125742 S1 M5 CRF c4591001 1161 11611016

Document text

Page 1 of 256
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842086
Page 2 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/1/2020
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842087
Page 3 of 256
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Demography
1.Subject ID [11611016]
2.Birth Date: /2000
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842088
Page 4 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/1/2020
2.Erroneous Visit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842089
Page 5 of 256
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 years, inclusive, at randomization
(dependent upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for
inclusion in the study
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use
only)IN04A00
Exclusion Criteria
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842090
Page 6 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency,
as determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX08A00
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842091
Page 7 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2 fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would,
in the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX10A00
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before
study intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX14A01
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842092
Page 8 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior
to study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX16A01
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use
only)EX21A01
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842093
Page 9 of 256
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/1/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842094
Page 10 of 256
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[seasonal allergies]
Start Date: UNK/UNK/2013
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[iron deficiency]
Start Date: UNK/UNK/2013
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[heartburn]
Start Date: Feb/UNK/2020
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[mild depression]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842095
Page 11 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lumbar pain]
Start Date: UNK/UNK/2016
Ongoing: YES
1.fLine/MH Number: [ ]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ ]
Start Date: //
Ongoing:
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842096
Page 12 of 256
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Aug/1/2020
2.Weight: [74.8]
3.Unit: kg
4.Height: [160.0]
5.Unit: cm
6.Body Mass Index: [29.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842097
Page 13 of 256
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842098
Page 14 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/1/2020
2.Randomization Number: [41384]
3.Randomization Group: [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842099
Page 15 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/1/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3D3G]
5.bSample ID [BP3D3H]
5.cSample ID [BP3D3J]
5.dSample ID [BP3D3K]
5.eSample ID [BP3D3L]
5.fSample ID [BPLL5G]
5.gSample ID [BPLL5H]
5.hSample ID [BPLL5J]
5.iSample ID [BPLL5K]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842100
Page 16 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/1/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3D8D]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842101
Page 17 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: Aug/1/2020 16:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842102
Page 18 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842103
Page 19 of 256
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842104
Page 20 of 256
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842105
Page 21 of 256
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842106
Page 22 of 256
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vital Signs
1.Date: Nov/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842107
Page 23 of 256
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Nov/19/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842108
Page 24 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Nov/19/2020
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 [BP3DBV]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842109
Page 25 of 256
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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/19/2020 10:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842110
Page 26 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842111
Page 27 of 256
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842112
Page 28 of 256
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842113
Page 29 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/17/2020
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 [BP3DCZ]
5.bSample ID [BPLLC9]
5.cSample ID [BPLLCB]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842114
Page 30 of 256
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842115
Page 31 of 256
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842116
Page 32 of 256
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842117
Page 33 of 256
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842118
Page 34 of 256
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842119
Page 35 of 256
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842120
Page 36 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/2/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842121
Page 37 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/2/2020
2.Date of First Symptom Started: Nov/29/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/7/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? YES
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842122
Page 38 of 256
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [headache]
5.bSymptoms - Other Text: [Nasal congestion]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842123
Page 39 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Dec/2/202
0 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842124
Page 40 of 256
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Dec/2/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842125
Page 41 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[waiting to receive self swab]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW79132]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842126
Page 42 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[subject will collect self swab]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842127
Page 43 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842128
Page 44 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Treatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842129
Page 45 of 256
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842130
Page 46 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[covid-19]
Date of Diagnosis:
Dec/2/2020
3.Toxicity Grade: 2
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842131
Page 47 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842132
Page 48 of 256
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842133
Page 49 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842134
Page 50 of 256
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842135
Page 51 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842136
Page 52 of 256
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842137
Page 53 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842138
Page 54 of 256
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842139
Page 55 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842140
Page 56 of 256
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842141
Page 57 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842142
Page 58 of 256
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842143
Page 59 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842144
Page 60 of 256
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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.Start Date: //
6.Ongoing?
