Vaccine
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Our study reviews the spontaneous reports of adverse events following immunisation submitted to the Danish Medicines Agency during the 2009-2010 influenza A/H1N1v season. During the study period (4 November 2009-31 March 2010), 607 reports comprising 1885 adverse events were reported among 339,507 influenza A/H1N1v vaccinated individuals (reporting rate, 179 per 100,000 vaccinated). ⋯ In conclusion, we did not observe any strong signals of any unknown or serious adverse events associated with influenza A/H1N1v vaccination in Denmark. Our experience also demonstrates the well-known limitations of spontaneous reports with respect to evaluation of a casual relationship and highlights the importance for a timely availability of background events rates and the need for new approaches to study late adverse effects following immunisation.
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Intramuscular vaccination may lead to loss of subcutaneous fat resulting in skin depression at the site of injection. We report for the first time a delayed lipoatrophy after with AS03-adjuvanted influenza A (H1N1) 2009 vaccine. Inadequate administration into the adipose tissue may be causative. During next pandemic, education to optimal intramuscular administration and prolonged monitoring of adverse effects could be proposed.