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source: Irish Times
By Carl O'Brien
ALMOST 500 people have developed suspected adverse reactions from the swine flu vaccine, new figures show.
At least 300,000 doses of the vaccine have been administered to date, but no serious safety issues have yet been identified, according to the Irish Medicines Board (IMB).
The most frequent adverse reactions have been fever, nausea, headache and allergic effects. These reports are consistent with the expected pattern of adverse reactions for the vaccines, according to the board.
The two versions of the vaccine – GlaxoSmithKline’s Pandemrix and Baxter’s Celvapan vaccine – have attracted similar numbers of suspected adverse reactions. The IMB says the balance of risks and benefits for both vaccines remain positive.
The general pattern of adverse reactions in Ireland is reflected across Europe where some 10 million people have been vaccinated against swine flu, according to the European Medicines Agency.
Officials say adverse reactions are not necessarily caused by the vaccine. They could be a symptom of another illness or they could be associated with another product taken by the patient.
Healthcare professionals are actively encouraged to report any suspected adverse events following vaccination.
By last Thursday the Pandemrix vaccine had received a total of 234 adverse reaction reports.
The most frequently reported suspected reactions were “injection site” reactions (such as pain, swelling, redness), gastro-intestinal symptoms (nausea, vomiting, diarrhoea) and flu-like symptoms (pain, fever, fatigue and swollen glands).
Last week also, the European Medicines Agency warned that young children may experience fever after their second dose of the Pandemrix vaccine. Following an ongoing clinical trial, the agency said this information should be included in the prescribing information, and be taken into consideration when deciding whether to give a second dose to children.
Of the suspected overall number of adverse reactions, the IMB received 14 reports relating to pregnant women. The reactions included dizziness, pins and needles and weaknesses in vaccinated limbs. There have been two reports of “facial palsy” – weakness of the facial muscles – following vaccination. An investigation is ongoing to establish whether these can be directly linked to the vaccine.
There has been a similar pattern in relation to the Celvapan vaccine, which has formed the basis for 233 suspected adverse reactions. These include injection site reactions, flu-like illness and allergic-type reactions. There have also been reports of nausea and vomiting, some of which were serious and required treatment. Also, one patient died 10 days after being vaccinated with Celvapan.
However, the patient had a number of underlying conditions including cardiac disorders and diabetes. The IMB said there was no evidence of a causal relationship between vaccination and the patient’s death.
A total of 19 adverse reaction reports were received in respect of pregnant women. They included gastrointestinal symptoms, flu-like symptoms and vaccination-related events such as dizziness.
Both vaccines have resulted in 483 adverse reactions. The vaccine used in 16 of these reactions has yet to be established.
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