125742 S1 M5 CRF c4591001 1118 11181123

Document text

Page 1 of 152
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 version06 OCT 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798132
Page 2 of 152
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/22/2020
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798133
Page 3 of 152
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Demography
1.Subject ID [11181123]
2.Birth Date: /1953
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:
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798134
Page 4 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798135
Page 5 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798136
Page 6 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/22/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798137
Page 7 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TYPE 2 DIABETES]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2015
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GENERALIZED GOUT]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[STROKE]
Start Date: Feb/16/2016
Ongoing: NO
End Date:
Feb/16/2016
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798138
Page 8 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: UNK/UNK/2014
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MILD ASTHMA]
Start Date: UNK/UNK/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEPRESSION]
Start Date: UNK/UNK/2019
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DIABETIC NEUROPATHY]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798139
Page 9 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798140
Page 10 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Oct/22/2020
2.Weight: [242.0]
3.Unit: LB
4.Height: [65.0]
5.Unit: in
6.Body Mass Index: [40.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.5]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798141
Page 11 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/22/2020
2.Randomization Number: [271944]
3.Randomization Group: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798142
Page 12 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
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 [BPR7NW]
5.bSample ID [BRCJCZ]
5.cSample ID [BPR7MK]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798143
Page 13 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
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 [BPTP69]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798144
Page 14 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/22/2020 13:31
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798145
Page 15 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798146
Page 16 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798147
Page 17 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Vital Signs
1.Date: Nov/12/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798148
Page 18 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/12/2020
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 [BRCJDV]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798149
Page 19 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: Nov/12/2020 11:14
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798150
Page 20 of 152
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/10/2020
2.Erroneous Visit
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798151
Page 21 of 152
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/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 [BPSRVC]
5.bSample ID [BPR7PH]
5.cSample ID [BPR874]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798152
Page 22 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798153
Page 23 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798154
Page 24 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798155
Page 25 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798156
Page 26 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798157
Page 27 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798158
Page 28 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798159
Page 29 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798160
Page 30 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798161
Page 31 of 152
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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 [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798162
Page 32 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  IDIOPATHIC ACUTE PA
NCREATITIS Feb/6/2021
19:30 NO
End Date Time:
Feb/12/2021 16:20
 Repeating
Pages
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798163
Page 33 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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)[IDIOPATHIC ACUTE PANCREATITIS]
4.Start Date Time: Feb/6/2021 19:30
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/12/2021 16:20
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?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798164
Page 34 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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:
[IDIOPATHIC ACUTE PANCREATITIS]
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[2021156191]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798165
Page 35 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798166
Page 36 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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[ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798167
Page 37 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798168
Page 38 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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: //
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798169
Page 39 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798170
Page 40 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798171
Page 41 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798172
Page 42 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798173
Page 43 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798174
Page 44 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798175
Page 45 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798176
Page 46 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Unplanned Assessments
1.Assessments
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798177
Page 47 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798178
Page 48 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798179
Page 49 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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?
