125742 S1 M5 CRF c4591001 1116 11161198

Document text

Page 1 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979879
Page 2 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/10/2020
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979880
Page 3 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Demography
1.Subject ID [11161198]
2.Birth Date: /1946
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:
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979881
Page 4 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979882
Page 5 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979883
Page 6 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979884
Page 7 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Urinary incontinence]
Start Date: UNK/UNK/2008
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Erectile Dysfunction]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SA Node Sysfunction]
Start Date: UNK/UNK/2010
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pacemaker Implanted]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979885
Page 8 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tachy Brady Heart Rate]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral Knee Replacement]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[No cartilage in knees]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tonsillectomy]
Start Date: UNK/UNK/1958
Ongoing: NO
End Date:
UNK/UNK/1958
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979886
Page 9 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillitis]
Start Date: UNK/UNK/1958
Ongoing: NO
End Date:
UNK/UNK/1958
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Appendicitis]
Start Date: UNK/UNK/1960
Ongoing: NO
End Date:
UNK/UNK/1960
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Appendectomy]
Start Date: UNK/UNK/1960
Ongoing: NO
End Date:
UNK/UNK/1960
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cataract bilateral eye surgery]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979887
Page 10 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cataracts Bilateral]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthritis]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979888
Page 11 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
2.Weight: [199.2]
3.Unit: LB
4.Height: [72.0]
5.Unit: in
6.Body Mass Index: [27.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979889
Page 12 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [257588]
3.Randomization Group: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979890
Page 13 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN65JM]
5.bSample ID [BN65JN]
5.cSample ID [BLBFLK]
5.dSample ID [BLBFLL]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979891
Page 14 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN65F0]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979892
Page 15 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/10/2020 17:25
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979893
Page 16 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979894
Page 17 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979895
Page 18 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979896
Page 19 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP4165]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979897
Page 20 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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/29/2020 17:04
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979898
Page 21 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/27/2020
2.Erroneous Visit
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979899
Page 22 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/27/2020
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 [BPMFN8]
5.bSample ID [BPMFN9]
5.cSample ID [BP414W]
5.dSample ID [BP414X]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979900
Page 23 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979901
Page 24 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979902
Page 25 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979903
Page 26 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979904
Page 27 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979905
Page 28 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979906
Page 29 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979907
Page 30 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979908
Page 31 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979909
Page 32 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Unplanned Assessments
1.Assessments
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979910
Page 33 of 178
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/27/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979911
Page 34 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979912
Page 35 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979913
Page 36 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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 [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979914
Page 37 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  PULMONARY EMBOLISM/ BLOOD
CLOTS IN UPPER RIGHT LOBE Dec/22/2020
UNK:UNK NO
End Date Time:
Dec/22/2020 UN
K:UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  slow to recover from anesthesia  Dec/2/2020 U
NK:UNK NO
End Date Time:
Dec/3/2020 UNK:
UNK
 Repeating
Pages
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979915
Page 38 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[PULMONARY EMBOLISM/ BLOOD CLOTS IN UPPER RIGHT LOBE]
4.Start Date Time: Dec/22/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/22/2020 UNK:UNK
6.Toxicity Grade: 3
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
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979916
Page 39 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[complication from shoulder surgery]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021247388]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979917
Page 40 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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)[slow to recover from anesthesia]
4.Start Date Time: Dec/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/3/2020 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).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
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979918
Page 41 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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:
[complication to shoulder surgery]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979919
Page 42 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979920
Page 43 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979921
Page 44 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979922
Page 45 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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: //
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979923
Page 46 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979924
Page 47 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979925
Page 48 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979926
Page 49 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979927
Page 50 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979928
Page 51 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979929
Page 52 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979930
Page 53 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979931
Page 54 of 178
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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?
