Spontaneous reporting of adverse events following immunisation against pandemic influenza in Denmark November 2009-March 2010.
作者： Maja Folkenberg , Torbjörn Callréus , Henrik Svanström , Palle Valentiner-Branth , Anders Hviid
DOI: 10.1016/J.VACCINE.2010.12.008
关键词:
摘要: Our study reviews the spontaneous reports of adverse events following immunisation submitted to Danish Medicines Agency during 2009–2010 influenza A/H1N1v season. During period (4 November 2009–31 March 2010), 607 comprising 1885 were reported among 339,507 vaccinated individuals (reporting rate, 179 per 100,000 vaccinated). The majority individual case safety (85%) by physicians and other health care professionals concerned known non-serious reactions occurring within 1 day vaccination (82%). Events special interest as defined EMA prior campaign start, comprised 1% all events. In conclusion, we did not observe any strong signals unknown or serious associated with in Denmark. experience also demonstrates well-known limitations respect evaluation a casual relationship highlights importance for timely availability background rates need new approaches late effects immunisation.
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