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798180
Page 50 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798181
Page 51 of 152
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798182
Page 52 of 152
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798183
Page 53 of 152
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/13/2021
2.Erroneous Visit
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798184
Page 54 of 152
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798185
Page 55 of 152
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798186
Page 56 of 152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/13/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798187
Page 57 of 152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798188
Page 58 of 152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798189
Page 59 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798190
Page 60 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/20/2021
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798191
Page 61 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798192
Page 62 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/20/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798193
Page 63 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/20/2021
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 [BPSS05]
5.bSample ID [BSHHBP]
5.cSample ID [BSHHC4]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798194
Page 64 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/20/2021
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 [BPSRZS]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798195
Page 65 of 152
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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/20/2021 13:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798196
Page 66 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/18/2021
2.Erroneous Visit
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798197
Page 67 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/18/2021
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 [BRCJG2]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798198
Page 68 of 152
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
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/18/2021 12:05
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
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798199
Page 69 of 152
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798200
Page 70 of 152
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798201
Page 71 of 152
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798202
Page 72 of 152
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798203
Page 73 of 152
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798204
Page 74 of 152
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798205
Page 75 of 152
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798206
Page 76 of 152
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/10/2020
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798207
Page 77 of 152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798208
Page 78 of 152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798209
Page 79 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormOct-22-2020 15:00:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798210
Page 80 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
ItemDate User Comment
FormJan-20-2021 14:29:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798211
Page 81 of 152
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-18-2021 07:40:32 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Feb-17-2021 14:29:19 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-12-2021 15:48:34 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 17:33:56 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798212
Page 82 of 152
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
By my dated signature below, I, , 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 Dec-11-2020 07:36:55 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Dec-10-2020 16:37:51 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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 Dec-10-2020 10:32:38 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-12-2020 14:22:57 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798213
Page 83 of 152
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-12-2020 13:20:47 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-02-2020 13:50:25 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798214
Page 84 of 152
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-22-2020 14:58:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
06 OCT 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-22-2020 14:58:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798215
Page 85 of 152
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-22-2020 14:58:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Oct/22/2020Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798216
Page 86 of 152
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-22-2020 14:55:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11181123Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-22-2020 14:59:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
/1953Changed
Information
Oct-22-2020 14:31:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1943Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-22-2020 14:59:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-22-2020 14:59:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-22-2020 14:59:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (6)
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798217
Page 87 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-22-2020 15:00:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798218
Page 88 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-22-2020 15:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-22-2020 15:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-22-2020 15:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798219
Page 89 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1.a
Date Location User Value Reason
Oct-22-2020 15:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical Histor
y Term:TYPE 2 DIA
BETES
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TYPE 2 DIABETESInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-22-2020 15:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-22-2020 15:01:39 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798220
Page 90 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00) Eastern
Time (US & Canada)YES
1.b
Date Location User Value Reason
Oct-22-2020 15:02:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:HYPERTEN
SION
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798221
Page 91 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.b Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:02:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:02:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERTENSIONInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-22-2020 15:02:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-22-2020 15:02:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Oct-22-2020 15:08:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:3
Medical Histo
ry Term:GENERALIZE
D GOUT
Start Date: UNK/UNK/20
00
Ongoing: YESNew Information
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798222
Page 92 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-22-2020 15:04:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:GOUT
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:04:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:08:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
GENERALIZED GOUTNew Information
Oct-22-2020 15:04:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
GOUTInitial Entry
1.c Start Date:
Date Location User Value Reason
Oct-22-2020 15:04:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Oct-22-2020 15:04:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798223
Page 93 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d
Date Location User Value Reason
Oct-22-2020 15:04:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:STROKE
Start Date: Feb/16/2016
Ongoing: NO
End Date:
Feb/16/2
016Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798224
Page 94 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.d Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:04:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:04:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STROKEInitial Entry
1.d Start Date:
Date Location User Value Reason
Oct-22-2020 15:04:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/16/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Oct-22-2020 15:04:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Feb/16/2016Initial Entry
1.e
Date Location User Value Reason
Oct-22-2020 15:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Hist
ory Term:HYPERCHOLE
STEROLEMIA
Start Date: UNK/UNK/2014
Ongoing: YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798225
Page 95 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.e Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERCHOLESTEROLEMIAInitial Entry
1.e Start Date:
Date Location User Value Reason
Oct-22-2020 15:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.e Ongoing:
Date Location User Value Reason
Oct-22-2020 15:05:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Oct-22-2020 15:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History
Term:MILD AST
HMA
Start Date: UNK/UNK/
2010
Ongoing: YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798226
Page 96 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.f Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:37:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Oct-23-2020 13:03:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered no planned or
current
corticosteroids - see
source
Oct-23-2020 12:57:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD Clin: The
subject presents at
screening with
ongoing asthma.
Please confirm that
participant is or is
not currently
receiving/plans to
receive systemic
corticosteroids with
the exception of
Inhaled Steroids
due to this
condition.