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979932
Page 55 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979933
Page 56 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979934
Page 57 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979935
Page 58 of 178
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979936
Page 59 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/6/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979937
Page 60 of 178
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979938
Page 61 of 178
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979939
Page 62 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979940
Page 63 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/13/2021
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979941
Page 64 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979942
Page 65 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/13/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979943
Page 66 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTZ06]
5.bSample ID [BPTZ07]
5.cSample ID [BPMF5P]
5.dSample ID [BPMF5R]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979944
Page 67 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/13/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP40XK]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979945
Page 68 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/13/2021 13:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979946
Page 69 of 178
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979947
Page 70 of 178
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/3/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR62WG]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979948
Page 71 of 178
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/3/2021 11:18
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979949
Page 72 of 178
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979950
Page 73 of 178
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/3/2021
3.Comments: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979951
Page 74 of 178
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979952
Page 75 of 178
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979953
Page 76 of 178
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979954
Page 77 of 178
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979955
Page 78 of 178
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Mar/3/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979956
Page 79 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/27/2020
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979957
Page 80 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979958
Page 81 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Paul Matherne  Approved Mar-12-2021 12:18:07 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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.
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979959
Page 82 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormSep-10-2020 18:42:37 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979960
Page 83 of 178
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
ItemDate User Comment
FormJan-27-2021 12:24:06 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979961
Page 84 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Paul Matherne  Approved Mar-12-2021 12:18:07 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-11-2021 07:53:06 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Paul Matherne  Approved Mar-04-2021 18:51:12 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-27-2021 12:22:15 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979962
Page 85 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Paul Matherne  Approved Nov-02-2020 18:23:04 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, PaulMatherne, 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.
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979963
Page 86 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-10-2020 18:41:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-10-2020 18:41:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979964
Page 87 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-10-2020 18:42:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Sep/10/2020Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979965
Page 88 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-10-2020 18:41:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11161198Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Feb-22-2021 13:42:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Transcription Error
Feb-22-2021 13:42:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
/1946Transcription Error
Feb-17-2021 00:09:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 1: Candidate Based on the site
response for SAE
query, year of birth
to be updated to
1946
Sep-10-2020 18:41:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1949Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-10-2020 18:42:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-10-2020 18:42:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979966
Page 89 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-10-2020 18:42:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979967
Page 90 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020 18:42:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979968
Page 91 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-10-2020 18:42:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-10-2020 18:42:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-10-2020 18:42:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979969
Page 92 of 178
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.a
Date Location User Value Reason
Sep-10-2020 18:49:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Urinary inconti
nence
Start Date: UNK/UNK/20
08
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:49:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:49:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Urinary incontinenceInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-10-2020 18:49:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-10-2020 18:49:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979970
Page 93 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.b
Date Location User Value Reason
Sep-10-2020 18:50:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Erectile Dysfu
nction
Start Date: UNK/UNK/20
15
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:50:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:50:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Erectile DysfunctionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-10-2020 18:50:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-10-2020 18:50:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979971
Page 94 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-10-2020 18:51:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:SA Node Sysfu
nction
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:51:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:51:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SA Node SysfunctionInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-10-2020 18:51:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-10-2020 18:51:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979972
Page 95 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-10-2020 18:52:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:Pacemaker Impl
anted
Start Date: UNK/UNK/201
0
Ongoing: NO
End Date:
UNK/UNK/
2010Initial Entry
