Englisch

Booster Dose

1 Formulare  
  1. StudyEvent: ODM
    1. Booster Dose
Administrative Data
Beschreibung

Administrative Data

Subject Number
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Unsolicited Adverse Events
Beschreibung

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination or any serious/specific adverse events at any time post vaccination ?
Beschreibung

Adverse Event, Vaccination, Post

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0042196
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - Hib-MenCY-TT vaccine
Beschreibung

Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - Hib-MenCY-TT vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Hib-MenCY-TT vaccine
Beschreibung

Hib-MenCY-TT vaccine

Datentyp

text

Alias
UMLS CUI [1]
C2352428
Local Symptoms
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - M-M-R® II Vaccine
Beschreibung

Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - M-M-R® II Vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
M-M-R® II Vaccine
Beschreibung

Vaccines

Datentyp

text

Alias
UMLS CUI [1]
C0042210
Local Symptoms
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - Varivax® vaccine
Beschreibung

Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - Varivax® vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Varivax® vaccine
Beschreibung

Vaccines

Datentyp

text

Alias
UMLS CUI [1]
C0042210
Local Symptoms
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Adverse Events - Local Symptoms - ActHIB group - PedvaxHIB® vaccine
Beschreibung

Adverse Events - Local Symptoms - ActHIB group - PedvaxHIB® vaccine

PedvaxHIB® vaccine
Beschreibung

Vaccines

Datentyp

text

Alias
UMLS CUI [1]
C0042210
Local Symptoms
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - Local Symptoms - ActHIB group - M-M-R® II Vaccine
Beschreibung

Solicited Adverse Events - Local Symptoms - ActHIB group - M-M-R® II Vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
M-M-R® II Vaccine
Beschreibung

Vaccines

Datentyp

text

Alias
UMLS CUI [1]
C0042210
Local Symptoms
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - Local Symptoms - ActHIB group - Varivax® vaccine
Beschreibung

Solicited Adverse Events - Local Symptoms - ActHIB group - Varivax® vaccine

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Varivax® vaccine
Beschreibung

Vaccines

Datentyp

text

Alias
UMLS CUI [1]
C0042210
Local Symptoms
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 0
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 1
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 2
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Day 3
Beschreibung

Vaccination, Adverse Event, Symptoms, Local

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Ongoing after day 3?
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0549178
Date of last day of symptoms
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0806020
Medically attended visit
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
Medically attended visit - Type
Beschreibung

Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
UMLS CUI [1,5]
C0545082
UMLS CUI [1,6]
C1386497
UMLS CUI [1,7]
C0332307
Solicited Adverse Events - General Symptoms
Beschreibung

Solicited Adverse Events - General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0159028
Has the subject experienced any of the following signs/symptoms during the solicited period ?
Beschreibung

Adverse Event, General symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
General Symptoms
Beschreibung

Adverse Event, General symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 0
Beschreibung

Adverse Event, General symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 1
Beschreibung

Adverse Event, General symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 2
Beschreibung

Adverse Event, General symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Day 3
Beschreibung

Adverse Event, General symptom

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
Ongoing after day 3?
Beschreibung

Adverse Event, General symptom, Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0549178
Date of last day of symptoms
Beschreibung

Adverse Event, General symptom, End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0806020
Causality
Beschreibung

Adverse Event, General symptom, Etiology aspects

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0015127
Medically attended visit
Beschreibung

Adverse Event, General symptom, Visit, Advice, Medical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C1386497
Medically attended visit - Type
Beschreibung

Adverse Event, General symptom, Visit, Advice, Medical, Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C1386497
UMLS CUI [1,5]
C0332307
Fever
Beschreibung

Adverse Event, General symptom, Fever

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0015967
General rash/ exanthema
Beschreibung

Adverse Event, General symptom, Exanthema

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0015230
Parotid / salivary gland swelling
Beschreibung

Adverse Event, General symptom, parotid gland swelling, Swelling of salivary gland

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0240668
UMLS CUI [1,4]
C0240925
Febrile convulsions –suspected signs of meningism
Beschreibung

Adverse Event, General symptom, Febrile Convulsions

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0009952
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Ähnliche Modelle

Booster Dose

1 Formulare
  1. StudyEvent: ODM
    1. Booster Dose
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination or any serious/specific adverse events at any time post vaccination ?
text
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Adverse Event, Vaccination, Post
Code List
Has the subject experienced any non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination or any serious/specific adverse events at any time post vaccination ?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (4)
Item Group
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - Hib-MenCY-TT vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Hib-MenCY-TT vaccine
text
C2352428 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
Hib-MenCY-TT vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - M-M-R® II Vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
M-M-R® II Vaccine
text
C0042210 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
M-M-R® II Vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - Varivax® vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Varivax® vaccine
text
C0042210 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
Varivax® vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Adverse Events - Local Symptoms - ActHIB group - PedvaxHIB® vaccine
Item
PedvaxHIB® vaccine
text
C0042210 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
PedvaxHIB® vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - Local Symptoms - ActHIB group - M-M-R® II Vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
M-M-R® II Vaccine
text
C0042210 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
M-M-R® II Vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - Local Symptoms - ActHIB group - Varivax® vaccine
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Varivax® vaccine
text
C0042210 (UMLS CUI [1])
Hib-MenCY-TT vaccine
Code List
Varivax® vaccine
CL Item
No  (1)
CL Item
Information not available  (2)
CL Item
No vaccine administered (3)
CL Item
Yes (4)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness, give size (mm) (1)
CL Item
Swelling, give size (mm) (2)
CL Item
Pain, give intensity (3)
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Day 0
Vaccination, Adverse Event, Symptoms, Local
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0549178 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0806020 (UMLS CUI [1,5])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
Vaccination, Adverse Event, Symptoms, Local, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C0545082 (UMLS CUI [1,5])
C1386497 (UMLS CUI [1,6])
C0332307 (UMLS CUI [1,7])
Item Group
Solicited Adverse Events - General Symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period ?
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period ?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)
Item
General Symptoms
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Code List
General Symptoms
CL Item
Irritability / Fussiness (give intensity) (3)
CL Item
Drowsiness (give intensity) (4)
CL Item
Loss of appetite (give intensity) (5)
Adverse Event, General symptom
Item
Day 0
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 1
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 2
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom
Item
Day 3
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Adverse Event, General symptom, Continuous
Item
Ongoing after day 3?
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Adverse Event, General symptom, End Date
Item
Date of last day of symptoms
date
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Adverse Event, General symptom, Etiology aspects
Item
Causality
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
Adverse Event, General symptom, Visit, Advice, Medical
Item
Medically attended visit
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,4])
Adverse Event, General symptom, Visit, Advice, Medical, Type
Item
Medically attended visit - Type
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C1386497 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,5])
Adverse Event, General symptom, Fever
Item
Fever
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Adverse Event, General symptom, Exanthema
Item
General rash/ exanthema
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0015230 (UMLS CUI [1,3])
Adverse Event, General symptom, parotid gland swelling, Swelling of salivary gland
Item
Parotid / salivary gland swelling
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0240668 (UMLS CUI [1,3])
C0240925 (UMLS CUI [1,4])
Adverse Event, General symptom, Febrile Convulsions
Item
Febrile convulsions –suspected signs of meningism
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0009952 (UMLS CUI [1,3])
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