Oct-22-2020 15:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MILD ASTHMAInitial Entry
1.f Start Date:
Date Location User Value Reason
Oct-22-2020 15:05:31
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798227
Page 97 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
1.f Ongoing:
Date Location User Value Reason
Oct-22-2020 15:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Oct-22-2020 15:05:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:DEPRESSI
ON
Start Date: UNK/UNK/
2019
Ongoing: YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0798228
Page 98 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.g Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:05:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-23-2020 13:38:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Closed Response satisfies
query
Oct-23-2020 13:04:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered no suicidal
behavior-this is not
exclusionary thus
subject meets I/E
Oct-23-2020 12:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Svitlana
TonkovydQuery 1: Opened GPD CLIN: The
subject presents at
screening with
depression. Please
confirm subject
meets eligibility
per exclusion
criteria 1; else,
document
deviation on I/E
CRF and report
deviation as
applicable. Thank
you
Oct-22-2020 15:05:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DEPRESSIONInitial Entry
1.g Start Date:
Date Location User Value Reason
Oct-22-2020 15:05:52
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798229
Page 99 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
1.g Ongoing:
Date Location User Value Reason
Oct-22-2020 15:05:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Oct-22-2020 15:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Hist
ory Term:DIABETIC NE
UROPATHY
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0798230
Page 100 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
1.h Line/MH Number:
Date Location User Value Reason
Oct-22-2020 15:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-22-2020 15:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIABETIC NEUROPATHYInitial Entry
1.h Start Date:
Date Location User Value Reason
Oct-22-2020 15:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Oct-22-2020 15:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798231
Page 101 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-22-2020 15:06:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to be
HIV POSITIVEInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798232
Page 102 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Oct-22-2020 15:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-22-2020 15:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
242.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-22-2020 15:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-22-2020 15:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
65.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-22-2020 15:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798233
Page 103 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-22-2020 15:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
40.3Initial Entry
7.a
Date Location User Value Reason
Oct-22-2020 15:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 36.5
Temperature Uni
t:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-22-2020 15:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-22-2020 15:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.5Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-22-2020 15:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798234
Page 104 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-22-2020 15:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798235
Page 105 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-22-2020 15:08:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-22-2020 15:08:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
271944Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798236
Page 106 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 15:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 15:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 16:50:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 15:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-22-2020 15:09:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798237
Page 107 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-22-2020 16:50:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR7NWInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 16:50:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPR7NWInitial Entry
5.b
Date Location User Value Reason
Oct-22-2020 16:51:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRCJCZInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-22-2020 16:51:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRCJCZInitial Entry
5.c
Date Location User Value Reason
Oct-22-2020 16:51:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR7MKInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-22-2020 16:51:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPR7MKInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (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-2021-5683-0798238
Page 108 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-22-2020 15:09:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-22-2020 15:09:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-22-2020 16:51:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-22-2020 15:09:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-22-2020 15:09:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/22/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798239
Page 109 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-22-2020 16:51:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTP69Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-22-2020 16:51:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPTP69Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798240
Page 110 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-22-2020 15:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-22-2020 15:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-22-2020 15:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-22-2020 15:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020 13:31Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-22-2020 15:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798241
Page 111 of 152
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Oct-22-2020 15:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Oct-22-2020 15:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-22-2020 15:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-22-2020 15:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798242
Page 112 of 152
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-22-2020 15:10:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798243
Page 113 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-12-2020 13:20:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798244
Page 114 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date:
Date Location User Value Reason
Nov-12-2020 13:21:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
2.a
Date Location User Value Reason
Nov-12-2020 13:21:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 97.3
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-12-2020 13:21:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-12-2020 13:21:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.3Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-12-2020 13:21:18 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798245
Page 115 of 152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
(UTC-05:00) Eastern
Time (US & Canada)F
2.a Temperature Location:
Date Location User Value Reason
Nov-12-2020 13:21:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798246
Page 116 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-12-2020 13:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-12-2020 13:21:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/12/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798247
Page 117 of 152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-12-2020 13:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRCJDVInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-12-2020 13:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRCJDVInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798248
Page 118 of 152
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-12-2020 13:21:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-12-2020 13:21:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-12-2020 13:21:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-12-2020 13:21:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020 11:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-12-2020 13:21:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798249
Page 119 of 152
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Nov-12-2020 13:21:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Nov-12-2020 13:21:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-12-2020 13:21:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-12-2020 13:21:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798250
Page 120 of 152
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-14-2020 01:38:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Dec-11-2020 07:37:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered updated per query
Dec-11-2020 06:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
treatment period is
defined as 1st
vaccination visit
through the
1-month post
vaccination visit
after the 2nd
vaccination.