1.d Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:52:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:52:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Pacemaker ImplantedInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-10-2020 18:52:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-10-2020 18:52:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979973
Page 96 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.e
Date Location User Value Reason
Sep-10-2020 18:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Tachy Brady Hea
rt Rate
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2
010Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979974
Page 97 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.e Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Tachy Brady Heart RateInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-10-2020 18:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-10-2020 18:54:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.f
Date Location User Value Reason
Sep-10-2020 18:55:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Histo
ry Term:Bilateral Knee Re
placement
Start Date: UNK/UNK/2014Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979975
Page 98 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing: NO
End Date:
UNK/UNK/20
14
1.f Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:55:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:55:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Bilateral Knee ReplacementInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-10-2020 18:55:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-10-2020 18:55:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.g
Date Location User Value Reason
Sep-10-2020 18:55:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979976
Page 99 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical History
Term:No cartilage in
knees
Start Date: UNK/UNK/201
4
Ongoing: NO
End Date:
UNK/UNK/
2014
1.g Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:55:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:55:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
No cartilage in kneesInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-10-2020 18:55:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-10-2020 18:55:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.h
Date Location User Value Reason
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979977
Page 100 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-10-2020 18:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:tonsillectomy
Start Date: UNK/UNK/195
8
Ongoing: NO
End Date:
UNK/UNK/
1958Initial Entry
1.h Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
tonsillectomyInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-10-2020 18:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1958Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-10-2020 18:56:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1958Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979978
Page 101 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.i
Date Location User Value Reason
Sep-10-2020 18:56:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:Tonsillitis
Start Date: UNK/UNK/195
8
Ongoing: NO
End Date:
UNK/UNK/
1958Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979979
Page 102 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.i Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:56:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:56:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TonsillitisInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-10-2020 18:56:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1958Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-10-2020 18:56:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1958Initial Entry
1.j
Date Location User Value Reason
Sep-10-2020 18:57:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:10
Medical History
Term:Appendicitis
Start Date: UNK/UNK/196
0Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979980
Page 103 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing: NO
End Date:
UNK/UNK/
1960
1.j Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:57:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:57:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AppendicitisInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-10-2020 18:57:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1960Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-10-2020 18:57:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1960Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979981
Page 104 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1.k
Date Location User Value Reason
Sep-10-2020 18:57:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical History
Term:Appendectomy
Start Date: UNK/UNK/19
60
Ongoing: NO
End Date:
UNK/UNK/
1960Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0979982
Page 105 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
1.k Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:57:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:57:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AppendectomyInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-10-2020 18:57:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1960Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-10-2020 18:57:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1960Initial Entry
1.l
Date Location User Value Reason
Sep-10-2020 18:58:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:12
Medical Histo
ry Term:Cataract bilateral e
ye surgery
Start Date: UNK/UNK/2010Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979983
Page 106 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Ongoing: NO
End Date:
UNK/UNK/20
10
1.l Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:58:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:58:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cataract bilateral eye surgeryInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-10-2020 18:58:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-10-2020 18:58:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.m
Date Location User Value Reason
Sep-10-2020 18:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:13Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979984
Page 107 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Medical History
Term:Cataracts Bilat
eral
Start Date: UNK/UNK/20
10
Ongoing: NO
End Date:
UNK/UNK/
2010
1.m Line/MH Number:
Date Location User Value Reason
Sep-10-2020 18:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 18:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cataracts BilateralInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-10-2020 18:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-10-2020 18:58:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.n
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979985
Page 108 of 178
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-10-2020 19:00:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:14
Medical History T
erm:osteoarthritis
Start Date: UNK/UNK/2
016
Ongoing: YESInitial Entry
1.n Line/MH Number:
Date Location User Value Reason
Sep-10-2020 19:00:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 19:00:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
osteoarthritisInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-10-2020 19:00:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-10-2020 19:00:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979986
Page 109 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020 18:45:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-10-2020 18:45:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Transcription Error
Sep-10-2020 18:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Vital signs Date
10/Aug/2020 is not
same as Date of
Visit 10/Sep/2020.
Please review and
update as
appropriate or
clarify.