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842145
Page 61 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842146
Page 62 of 256
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842147
Page 63 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/30/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842148
Page 64 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/30/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/30/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP3DD7]
5.bSample ID [BPLLCV]
5.cSample ID [BPLLCW]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842149
Page 65 of 256
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/25/2021Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842150
Page 66 of 256
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/25/2021Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Unplanned Assessments
1.Assessments Not Applicable Comments
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842151
Page 67 of 256
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/25/2021Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Contact Outcome
1.Contact Type: Not Applicable Comments
2.Was contact made? Not Applicable Comments
3.Comments: Not Applicable
[ ]Comments
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842152
Page 68 of 256
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/25/2021Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Temperature: Not Applicable
[ ]Comments
Unit: Not Applicable Comments
Temperature Location: Not Applicable Comments
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842153
Page 69 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/17/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842154
Page 70 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842155
Page 71 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842156
Page 72 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842157
Page 73 of 256
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Exposure during Pre
gnancy Jan/17/2021 UNK
:UNK YES  Repeating
Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842158
Page 74 of 256
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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)[Exposure during Pregnancy]
4.Start Date Time: Jan/17/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[relations]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842159
Page 75 of 256
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:UNKNOWN
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842160
Page 76 of 256
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842161
Page 77 of 256
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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[ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842162
Page 78 of 256
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842163
Page 79 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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: //
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842164
Page 80 of 256
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842165
Page 81 of 256
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842166
Page 82 of 256
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842167
Page 83 of 256
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842168
Page 84 of 256
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842169
Page 85 of 256
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842170
Page 86 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842171
Page 87 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842172
Page 88 of 256
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842173
Page 89 of 256
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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?
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842174
Page 90 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842175
Page 91 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842176
Page 92 of 256
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842177
Page 93 of 256
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842178
Page 94 of 256
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842179
Page 95 of 256
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842180
Page 96 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/22/2021
2.Erroneous Visit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842181
Page 97 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
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 other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842182
Page 98 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842183
Page 99 of 256
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842184
Page 100 of 256
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842185
Page 101 of 256
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842186
Page 102 of 256
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Informed Consent - Further Vaccination
1.Consent Was:
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842187
Page 103 of 256
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not Met
Exclusion Criteria Met
2.Description of Exclusion
Criterion Met
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842188
Page 104 of 256
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Not Started
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842189
Page 105 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/17/2020
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842190
Page 106 of 256
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842191
Page 107 of 256
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Darrell
Herrington Approved Mar-08-2021 12:03:13 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DarrellHerrington, 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.
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842192
Page 108 of 256
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/25/2021Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-05-2021 16:25:53 (UTC-06:00) Central
Time (US & Canada)not applicable
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842193
Page 109 of 256
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/25/2021Form: UNPLANNED VISIT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-01-2021 15:37:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842194
Page 110 of 256
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: UNPLANNED VISIT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-01-2021 15:37:12 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842195
Page 111 of 256
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/25/2021Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-01-2021 15:36:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842196
Page 112 of 256
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-01-2021 15:36:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842197
Page 113 of 256
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2Mar-01-2021 15:36:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842198
Page 114 of 256
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
3Mar-01-2021 15:36:28 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842199
Page 115 of 256
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Feb/25/2021Form: VITAL SIGNS - TEMP - Comments
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
FormMar-01-2021 15:37:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormFeb-25-2021 17:11:09 (UTC-06:00) Central
Time (US & Canada)
FormFeb-25-2021 17:09:18 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842200
Page 116 of 256
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
1Mar-01-2021 15:37:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
1Feb-25-2021 17:11:09 (UTC-06:00) Central
Time (US & Canada)
1Feb-25-2021 17:09:18 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842201
Page 117 of 256
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aMar-01-2021 15:37:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
2.aFeb-25-2021 17:11:09 (UTC-06:00) Central
Time (US & Canada)
2.aFeb-25-2021 17:09:18 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842202
Page 118 of 256
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aMar-01-2021 15:37:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
2.aFeb-25-2021 17:11:09 (UTC-06:00) Central
Time (US & Canada)
2.aFeb-25-2021 17:09:18 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842203
Page 119 of 256
***Confidential***
Header Text: c4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 20-Feb-2021 02:16 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
ItemDate User Comment
2.aMar-01-2021 15:37:41 (UTC-06:00) Central
Time (US & Canada)Not Applicable
2.aFeb-25-2021 17:11:09 (UTC-06:00) Central
Time (US & Canada)
2.aFeb-25-2021 17:09:18 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842204
Page 120 of 256
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Darrell
Herrington Approved Mar-08-2021 12:03:13 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DarrellHerrington, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Mar-03-2021 16:42:21 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Darrell
Herrington Approved Mar-02-2021 14:05:58 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DarrellHerrington, 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-22-2021 13:57:59 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842205
Page 121 of 256
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Darrell
Herrington Approved Jan-05-2021 08:33:15 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DarrellHerrington, 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-04-2020 12:07:24 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Darrell
Herrington Approved Dec-02-2020 17:19:20 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DarrellHerrington, 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-02-2020 15:41:07 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Darrell
Herrington Approved Dec-01-2020 16:02:24 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842206
Page 122 of 256
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Affidavit:
By my dated signature below, I, DarrellHerrington, 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-19-2020 16:24:02 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Darrell
Herrington Approved Sep-11-2020 17:34:16 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DarrellHerrington, 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.
