Reporting Suspected Side Effects

Many adolescents will be immunised with Gardasil in Ireland over a relatively short period of time. As no vaccine is without side effects, all adverse reactions or events following immunisation with Gardasil will be closely monitored by the Irish Medicines Board (IMB).

It is very important that suspected side effects from the use of a medicine are reported as these reports allow the IMB to monitor the safety of each product as it is used. It is also an important way of identifying any new potential safety issues with medicines. When the IMB receives a report of a suspected side effect, it evaluates the case and considers whether this may be a new safety concern or whether similar cases have been previously reported. The IMB also has access to global safety information which helps in identifying emerging safety issues.

Members of the public
If you are concerned that you have had a side effect to this or any medicine, contact your doctor or pharmacist who will advise on any treatment you may need. They may also report the suspected side effect to the IMB. Should you wish, you can also report side effects directly to the IMB.

While a report of a side effect does not necessarily mean that it is has been caused by the medicine you took or received, the IMB encourages people to report all suspected side effects.

You can report a suspected side effect or adverse reaction in a number of ways:
1. To your doctor, pharmacist or nurse who can then notify the IMB.
2. On the IMB website
3. By calling the IMB on (01) 676 4971

Healthcare professionals
In advance of commencement of the immunisation programme, the IMB wrote to all healthcare professionals involved to encourage use of the national spontaneous reporting system to report suspected side effects. Adverse reactions may be reported using the on-line form. A downloadable version of the form is also available, which can be filled in manually and sent to the IMB by freepost.

If you have any queries in respect of adverse reaction reporting, please contact the pharmacovigilance unit at imbpharmacovigilance@imb.ie or on (01) 676 4971.

The Irish Medicines Board - www.imb.ie

Reporting Suspected Side Effects