT mismatch
Feb-23-2021 03:02:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened IVRS
Reconciliation:
Subject Safety
Concern is selected
as the primary
reason for
un-blinding but
matching blind
break is not
captured in IRT.
Please correct
primary reason in
Inform or confirm
as correct”.
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)   I    
  
  I   
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909156
Page 148 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-19-2021 05:30:21
UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SUBJECT SAFETY CONCE
RNTranscription Error
Feb-08-2021 18:53:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)I    
 
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909157
Page 149 of 152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Feb-08-2021 18:53:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableIn tial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
   
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909158
Page 150 of 152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Feb-08-2021 18:54:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableIn tial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT) 
    
   
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909159
Page 151 of 152
***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: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-26-2020 16:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-08-2020 14:14:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-08-2020 14:13:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000   
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-26-2020 16:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  uto calc
(autocalc)Data Entry:
Oct/26/2020Initial Entry
Sep-08-2020 14:14:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/8/2020Initial Entry
Sep-08-2020 14:13:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/8/2020Initial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)  
  L   
         - -      -
-- -- - -      - -        
(b) (4)
FDA-CBER-2021-5683-0909160
Page 152 of 152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1044 Site Name: (1044) Virginia Research Center
Subject No: 10441093 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-06-2020 10:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableIn tial Entry
090177e196ae3e61\Final\Final On: 01-Apr-2021 04:53 (GMT)    
   
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0909161