Sep-10-2020 18:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-10-2020 18:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
199.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-10-2020 18:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979987
Page 110 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Sep-10-2020 18:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
72.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-10-2020 18:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-10-2020 18:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27.0Initial Entry
7.a
Date Location User Value Reason
Sep-10-2020 18:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.4
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 18:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-10-2020 18:43:47
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
98.4Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0979988
Page 111 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
7.a Unit:
Date Location User Value Reason
Sep-10-2020 18:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-10-2020 18:43:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979989
Page 112 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-10-2020 18:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-10-2020 18:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
257588Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979990
Page 113 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 18:44:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 18:44:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-10-2020 23:31:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-10-2020 18:44:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 18:44:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
5.a
Date Location User Value Reason
Sep-10-2020 23:31:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
Sample ID: BN65JMInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979991
Page 114 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Sep-10-2020 23:31:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
BN65JMInitial Entry
5.b
Date Location User Value Reason
Sep-10-2020 23:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
Sample ID: BN65JNInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-10-2020 23:31:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
BN65JNInitial Entry
5.c
Date Location User Value Reason
Sep-10-2020 23:32:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
Sample ID: BLBFLKInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-10-2020 23:32:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
BLBFLKInitial Entry
5.d
Date Location User Value Reason
Sep-10-2020 23:32:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
Sample ID: BLBFLLInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979992
Page 115 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Sep-10-2020 23:32:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
BLBFLLInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979993
Page 116 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 18:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 18:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020 08:19:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-11-2020 04:31:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 18:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 18:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0979994
Page 117 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a
Date Location User Value Reason
Sep-11-2020 08:19:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
Sample ID: BN65F0Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-11-2020 08:19:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Heather
LambertData Entry:
BN65F0Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0979995
Page 118 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020 18:45:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020 18:45:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020 18:45:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020 18:45:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 17:25Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 18:45:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020 18:45:02
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979996
Page 119 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-10-2020 18:45:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020 18:45:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-10-2020 18:45:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979997
Page 120 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-10-2020 18:45:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979998
Page 121 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020 17:25:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0979999
Page 122 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date:
Date Location User Value Reason
Sep-29-2020 17:25:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
2.a
Date Location User Value Reason
Sep-29-2020 17:25:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.4
Temperature Unit: F
Temperature Loca
tion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-29-2020 17:25:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-29-2020 17:25:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-29-2020 17:25:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0980000
Page 123 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Sep-29-2020 17:25:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980001
Page 124 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 17:26:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 17:26:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 10:20:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-30-2020 03:28:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-29-2020 17:26:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-29-2020 17:26:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0980002
Page 125 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a
Date Location User Value Reason
Oct-01-2020 10:20:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP4165Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-01-2020 10:20:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP4165Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980003
Page 126 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-29-2020 17:26:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-29-2020 17:26:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-29-2020 17:26:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-29-2020 17:26:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020 17:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-29-2020 17:26:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-29-2020 17:26:25
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980004
Page 127 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-29-2020 17:26:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-29-2020 17:26:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-29-2020 17:26:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980005
Page 128 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-30-2020 12:00:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980006
Page 129 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-30-2020 12:00:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-30-2020 12:00:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 12:00:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-30-2020 12:00:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-30-2020 12:00:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/27/2020Initial Entry
5.a
Date Location User Value Reason
Oct-30-2020 12:00:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPMFN8Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980007
Page 130 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Oct-30-2020 12:00:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPMFN8Initial Entry
5.b
Date Location User Value Reason
Oct-30-2020 12:01:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPMFN9Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-30-2020 12:01:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPMFN9Initial Entry
5.c
Date Location User Value Reason
Oct-30-2020 12:01:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP414WInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-30-2020 12:01:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP414WInitial Entry
5.d
Date Location User Value Reason
Oct-30-2020 12:01:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP414XInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0980008
Page 131 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d Sample ID
Date Location User Value Reason
Oct-30-2020 12:01:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP414XInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980009
Page 132 of 178
***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, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-03-2020 08:35:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-02-2020 18:22:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Nov-02-2020 18:22:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/27/2020Initial Entry
Nov-02-2020 11:33:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please complete the
End of Treatment
CRF. Per
Guidelines, If the
Participant receives
all vaccinations as
per protocol and
completes the
follow-up visit
procedures within
the 1-month post
vaccination period,
report the status as
COMPLETED.
2. Phase of Disposition:
Date Location User Value Reason
Nov-02-2020 18:22:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-02-2020 18:22:31 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980010
Page 133 of 178
***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, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
(UTC-06:00) Central
Time (US & Canada)COMPLETED
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980011
Page 134 of 178
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Jan-27-2021 14:08:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0980012
Page 135 of 178
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
Date Location User Value Reason
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0980013
Page 136 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Jan-27-2021 14:08:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-27-2021 14:08:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021 13:53:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Closed Deferring to DSU.
