EU: no safety concerns as 10 million get H1N1 shots

Some 10 million people across the European Union have now been vaccinated against H1N1 swine flu and so far no unexpected serious safety issues have been identified, the region's drugs watchdog said on Thursday.

The most frequent adverse reactions have been fever, nausea, headache, allergic reactions and injection site pain, but these were mostly non-serious and had been expected, the European Medicines Agency said.

The safety update is the first analysis of adverse reactions following the roll-out of three vaccines across Europe -- GlaxoSmithKline's Pandemrix, Novartis's Focetria and Baxter's Celvapan.

New clinical trial data did show a greater incidence of fever following the second dose of Pandemrix in babies from 6 to 35 months and an assessment of that data was ongoing, the agency added.