Institution Name, Identifier
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Informed Consent Date in time
Item
Informed Consent date
date
C2985782 (UMLS CUI [1])
Person Initials, First Name
Item
Subject initials - First Name
text
C2986440 (UMLS CUI [1,1])
C1443235 (UMLS CUI [1,2])
Person Initials, Last Name
Item
Subject initials - Family Name
text
C2986440 (UMLS CUI [1,1])
C1301584 (UMLS CUI [1,2])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Item
Race
text
C0034510 (UMLS CUI [1])
CL Item
Other, please specify (4)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Eligibility Determination
Item
Is the subject eligible for the study, according to the criteria listed hereby?
boolean
C0013893 (UMLS CUI [1])
Disease, Symptoms
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Item
Organ
text
C0678852 (UMLS CUI [1])
CL Item
Ears-nose-throat (3)
CL Item
Cardiovascular (4)
CL Item
Gastrointestinal (6)
CL Item
Musculoskeletal (7)
CL Item
Genitourinary (9)
CL Item
Other (specify) (13)
Disease, Symptoms, Past
Item
Past
boolean
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1444637 (UMLS CUI [1,3])
Disease, Symptoms, Current
Item
Current
boolean
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Disease, Symptoms, Diagnosis
Item
Diagnosis
text
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Vaccination, Before, Body Temperature
Item
Pre-Vaccination Temperature
float
C0042196 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
Item
Pre-Vaccination Temperature - Route
text
C0042196 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
C0449687 (UMLS CUI [1,4])
Code List
Pre-Vaccination Temperature - Route
Collection of blood specimen for laboratory procedure
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Item
Has a blood sample been taken for RF1-like antibodies testing (only for 50 subjects per group)?
text
C0005834 (UMLS CUI [1,1])
C0003241 (UMLS CUI [1,2])
Code List
Has a blood sample been taken for RF1-like antibodies testing (only for 50 subjects per group)?
Item
Has a urine sample (Pregnancy test - HCG) been taken?
text
C0200354 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
Code List
Has a urine sample (Pregnancy test - HCG) been taken?
Item
Results
text
C0430056 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1])
Code List
Vaccine Administration
CL Item
Study vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not injected (4)
Item
Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Item
Site
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
CL Item
Deltoid (Deltoid)
CL Item
Buttock (Buttock)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration of vaccine, Study Protocol
Item
Has the study vaccine been administered according to the protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Administration of vaccine, Comment
Item
Comments
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item
Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period?
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Code List
Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period?
CL Item
Unknown (Unknown)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
CL Item
Redness (Redness)
CL Item
Redness Size (mm) (Redness Size (mm))
CL Item
Swelling (Swelling)
CL Item
Swelling Size (mm) (Swelling Size (mm))
CL Item
Pain Intensity (0-4) (Pain Intensity (0-4))
Vaccination, Symptoms, Local, Observation Start Day
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C2826301 (UMLS CUI [1,4])
Vaccination, Symptoms, Local, Day 1
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1442449 (UMLS CUI [1,4])
Vaccination, Symptoms, Local, Day 2
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3842676 (UMLS CUI [1,4])
Vaccination, Symptoms, Local, Day 3
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3842675 (UMLS CUI [1,4])
Vaccination, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Vaccination, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Item
Has the subject experienced any of the following general solicited signs or symptoms during the solicited period?
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
Code List
Has the subject experienced any of the following general solicited signs or symptoms during the solicited period?
CL Item
Unknown (Unknown)
Item
General Symptoms
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Code List
General Symptoms
CL Item
Temperature (°C) (Temperature (°C))
CL Item
Measurement Site (Axillary, Oral, Rectal) (Measurement Site (Axillary, Oral, Rectal))
CL Item
Fatigue? (Fatigue?)
CL Item
Intensity of fatigue (0-3) (Intensity of fatigue (0-3))
CL Item
Headache? (Headache?)
CL Item
Intensity of headache (0-3) (Intensity of headache (0-3))
CL Item
Gastrointestinal symptoms? (Gastrointestinal symptoms?)
CL Item
Intensity of gastrointestinal symptoms (0-3) (Intensity of gastrointestinal symptoms (0-3))
Vaccination, General symptom, Observation Start Day
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Vaccination, General symptom, Local, Day 1
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
Vaccination, General symptom, Day 2
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
Vaccination, General symptom, Day 3
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
Vaccination, General symptom, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Vaccination, General symptom, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Vaccination, General symptom, Etiology aspects
Item
Causality?
boolean
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])