Thank you
Mar-12-2021 10:54:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Transcription error
Mar-11-2021 12:48:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Reissued:Opened Thank you for the
response. Was this a
transcription error?
Mar-11-2021 07:52:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered No infection,
pulmonary
embolism location
Mar-10-2021 12:34:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Opened Medical Monitor_
Pls advice on
symptoms of onset,
and additional
diagnosis on
discharge -per
report "primary
infection in lungs"-
kindly clarify type
of infection.
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0980014
Page 137 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Feb-01-2021 07:53:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PULMONARY EMBOLISM/
BLOOD CLOTS IN UPPER RI
GHT LOBEChanged
Information
Jan-29-2021 14:15:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Jan-28-2021 17:50:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered left reverse shoulder
arthoplasty
02Dec2020
Jan-28-2021 12:30:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD Clin: Did
subject have risk
factors for PE, e.g.
recent prolonged
travel, injury,
surgery, medical
history of DVT,
etc? Thanks
Jan-27-2021 14:08:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Blood Clots right upper lung lo
beChanged
Information
Jan-27-2021 14:08:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Blood Clots right upper lobeInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-12-2021 10:53:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Mar-12-2021 10:53:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/22/2020 UNK:UNKTranscription Error
Mar-12-2021 08:12:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE RECON:
AER#2021247388 ,onset
date was recorded as
22Dec2020 in Safety
database however,
recorded as 21Dec2020
on AE CRF. Please
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (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) (4)
(b) (4)
FDA-CBER-2021-5683-0980015
Page 138 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
confirm correct Onset
Date. If safety update is
required, please submit
a follow-up SAE form.
Feb-04-2021 05:04:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed Response satisfies query
Feb-03-2021 16:04:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered added to edc
Jan-28-2021 12:32:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD Clin: please
complete lines 5 - 15 for
the AE "Blood Clots
right upper lung lobe".
Thanks
Jan-27-2021 14:08:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021 10:53:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-12-2021 10:53:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/22/2020 UNK:UNKTranscription Error
Mar-12-2021 10:53:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For PULMONARY
EMBOLISM/
BLOOD CLOTS IN
UPPER RIGHT
LOBE End Date &
Time 21/Dec/2020
UNK:UNK is before
the Start Date &
Time 22/Dec/2020
UNK:UNK.
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0980016
Page 139 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Feb-03-2021 15:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/21/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-03-2021 16:03:13
(UTC-06:00) Central
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
Mar-11-2021
22:26:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 5: Closed Response satisfies query
Mar-11-2021
22:23:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Deleted Close Auto Query
Mar-11-2021
07:53:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 6: Candidate For AE PULMONARY
EMBOLISM/ BLOOD
CLOTS IN UPPER RIGHT
LOBE : Response to "Is the
adverse event serious?" is
'Yes' but "Serious Adverse
Event Number" is blank.
Mar-11-2021
07:53:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 5: Answered Changed Information
Mar-11-2021 ACV0PFEINFP6000  Data Entry: Changed Information
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0980017
Page 140 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
07:53:06
(UTC-06:00) Central
Time (US & Canada)YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
NO
Did this serious event res
ult in death?
NO
Did this serious event req
uire or prolong hospitaliz
ation?
NO
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
YES
Other medically importa
nt serious event
NO
Mar-10-2021
06:18:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 5: Opened SAE
RECON:AER#2021247388
Pulmonary embolism is
still reported as an SAE in
Safety database.Per
previous query ''Pulmonary
Embolism did not prolong
hospitalization.'. Please
confirm if follow up SAE
form was sent to
downgrade event in Safety
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980018
Page 141 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Mar-08-2021
17:04:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 4: Closed Response satisfies query
Mar-04-2021
16:58:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Information submitted
Mar-04-2021
16:05:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 4: Reissued:Opened Thank you for your prompt
response. Pls submit a FU
letter with this information
so it is added to the safety
narrative
Mar-04-2021
15:05:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Pulmonary Embolism did
not prolong
hospitalization.Subject was
prescribed medication and
discharged home.