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842207
Page 123 of 256
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-02-2020 15:17:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
30 JUN 2020Transcription Error
Aug-02-2020 15:08:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-02-2020 15:08:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842208
Page 124 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-02-2020 15:08:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/1/2020Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842209
Page 125 of 256
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-02-2020 15:07:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11611016Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-02-2020 15:07:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/2000Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-02-2020 15:09:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-02-2020 15:09:00
(UTC-06:00) Central
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
Aug-02-2020 15:09:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842210
Page 126 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-02-2020 15:10:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/1/2020Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842211
Page 127 of 256
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion D
escrip
tion:Male or female participa
nts between the ages of 1
8 and 55 years, inclusive,
65 and 85 years, inclusiv
e, or 18 and 85 years, inc
lusive, at randomization (
dependent upon study sta
ge)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Male or female participants betw
een the ages of 18 and 55 years, i
nclusive, 65 and 85 years, inclusiInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842212
Page 128 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
ve, or 18 and 85 years, inclusive,
at randomization (dependent upo
n study stage)
1.a Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criter
ion De
scripti
on:Participants who are will
ing and able to comply
with all scheduled visits,
vaccination plan, laborat
ory tests, lifestyle consid
erations, and other study
procedures
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842213
Page 129 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b Inclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participants who are willing and
able to comply with all scheduled
visits, vaccination plan, laborator
y tests, lifestyle considerations, a
nd other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inclus
ion Nu
mber:3Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842214
Page 130 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Criter
ion De
scripti
on:Healthy participants who
are determined by medic
al history, physical exam
ination, and clinical judg
ment of the investigator t
o be eligible for inclusio
n in the study
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842215
Page 131 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.c Inclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Healthy participants who are dete
rmined by medical history, physic
al examination, and clinical judg
ment of the investigator to be elig
ible for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842216
Page 132 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Criteri
on Des
criptio
n:Capable of giving perso
nal signed informed con
sent, which includes co
mpliance with the requir
ements and restrictions l
isted in the ICD and in t
his protocol
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN04A00
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842217
Page 133 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.d Inclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Capable of giving personal signe
d informed consent, which includ
es compliance with the requireme
nts and restrictions listed in the I
CD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclu
sion N
umbe
r:1Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842218
Page 134 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Criter
ion De
scripti
on:Other medical or psychia
tric condition incl. recent
(within past year) or acti
ve suicidal ideation/beha
vior/lab abnormality that
may increase the risk of
study participation
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Other medical or psychiatric cond
ition incl. recent (within past year
) or active suicidal ideation/behav
ior/lab abnormality that may incr
ease the risk of study participatio
nInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842219
Page 135 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:2
Criterio
n Descri
ption:Known infection with
human immunodeficie
ncy virus (HIV), hepati
tis C virus (HCV), or h
epatitis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842220
Page 136 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.b Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Known infection with human im
munodeficiency virus (HIV), hep
atitis C virus (HCV), or hepatitis
B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842221
Page 137 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Criteri
on Des
criptio
n:History of severe advers
e reaction associated wit
h a vaccine and/or sever
e allergic reaction (eg, a
naphylaxis) to any comp
onent of the study interv
ention(s)
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842222
Page 138 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.c Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
History of severe adverse reactio
n associated with a vaccine and/o
r severe allergic reaction (eg, ana
phylaxis) to any component of th
e study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion N
umber:4
Criterion D
escription:Receipt of medicat
ions intended to pr
event COVID-19Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842223
Page 139 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Criterion m
et?:NO
Criterion ID
: (For Pfizer
use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of medications intended t
o prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:8Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842224
Page 140 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodefici
ency, as determined by
history and/or laborator
y/physical examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX08A00
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842225
Page 141 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.e Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Immunocompromised individuals
with known or suspected immuno
deficiency, as determined by hist
ory and/or laboratory/physical ex
aminationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842226
Page 142 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Criteri
on Des
criptio
n:Bleeding diathesis or co
ndition associated with
prolonged bleeding that
would, in the opinion of
the investigator, contrain
dicate intramuscular inje
ction
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX10A00
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842227
Page 143 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.f Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition as
sociated with prolonged bleeding
that would, in the opinion of the i
nvestigator, contraindicate intram
uscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:11
Criterion Des
cription:Women who are
pregnant or brea
stfeedingInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842228
Page 144 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Women who are pregnant or brea
stfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion N
umber:12Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842229
Page 145 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Criterion De
scription:Previous vaccinat
ion with any coro
