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Contraindications to subsequent vaccination

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Number
Beskrivning

Visit Number

Datatyp

integer

Alias
UMLS CUI [1]
C1549755
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Contraindications to subsequent Vaccination: GSK Biologicals' HRV vaccine or its placebo
Beskrivning

Contraindications to subsequent Vaccination: GSK Biologicals' HRV vaccine or its placebo

Alias
UMLS CUI-1
C0522473
UMLS CUI-2
C0597418
Hypersensitivity reaction due to the vaccine [A]
Beskrivning

This adverse event (AEs) constitutes an absolute contraindication to further administration of HRV vaccine or placebo; if this AE occurs during the study, the subject must not receive additional doses of vaccine but may continue other study procedures at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE:

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0597418
IS [B]
Beskrivning

This adverse event (AEs) constitutes an absolute contraindication to further administration of HRV vaccine or placebo; if this AE occurs during the study, the subject must not receive additional doses of vaccine but may continue other study procedures at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE:

Datatyp

boolean

Alias
UMLS CUI [1]
C0021933
Axillary temperature >= 37.5 °C, rectal temperature >= 38.0 °C [C]
Beskrivning

This AE constitutes a contraindication to administration of HRV vaccine or placebo at that point in time; if this AE occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE.

Datatyp

boolean

Alias
UMLS CUI [1]
C1531924
UMLS CUI [2]
C0489749
GE within 7 days preceding the study vaccine administration. [D]
Beskrivning

This AE constitutes a contraindication to administration of HRV vaccine or placebo at that point in time; if this AE occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE.

Datatyp

boolean

Alias
UMLS CUI [1]
C0017160
Contraindications to subsequent Vaccination: GSK Biologicals’ OPV
Beskrivning

Contraindications to subsequent Vaccination: GSK Biologicals’ OPV

Alias
UMLS CUI-1
C0522473
UMLS CUI-2
C0032375
Known systemic hypersensitivity to neomycin or to any other component of the vaccine. Contact dermatitis to neomycin is not a contraindication. [E]
Beskrivning

The following adverse event associated with OPV immunisation constitutes an absolute contraindication to further administration of OPV vaccine; if this adverse event occurs during the study, the subject must be withdrawn and must be followed until resolution of the event as with any adverse event:

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0027603
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0042210
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0027603
UMLS CUI [3,3]
C0011616
Subjects suffering from primary and secondary immunodeficiencies. However, symptomatic and asymptomatic infection with human immunodeficiency virus does not contraindicate immunisation with OPV. [F]
Beskrivning

The following adverse event associated with OPV immunisation constitutes an absolute contraindication to further administration of OPV vaccine; if this adverse event occurs during the study, the subject must be withdrawn and must be followed until resolution of the event as with any adverse event:

Datatyp

boolean

Alias
UMLS CUI [1]
C0398686
UMLS CUI [2]
C0398795
UMLS CUI [3,1]
C0332300
UMLS CUI [3,2]
C0019693
As with other vaccines, the administration of OPV should be postponed in subjects suffering from acute severe febrile illness, or persistent diarrhoea or vomiting. The presence of a minor infection, however, is not a contra-indication for immunisation. [G]
Beskrivning

Precaution

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0743842
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0011991
UMLS CUI [3,1]
C0042963
UMLS CUI [3,2]
C0205322
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Similar models

Contraindications to subsequent vaccination

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
Visit Number
Code List
Visit Number
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Contraindications to subsequent Vaccination: GSK Biologicals' HRV vaccine or its placebo
C0522473 (UMLS CUI-1)
C0597418 (UMLS CUI-2)
Hypersensitivity to vaccine
Item
Hypersensitivity reaction due to the vaccine [A]
boolean
C0020517 (UMLS CUI [1,1])
C0597418 (UMLS CUI [1,2])
IS
Item
IS [B]
boolean
C0021933 (UMLS CUI [1])
Axillary temperature >= 37.5 °C, rectal temperature >= 38.0 °C
Item
Axillary temperature >= 37.5 °C, rectal temperature >= 38.0 °C [C]
boolean
C1531924 (UMLS CUI [1])
C0489749 (UMLS CUI [2])
GE < 7 days before vaccine administration
Item
GE within 7 days preceding the study vaccine administration. [D]
boolean
C0017160 (UMLS CUI [1])
Item Group
Contraindications to subsequent Vaccination: GSK Biologicals’ OPV
C0522473 (UMLS CUI-1)
C0032375 (UMLS CUI-2)
hypersensitvity to neomycin or other vaccine component, except Neomycin contact dermatitis
Item
Known systemic hypersensitivity to neomycin or to any other component of the vaccine. Contact dermatitis to neomycin is not a contraindication. [E]
boolean
C0020517 (UMLS CUI [1,1])
C0027603 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0332300 (UMLS CUI [3,1])
C0027603 (UMLS CUI [3,2])
C0011616 (UMLS CUI [3,3])
primary or secondary immunodeficiencies except infection with HIV
Item
Subjects suffering from primary and secondary immunodeficiencies. However, symptomatic and asymptomatic infection with human immunodeficiency virus does not contraindicate immunisation with OPV. [F]
boolean
C0398686 (UMLS CUI [1])
C0398795 (UMLS CUI [2])
C0332300 (UMLS CUI [3,1])
C0019693 (UMLS CUI [3,2])
acute severe febrile illness, persistent diarrhoea, vomiting
Item
As with other vaccines, the administration of OPV should be postponed in subjects suffering from acute severe febrile illness, or persistent diarrhoea or vomiting. The presence of a minor infection, however, is not a contra-indication for immunisation. [G]
boolean
C0743842 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0011991 (UMLS CUI [2])
C0042963 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
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