Mar-04-2021
14:54:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 4: Reissued:Opened Thanks for confirming,
Could your please confirm
this event did not prolong
hospital stay and/or was
considered
Life-threatening?
Mar-02-2021 11:11:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Downgraded per PI
Mar-01-2021
09:40:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 4: Opened Medical monitor_ Per
protocol section 10.3.2
Definition of SAE, this
type of events are
considered serious. Pls
advise reason for
downgrading to
non-serious. Thanks
Feb-22-2021 15:38:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies query
Feb-22-2021 14:10:31
(UTC-06:00) CentralACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Changed Information
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0980019
Page 142 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
Feb-22-2021 14:10:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOChanged Information
Feb-17-2021 02:00:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened SAE
RECON:PULMONARY
EMBOLISM/ BLOOD
CLOTS IN UPPER RIGHT
LOBE 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
Feb-16-2021 02:44:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Deleted Query can be addressed
internally
Feb-12-2021 13:18:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Feb-12-2021 13:10:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE PULMONARY
EMBOLISM/ BLOOD
CLOTS IN UPPER RIGHT
LOBE : Response to "Is the
adverse event serious?" is
'Yes' but "Serious Adverse
Event Number" is blank.
Feb-12-2021 13:10:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-12-2021 13:10:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
NO
Did this serious event resTranscription Error
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0980020
Page 143 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
ult in death?
NO
Did this serious event req
uire or prolong hospitaliz
ation?
NO
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
YES
Other medically importa
nt serious event
NO
Feb-04-2021 13:43:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened clinical: pls confirm AE
does not meet seriousness
criteria or notify sponsor
immediately. Thanks
Feb-03-2021 15:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-03-2021 15:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0980021
Page 144 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-04-2021 13:21:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Feb-04-2021 12:11:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-04-2021 12:11:35
(UTC-06:00) Central
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:
complication from shoul
der surgeryNew Information
Feb-04-2021 05:04:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD Clin: Per
previous query
response AE
"PULMONARY
EMBOLISM/
BLOOD CLOTS IN
UPPER RIGHT
LOBE" is attributed
to left reverse
shoulder arthoplasty
02Dec2020. Can
you please update
AE line #9
according to eCRF
completion guide
section 8.50.8?
Thanks
Feb-03-2021 15:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0980022
Page 145 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-03-2021 15:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-03-2021 15:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-03-2021 15:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-12-2021
15:17:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies query
Mar-12-2021
10:55:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered Recovering with medication
prescribed to dissolve clot
Mar-12-2021
10:54:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE PULMONARY
EMBOLISM/ BLOOD CLOTS IN
UPPER RIGHT LOBE : Response
to "What was the outcome of this
adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0980023
Page 146 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Mar-12-2021
10:54:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Mar-12-2021
10:54:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RE
SOLVINGTranscription Error
Mar-12-2021
08:14:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021247388,outcome
was reported as
RECOVERED/RESOLVED to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Feb-03-2021
15:28:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-03-2021 15:28:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-11-2021 22:23:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021247388Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0980024
Page 147 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Category:
Date Location User Value Reason
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-22-2021 15:40:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Year of birth updated
Feb-22-2021 13:46:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Feb-17-2021 00:14:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON:
Demography page is
unlock. PLease update Year
of birth per previous query
response.
Feb-15-2021 03:37:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candid
atePending request to unlock
from
Feb-12-2021 13:13:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Year of birth is 1946
Feb-10-2021 03:28:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021026240
the date of birth was
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0980025
Page 148 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
recorded as 1946 in
Safety database but was
recorded as 1949 in
AE CRF. Please confirm
correct date of birth. If
safety update is required,
please submit a follow-up
form.