navirus vaccine
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Previous vaccination with any cor
onavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-02-2020 15:17:47 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842230
Page 146 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)Exclusio
n Numb
er:13
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive th
erapy, such as cytotoxi
c agents or systemic c
orticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX13A01
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842231
Page 147 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.i Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Subjects who receive immunosup
pressive therapy, such as cytotoxi
c agents or systemic corticosteroi
dsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:15Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842232
Page 148 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglob
ulin, from 60 days befor
e study intervention adm
inistration or planned re
ceipt throughout the stu
dy
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX14A01
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4)
FDA-CBER-2021-5683-0842233
Page 149 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.j Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products
or immunoglobulin, from 60 days
before study intervention adminis
tration or planned receipt through
out the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842234
Page 150 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
2.k
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Desc
ription:Participation in other st
udies involving study i
ntervention within 28 d
ays prior to study entry
and/or during study par
ticipation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX15A01Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842235
Page 151 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.k Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participation in other studies inv
olving study intervention within
28 days prior to study entry and/
or during study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:17Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842236
Page 152 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Criterio
n Descri
ption:Previous participation
in other studies involv
ing study intervention
containing lipid nano
particles
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Previous participation in other st
udies involving study interventio
n containing lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842237
Page 153 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.m
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclu
sion N
umbe
r:22
Criter
ion D
escrip
tion:Investigator site staff or
Pfizer employees directl
y involved in the conduc
t of the study, site staff o
therwise supervised by t
he investigator, and their
respective family memb
ers
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842238
Page 154 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.m Exclusion Number:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer e
mployees directly involved in the
conduct of the study, site staff ot
herwise supervised by the investi
gator, and their respective family
membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-02-2020 15:17:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842239
Page 155 of 256
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-02-2020 15:14:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-02-2020 15:14:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-02-2020 15:14:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842240
Page 156 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1.a
Date Location User Value Reason
Aug-02-2020 15:21:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:seasonal aller
gies
Start Date: UNK/UNK/2
013
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-02-2020 15:21:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-02-2020 15:21:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
seasonal allergiesInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-02-2020 15:21:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-02-2020 15:21:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842241
Page 157 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
1.b
Date Location User Value Reason
Aug-02-2020 15:22:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:iron deficienc
y
Start Date: UNK/UNK/2
013
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-02-2020 15:22:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-02-2020 15:22:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
iron deficiencyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-02-2020 15:22:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-02-2020 15:22:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842242
Page 158 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Aug-02-2020 15:23:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:heartburn
Start Date: Feb/UNK/20
20
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-02-2020 15:23:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-02-2020 15:23:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
heartburnInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-02-2020 15:23:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/UNK/2020Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-02-2020 15:23:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-02-2020 15:25:21 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842243
Page 159 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Number
:4
Medical History T
erm:mild depressi
on
Start Date: UNK/UNK/2
019
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-02-2020 15:25:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-02-2020 15:25:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
mild depressionInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-02-2020 15:25:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-02-2020 15:25:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-02-2020 15:25:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:5Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842244
Page 160 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Medical History T
erm:lumbar pain
Start Date: UNK/UNK/2
016
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Aug-02-2020 15:25:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-02-2020 15:25:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
lumbar painInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-02-2020 15:25:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-02-2020 15:25:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842245
Page 161 of 256
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Aug-02-2020 15:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/1/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-02-2020 15:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
74.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-02-2020 15:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-02-2020 15:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
160.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-02-2020 15:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-02-2020 15:31:20
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.2Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842246
Page 162 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-02-2020 15:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Locat
ion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-02-2020 15:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-02-2020 15:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-02-2020 15:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-02-2020 15:31:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842247
