Swine flu update: 23 reports of adverse reactions to swine flu vaccines

The Irish Medicine Board (IMB) has received 23 reports of suspected adverse reactions to the Pandemic H1N1 vaccines Pandemrix and Celvapan.
As of 12 noon on Thursday November 5, seven suspected adverse reactions occurred in children and four in pregnant women.
The cases included injection site reactions (e.g. pain, swelling, bruising) or general adverse effects already listed in the product information based on the experience in the clinical trials — such as nausea, vomiting, muscle pain, fever, fatigue, headache, dizziness and suspected allergic reactions.
The IMB has received four reports in total of suspected allergic reactions to the Pandemic H1N1 vaccines. The Board has reminded healthcare professionals that, as with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a serious allergic reaction and in the event of a possible rare anaphylactic event.
Commenting on the figure, the IMB said that all of the reports received to date were consistent with the expected pattern for the pandemic vaccines, and that the benefit-risk profile remained positive.
The reports have been submitted to the IMB on a voluntary basis by GPs, other healthcare professionals and members of the public, either through the online reporting tool on the IMB website (www.imb.ie), or by post or telephone. The update also contains any notifications by the marketing authorisation holders for Pandemrix (GSK) and for Celvapan (Baxter).
Reporters are encouraged to forward on details of any suspected adverse reactions to the IMB. They do not have to be sure that the vaccine caused the reaction; a mere suspicion will suffice.
Due to this criteria, the reports received to date may be true adverse reactions to the vaccine or events related to the process of vaccination rather than to the specific vaccine itself. They may also be coincidental events, which have occurred post-vaccination but which would have occurred anyway even if vaccination had not taken place, for example, in the case of an underlying medical condition.
Doctors can obtain the latest information on Pandemrix and Celvapan, including information on recognised adverse effects, on the IMB website and on the site of the European Medicines Agency.