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
slow to recover from anest
hesiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-03-2021 07:28:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed downgraded to non
serious. no
reconciliation
required
Mar-02-2021 11:12:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered submitted updated
SAE
Mar-01-2021 03:56:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON 1: If
Slow recover from
anesthesia event is
not serious. Please
submit a follow up
SAE form to
downgrade event in
Safety.
Feb-26-2021 15:32:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Slow recover from
anesthesia is down
graded to non serious
Feb-25-2021 20:32:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2021026240
,onset date was
updated to
22Dec2020 in Safety
database however,
recorded as
02Dec2020 on AE
CRF. Please confirm
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (6)
(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-2021-5683-0980026
Page 149 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
correct Onset Date. If
safety update is
required, please
submit a ffup SAEM
form.
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/2/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/3/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-05-2021 03:16:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-04-2021 12:14:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Feb-04-2021 12:14:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
Feb-04-2021 09:33:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Item incomplete
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).
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0980027
Page 150 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Date Location User Value Reason
Mar-12-2021
11:01:30 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Candidate For AE slow to recover
from anesthesia : Response
to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Mar-12-2021
11:01:30 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Changed Information
Mar-12-2021
11:01:30 (UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?
NO
Did this serious event res
ult in death?
NO
Did this serious event req
uire or prolong hospitaliz
ation?
NO
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
YES
Other medically importa
nt serious eventChanged Information
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0980028
Page 151 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
NO
Mar-12-2021
08:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened SAE
RECON:AER#2021026240
slow to recover from
anesthesia(onset
date:02dec2020)was
reported as serious in
Safety database but
nonserious in AE CRF.
Please confirm seriousness.
If safety update is required,
submit a follow-up SAE
Form.
Mar-02-2021
03:40:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Deleted Query can be addressed
internally
Feb-26-2021 16:22:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate For AE slow to recover
from anesthesia : Response
to "Is the adverse event
serious?" is 'No' but
"Serious Adverse Event
Number" is present.
Feb-26-2021 16:22:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOChanged Information
Feb-04-2021 09:32:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE slow to recover
from anesthesia : Response
to "Is the adverse event
serious?" is 'Yes' but
"Serious Adverse Event
Number" is blank.
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event asso
ciated with congenital an
omaly or birth defect?Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0980029
Page 152 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
NO
Did this serious event res
ult in death?
NO
Did this serious event req
uire or prolong hospitaliz
ation?
YES
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
NO
Other medically importa
nt 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
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-05-2021 01:54:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980030
Page 153 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Feb-04-2021 12:13:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Feb-04-2021 12:13:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
complication to shoulder
surgeryNew Information
Feb-04-2021 09:32:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Item incomplete
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0980031
Page 154 of 178
***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, Answered Queries
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-03-2021 15:51:04
(UTC-06:00) Central
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
Feb-03-2021 15:51:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-03-2021 07:28:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: downgraded to non
serious
Feb-04-2021 09:32:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021026240Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0980032
Page 155 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-27-2021 12:22:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/6/2021Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980033
Page 156 of 178
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-27-2021 12:22:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-27-2021 12:22:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-27-2021 12:22:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national rec
ommendations and confirmed
to have received only placebo
at Vaccination 1/2Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980034
Page 157 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-27-2021 12:22:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/6/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-27-2021 12:22:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980035
Page 158 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-27-2021 12:23:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980036
Page 159 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-27-2021 12:23:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/13/2021Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980037
Page 160 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-27-2021 12:24:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-27-2021 12:24:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-27-2021 12:24:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980038
Page 161 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021 12:24:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021 12:24:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-01-2021 08:44:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-28-2021 03:12:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-27-2021 12:24:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-27-2021 12:24:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/13/2021Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0980039
Page 162 of 178
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a
Date Location User Value Reason
Feb-01-2021 08:44:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTZ06Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-01-2021 08:44:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPTZ06Initial Entry
5.b
Date Location User Value Reason
Feb-01-2021 08:44:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTZ07Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-01-2021 08:44:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPTZ07Initial Entry
5.c
Date Location User Value Reason
Feb-01-2021 08:44:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPMF5PInitial Entry
5.c Sample ID
Date Location User Value Reason
