Interpreting information on the Database of Adverse Event Notifications

Behind the news

3 August 2012

This TGA behind-the-news article was published on 3 August 2012. Behind-the-news articles are published in response to issues that are of interest to the community at a point in time, for example, subjects that have been in the media.

TGA is concerned by a media story that may mislead consumers and could potentially discourage them from receiving influenza vaccinations.

Vaccinations play an important role in the prevention of diseases such as influenza, which can be life threatening in some patient groups.

On Wednesday 1 August, the Australian Government launched the Therapeutic Goods Administration's online Database of Adverse Event Notifications which includes around 251,000 adverse event reports, dating back to 1971, about all medicines and vaccines as reported by consumers, health professionals and manufacturers.

The first line of text on the Database of Adverse Event Notifications states that: An Adverse Event does not mean that the medicine is the cause of the adverse event.

The TGA is concerned by assertions that a number of deaths resulted from influenza vaccinations. In fact there have been no recorded deaths from influenza vaccine in Australia.

Influenza and associated diseases like pneumonia, which are preventable by vaccines, kill around 2500 Australians each year and lead to thousands of hospitalisations. Vaccination provides the best form of defence against these killer diseases. Given the seriousness of this illness it is vitally important that data is not misinterpreted.

In accessing the database we encourage consumers to understand that a report of an adverse event does not necessarily indicate there is a causal link between a medicine and an adverse outcome.

We encourage you to visit the DAEN and follow the guidelines to fully understand the meaning of the data.