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  • Aim of this SMQ is to support database searches for potentially drug/vaccine related hypersensitivity/allergic reactions in connection with Risk Management Plans, PSUR and other surveillance activities; designed to retrieve all types of cases possibly related to hypersensitivity/ allergic reactions; SMQ is not intended to differentiate between different types of hypersensitivity reactions such as the Coombs classification. A number of SMQs for specific allergic conditions already exist (e.g. SMQ Anaphylactic reaction, SMQ Angioedema). \'Hypersensitivity\' is often used in a very general way to describe a large number of conditions related to an exaggerated response of the body to a foreign agent; a more restricted use is for allergic reactions of all types. Many terms included in SMQ Hypersensitivity do not permit differentiation between hypersensitivity/allergic reactions and other causes for the given event and therefore further analysis of cases retrieved by the SMQ is required.
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Metadata

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