Feb-01-2021 08:44:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPMF5PInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0980040
Page 163 of 178
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.d
Date Location User Value Reason
Feb-01-2021 08:45:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPMF5RInitial Entry
5.d Sample ID
Date Location User Value Reason
Feb-01-2021 08:45:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPMF5RInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980041
Page 164 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-27-2021 12:25:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-27-2021 12:25:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-27-2021 12:26:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-27-2021 12:25:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-27-2021 12:25:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/13/2021Initial Entry
5.a
Date Location User Value Reason
Jan-27-2021 12:26:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP40XKInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980042
Page 165 of 178
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Jan-27-2021 12:26:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP40XKInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980043
Page 166 of 178
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-27-2021 12:25:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-27-2021 12:25:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-27-2021 12:25:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-27-2021 12:25:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021 13:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-27-2021 12:25:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-27-2021 12:25:47
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980044
Page 167 of 178
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-27-2021 12:25:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-27-2021 12:25:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-27-2021 12:25:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-27-2021 12:25:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-27-2021 12:25:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980045
Page 168 of 178
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 14:20:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/3/2021Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0980046
Page 169 of 178
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 14:20:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 14:20:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-26-2021 14:21:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-26-2021 14:20:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-26-2021 14:20:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/3/2021Initial Entry
5.a
Date Location User Value Reason
Feb-26-2021 14:21:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR62WGInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0980047
Page 170 of 178
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
5.a Sample ID
Date Location User Value Reason
Feb-26-2021 14:21:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR62WGInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0980048
Page 171 of 178
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-26-2021 14:21:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-26-2021 14:21:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-26-2021 14:21:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-26-2021 14:21:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/3/2021 11:18Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-26-2021 14:21:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Feb-26-2021 14:21:53
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980049
Page 172 of 178
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Time (US & Canada)
7. Route:
Date Location User Value Reason
Feb-26-2021 14:21:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-26-2021 14:21:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-26-2021 14:21:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-26-2021 14:21:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-26-2021 14:21:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0980050
Page 173 of 178
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 12:42:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-04-2021 09:24:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Mar-04-2021 02:38:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Patient
completed
Vaccination 3 visit
through the
1-month post
vaccination visit
after the
Vaccination 4.
Please complete
treatment
disposition CRF
and update date of
EOT2 to match
date of visit at visit
103.
Mar-03-2021 10:40:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/3/2021Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980051
Page 174 of 178
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Contact Type:
Date Location User Value Reason
Mar-03-2021 10:40:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Mar-03-2021 10:40:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Mar/3/2021Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980052
Page 175 of 178
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Mar-05-2021
03:01:57
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_21
Mar-04-2021
18:06:18
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7602057;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Mar-04-2021
09:23:31
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Mar/3
/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-04-2021 09:23:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Mar-04-2021 09:23:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0980053
Page 176 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-02-2020 18:22:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-10-2020 18:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-10-2020 18:42:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-04-2021 11:31:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed AE entered on Log form
Feb-01-2021 08:43:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered AE WILL BE UPDATED
Jan-28-2021 08:41:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened SAE RECON 1: Thanks for
the response however AE
form is not updated with
the AE "slow to recover
from anesthesia" as
reported in safety database.
Please review and update
accordingly or clarify.
Jan-27-2021 14:32:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered AE UPDATED
Jan-21-2021 04:48:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021026240
slow to recover from
anesthesia(onset
date:02dec2020)was
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (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-2021-5683-0980054
Page 177 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
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.
Nov-02-2020 18:22:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/27/2020Initial Entry
Sep-10-2020 18:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
Sep-10-2020 18:42:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/10/2020Initial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4)
FDA-CBER-2021-5683-0980055
Page 178 of 178
***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: 1116 Site Name: (1116) MedPharmics, LLC
Subject No: 11161198 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:58
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-02-2020 18:22:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f1c\Final\Final On: 01-Apr-2021 05:10 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0980056