Please complete
treatment
disposition CRF
and update date of
EOT to match date
of visit at visit 3.
Dec-10-2020 10:32:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/10/2020Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798251
Page 121 of 152
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-10-2020 10:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-10-2020 10:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-10-2020 13:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-10-2020 10:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-10-2020 10:32:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/10/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798252
Page 122 of 152
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Dec-10-2020 13:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPSRVCInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-10-2020 13:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPSRVCInitial Entry
5.b
Date Location User Value Reason
Dec-10-2020 13:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR7PHInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-10-2020 13:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPR7PHInitial Entry
5.c
Date Location User Value Reason
Dec-10-2020 13:47:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPR874Initial Entry
5.c Sample ID
Date Location User Value Reason
Dec-10-2020 13:47:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPR874Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (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-2021-5683-0798253
Page 123 of 152
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
Date Location User Value Reason
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798254
Page 124 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Category:
Date Location User Value Reason
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-25-2021 10:33:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Feb-19-2021 08:26:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered updated SAE
report faxed to
DSU
Feb-17-2021 06:50:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Medical Monitor_
Pls provide further
details on clinical
presentation,
workup performed
and treatment
received in a FU
form so this
information is
added to the safety
report. Thanks.
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IDIOPATHIC ACUTE PANC
REATITISInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0798255
Page 125 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
4. Start Date Time:
Date Location User Value Reason
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/6/2021 19:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-18-2021 12:32:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/12/2021 16:20New Information
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-15-2021 20:03:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-12-2021 15:50:45
(UTC-05:00) EasternACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798256
Page 126 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada)
Feb-12-2021 15:50:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event requir
e or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
NONew Information
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least
one seriousness
criteria is missing.
Please review and
update as
appropriate.
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798257
Page 127 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
IDIOPATHIC
ACUTE
PANCREATITIS:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event requir
e or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?
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
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798258
Page 128 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
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:
IDIOPATHIC ACUTE PA
NCREATITISInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (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-2021-5683-0798259
Page 129 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Date Location User Value Reason
Feb-24-2021
16:00:45
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed SDB updated
Feb-24-2021
01:31:17
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued
:OpenedSA RECON: Per latest SAE listing
outcome still recorded as
RECOVERING/RESOLVING.
Please confirm if follow up AEM
form was sent to update outcome to
recovered/resolved.
Feb-21-2021
08:27:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued
:CandidatePending SDB update
Feb-19-2021
08:25:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dupdated SAE follow up report and
faxed to DSU
Feb-18-2021
12:58:30
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Reissued
:OpenedSAE
RECON1:AER#2021156191,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as
RECOVERED/RESOLVED on AE
CRF. Please confirm correct outcome.
If safety update is required, please
submit a follow-up form.
Feb-18-2021
12:32:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-18-2021
12:32:26
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
RECOVERED/R
ESOLVEDNew Information
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (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-2021-5683-0798260
Page 130 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Eastern Time (US
& Canada)
Feb-18-2021
12:32:08
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE IDIOPATHIC ACUTE
PANCREATITIS: Response to "What
was the outcome of this adverse
event?" is 'Recovering/Resolving' but
AE End Date/Time is present.
Feb-18-2021
07:40:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dupdated per query
Feb-18-2021
07:40:32
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/R
ESOLVINGupdated per query
Feb-18-2021
02:05:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021156191,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as NOT
RECOVERED/NOT RESOLVED on
AE CRF. Please confirm correct
outcome. If safety update is required,
please submit a follow-up form.