Page 163 of 256
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-02-2020 15:32:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-02-2020 15:32:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-02-2020 15:32:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-02-2020 15:32:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-02-2020 15:32:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842248
Page 164 of 256
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug-02-2020 15:32:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-02-2020 15:32:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-02-2020 15:32:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-02-2020 15:32:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842249
Page 165 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-02-2020 15:33:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/1/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-02-2020 15:33:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
41384Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842250
Page 166 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-02-2020 15:33:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-02-2020 15:33:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020 15:14:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-04-2020 05:07:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-02-2020 15:33:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-02-2020 15:33:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842251
Page 167 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug/1/2020
5.a
Date Location User Value Reason
Aug-10-2020 15:14:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3D3GInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-10-2020 15:14:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3D3GInitial Entry
5.b
Date Location User Value Reason
Aug-10-2020 15:14:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3D3HInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-10-2020 15:14:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3D3HInitial Entry
5.c
Date Location User Value Reason
Aug-10-2020 15:28:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3D3JInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842252
Page 168 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.c Sample ID
Date Location User Value Reason
Aug-10-2020 15:28:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3D3JInitial Entry
5.d
Date Location User Value Reason
Aug-10-2020 15:28:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3D3KInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-10-2020 15:28:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3D3KInitial Entry
5.e
Date Location User Value Reason
Aug-10-2020 15:29:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3D3LInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-10-2020 15:29:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3D3LInitial Entry
5.f
Date Location User Value Reason
Aug-10-2020 15:31:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLL5GInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842253
Page 169 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.f Sample ID
Date Location User Value Reason
Aug-10-2020 15:31:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLL5GInitial Entry
5.g
Date Location User Value Reason
Aug-10-2020 15:31:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLL5HInitial Entry
5.g Sample ID
Date Location User Value Reason
Aug-10-2020 15:31:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLL5HInitial Entry
5.h
Date Location User Value Reason
Aug-10-2020 15:31:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLL5JInitial Entry
5.h Sample ID
Date Location User Value Reason
Aug-10-2020 15:31:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLL5JInitial Entry
5.i
Date Location User Value Reason
Aug-10-2020 15:31:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLL5KInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842254
Page 170 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.i Sample ID
Date Location User Value Reason
Aug-10-2020 15:31:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLL5KInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842255
Page 171 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-02-2020 15:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-02-2020 15:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-10-2020 15:32:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-04-2020 05:07:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-02-2020 15:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-02-2020 15:33:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842256
Page 172 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Aug/1/2020
5.a
Date Location User Value Reason
Aug-10-2020 15:32:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3D8DInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-10-2020 15:32:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3D8DInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842257
Page 173 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-02-2020 15:34:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-02-2020 15:34:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-02-2020 15:34:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-02-2020 15:34:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/1/2020 16:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-02-2020 15:34:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-02-2020 15:34:03
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842258
Page 174 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-02-2020 15:34:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-02-2020 15:34:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-02-2020 15:34:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842259
Page 175 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-11-2020 05:24:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-10-2020 15:13:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Aug-10-2020 15:13:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED F
OR THIS SUBJECTTranscription Error
Aug-07-2020 04:46:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM Query: Patient
is expected to be
included in the
Reactogenicity
subset. Please
review and update
as appropriate
Aug-02-2020 15:34:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY
E-DIARY NOT COLLECT
ED FOR THIS SUBJECTInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842260
Page 176 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-22-2020 23:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed per SITE
response, added to
PD tracker for
Clinical review
Nov-20-2020 17:36:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered visit 2 is oow due to
study on pause per
sponsor
Nov-20-2020 01:54:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: DOV at this
visit is out of
window (87 day)
from DOV (01/Aug
/2020) at
V1D1VX1L. Please
either update DOV
or confirm whether
visit is out of
window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Nov-19-2020 16:24:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842261
Page 177 of 256
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842262
Page 178 of 256
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
GU
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NO
2.b Symptom:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842263
Page 179 of 256
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.c Symptom:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842264
Page 180 of 256
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842265
Page 181 of 256
