Dáil Éireann Debate, Tuesday - 21 January 2014
636. Deputy Caoimhghín Ó Caoláin asked the Minister for Health if he will provide the list of all side effects of the swineflu vaccine Pandemrix reported to the Health Service Executive since 2010, both including and excluding narcolepsy; the numbers of reported incidents of these side effects also including and excluding narcolepsy; and if he will make a statement on the matter. [2727/14]
View answerThe competent authority for licensing and safety of all medicines, including vaccines licensed in Ireland is the Irish Medicines Board (IMB). From 2010 to date, the IMB has received 783 reports of suspected adverse reactions to Pandemrix, the majority of which are consistent with the known effects of the vaccine as described in the product information (product information for all authorised products is publically accessible via the IMB website). The most frequently reported reactions included the following: 754 - Nervous system disorders including dizziness, headache, fainting, and drowsiness; 485 - General disorders including fatigue, injection site reactions, temperature changes and weakness; 259 - Gastrointestinal disorders including nausea, vomiting, diarrhoea and abdominal pain; 127 - Skin and hypersensitivity disorders including rash and allergic type effects; 121 - Musculoskeletal disorders including muscle pain and muscle weakness.
Many of the reports describe a number of reactions, so the number of reactions exceeds the number of reports. To date, the IMB has received reports of 49 cases with clinical information confirming a diagnosis of narcolepsy in relation to individuals vaccinated with Pandemrix. However the IMB is awaiting information on further possible cases where clinical investigations are ongoing and is actively following up to obtain this information. Overall updates on national adverse reaction reporting experience are shared with relevant HSE groups, including the Health Protection Surveillance Centre, the National Immunisation Office and with representatives of the Department of Health through the National Immunisation Advisory Committee (NIAC), at which all of the relevant groups are represented.