Feb-12-2021
15:48:34
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVER
ED/NOT RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-12-2021 15:48:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798261
Page 131 of 152
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-15-2021 20:03:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021156191Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798262
Page 132 of 152
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Dec-11-2020 07:36:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-11-2020 07:36:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-11-2020 07:36:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798263
Page 133 of 152
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-14-2021 16:55:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798264
Page 134 of 152
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-15-2021 16:22:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-14-2021 23:54:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-14-2021 16:56:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-14-2021 16:56:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to retur
n for Vaccination 3
Participant is:
eligible per local/national
recommendations and con
firmed to have received o
nly placebo at Vaccinatio
n 1/2Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0798265
Page 135 of 152
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-15-2021 16:22:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/13/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-15-2021 16:22:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798266
Page 136 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-20-2021 14:29:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798267
Page 137 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-20-2021 14:29:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/20/2021Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798268
Page 138 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-20-2021 14:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-20-2021 14:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-20-2021 14:29:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798269
Page 139 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-20-2021 14:31:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-20-2021 14:31:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-20-2021 14:39:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-20-2021 14:31:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/20/2021New Information
Jan-20-2021 14:31:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-20-2021 14:31:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798270
Page 140 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.a
Date Location User Value Reason
Jan-20-2021 14:39:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPSS05Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-20-2021 14:39:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPSS05Initial Entry
5.b
Date Location User Value Reason
Jan-20-2021 14:40:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSHHBPInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-20-2021 14:40:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSHHBPInitial Entry
5.c
Date Location User Value Reason
Jan-20-2021 14:40:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSHHC4Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798271
Page 141 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
5.c Sample ID
Date Location User Value Reason
Jan-20-2021 14:40:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSHHC4Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798272
Page 142 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-20-2021 14:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-20-2021 14:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-20-2021 14:41:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-20-2021 14:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-20-2021 14:31:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/20/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798273
Page 143 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jan-20-2021 14:41:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPSRZSInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-20-2021 14:41:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPSRZSInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798274
Page 144 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-20-2021 14:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-20-2021 14:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-20-2021 14:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-20-2021 14:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021 13:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-20-2021 14:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798275
Page 145 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Jan-20-2021 14:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-20-2021 14:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-20-2021 14:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-20-2021 14:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-20-2021 14:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-20-2021 14:32:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798276
Page 146 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Date of Visit
Date Location User ValueReason
Feb-23-2021
02:02:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedClosed per
SITE response,
added to PD
tracker for
Clinical
Review
Feb-22-2021
10:32:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dSubject was
hospitalized
and unable to
come in during
window. Date
is correct.
Feb-22-2021
01:37:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPDQ: Date of
visit
V102_VAX4 is
out of window
for 6 days from
V101_VAX3
Dose Date.
Please verify
and update.
Else, confirm
in query
response
appropriately.
Feb-18-2021
12:45:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Feb/1
8/202
1Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0798277
Page 147 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-18-2021 12:46:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-18-2021 12:46:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-19-2021 12:18:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-19-2021 06:24:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-18-2021 12:46:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-18-2021 12:46:11
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798278
Page 148 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Time (US & Canada) Date of Collection:
Feb/18/2021
5.a
Date Location User Value Reason
Feb-19-2021 12:18:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRCJG2Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-19-2021 12:18:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRCJG2Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798279
Page 149 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Feb-18-2021 12:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-18-2021 12:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-18-2021 12:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-18-2021 12:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/18/2021 12:05Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-18-2021 12:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798280
Page 150 of 152
***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: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Feb-18-2021 12:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Feb-18-2021 12:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-18-2021 12:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-18-2021 12:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-18-2021 12:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-18-2021 12:46:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0798281
Page 151 of 152
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Subject Status
Date Location User Value Reason
Dec-11-2020 07:36:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-22-2020 15:08:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Oct-22-2020 15:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Dec-11-2020 07:36:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Dec/10/2020Initial Entry
Oct-22-2020 15:08:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
Oct-22-2020 15:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/22/2020Initial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4)
FDA-CBER-2021-5683-0798282
Page 152 of 152
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1118 Site Name: (1118) United Medical Associates
Subject No: 11181123 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:09
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-02-2020 11:53:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae40c6\Final\Final On: 01-Apr-2021 05:43 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0798283