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.f Symptom:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842266
Page 182 of 256
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.h
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or syste
mic symptoms prese
nt on the last day the
Subject Diary was co
mpleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842267
Page 183 of 256
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842268
Page 184 of 256
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020 16:24:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842269
Page 185 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date:
Date Location User Value Reason
Nov-19-2020 16:27:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020Initial Entry
2.a
Date Location User Value Reason
Nov-19-2020 16:27:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.3
Temperature Unit: F
Temperature Locat
ion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-19-2020 16:27:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-19-2020 16:27:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-19-2020 16:27:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842270
Page 186 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Nov-19-2020 16:27:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842271
Page 187 of 256
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-19-2020 16:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-19-2020 16:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-19-2020 16:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-19-2020 16:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-19-2020 16:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842272
Page 188 of 256
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Nov-19-2020 16:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-19-2020 16:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-19-2020 16:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-19-2020 16:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842273
Page 189 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-19-2020 16:28:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-19-2020 16:28:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-23-2020 11:03:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-20-2020 04:10:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-19-2020 16:28:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-19-2020 16:28:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/19/2020Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842274
Page 190 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a
Date Location User Value Reason
Nov-23-2020 11:03:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3DBVInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-23-2020 11:03:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3DBVInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842275
Page 191 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-19-2020 16:29:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-19-2020 16:29:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-19-2020 16:29:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-19-2020 16:29:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/19/2020 10:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-19-2020 16:29:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-19-2020 16:29:40
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842276
Page 192 of 256
***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, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Time (US & Canada)
7. Route:
Date Location User Value Reason
Nov-19-2020 16:29:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-19-2020 16:29:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-19-2020 16:29:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842277
Page 193 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-17-2020 12:49:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020Initial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842278
Page 194 of 256
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842279
Page 195 of 256
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
GU
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary wa
s completed?:NO
2.b Symptom:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842280
Page 196 of 256
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.c Symptom:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842281
Page 197 of 256
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842282
Page 198 of 256
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.f Symptom:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842283
Page 199 of 256
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
2.h
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842284
Page 200 of 256
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842285
Page 201 of 256
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020 12:49:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842286
Page 202 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020 12:50:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020 12:50:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020 15:53:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-17-2020 12:50:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-17-2020 12:50:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/17/2020Initial Entry
5.a
Date Location User Value Reason
Dec-17-2020 15:53:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP3DCZInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842287
Page 203 of 256
***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: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
5.a Sample ID
Date Location User Value Reason
Dec-17-2020 15:53:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP3DCZInitial Entry
5.b
Date Location User Value Reason
Dec-17-2020 15:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLLC9Initial Entry
5.b Sample ID
Date Location User Value Reason
Dec-17-2020 15:53:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLLC9Initial Entry
5.c
Date Location User Value Reason
Dec-17-2020 15:53:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLLCBInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-17-2020 15:53:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLLCBInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (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-2021-5683-0842288
Page 204 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-09-2020 00:42:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Dec-08-2020 10:42:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered updated illness
form
Dec-08-2020 05:40:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened DM: Kindly review
and complete
‘Illness Details
form' at this visit.
Thank you.
Dec-04-2020 16:17:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-03-2020 05:30:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Dec-02-2020 15:42:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Dec-02-2020 15:41:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0842289
Page 205 of 256
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1161 Site Name: (1161) Benchmark Research - San Angelo
Subject No: 11611016 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:23
Dec-02-2020 15:41:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Dec-02-2020 15:41:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/2/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-02-2020 15:41:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d53\Final\Final On: 01-Apr-2021 04:31 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0842290
Page 206 of 256
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Dec/02/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, F
…[truncated]