Adverse reactions to drugs and vaccine are common and may be serious, with the risk of leading to hospital admission, delayed discharge from hospital or death. It has been estimated that up to two-thirds of the ADRs may be preventable, or interrupted before they become severe.
Communication materials on additional monitoring and the inverted black triangle symbol have been produced in all EU languages. For further details see the factsheet and video below and the EMA Press Release.
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Video in English