Reporting Suspected Side Effects

As no medicine, including vaccines, is without side effects, the Health Products Regulatory Authority (HPRA) encourages reporting of any suspected adverse reactions following immunisation with the HPV vaccines, as these reports provide information on the ongoing national experience of use. All reports received by the HPRA are reviewed and followed up as necessary to ensure all relevant information is available, prior to anonymised onward reporting to relevant stakeholders, as per legislative requirements, including the European Medicines Agency (EMA), the World Health Organisation (WHO) and the relevant Marketing Authorisation Holder (MAH; i.e. license holder for the medicine in question). At EU level, regulators continuously monitor cumulative reporting experience as part of the ongoing assessment of the safety of medicines/vaccines.

Members of the public

If you are concerned that you, or a person you are caring for, may have experienced a side effect to the HPV vaccine, please contact your doctor, pharmacist or another healthcare professional involved in your care who will advise you on any intervention or treatment needed. Suspected side effects may also be reported directly to the HPRA and patients/carers are encouraged to do so.

Suspected side effects/adverse reactions may be reported in a number of ways, as follows:

• To your doctor, pharmacist or nurse who can then notify the HPRA.
• Through the HPRA website using the available options:
  • The online form
  • The downloadable form, which can be completed in confidence and returned to the HPRA using the following Freepost address: Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02 XP77.
  • By emailing the HPRA Pharmacovigilance department at medsafety@hpra.ie
  • By calling the HPRA on 01 676 4971.

Healthcare professionals

Healthcare professionals may also report suspected adverse reactions using the above methods (see www.hpra.ie/report for further information). Any queries in respect of adverse reaction reporting may be addressed to the HPRA Pharmacovigilance section at medsafety@hpra.ie.