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 Gardasil as they 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 on-going 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 (www.hpra.ie) using the on-line form accessible via the ‘Report an issue’ tab on the HPRA website homepage.
- Through the HPRA website (www.hpra.ie) using the downloadable form accessible via the ‘Report an issue’ tab on the HPRA website homepage. The form 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.
- By emailing the HPRA Pharmacovigilance department at firstname.lastname@example.org
- By calling the HPRA on 01-676 4971.
Healthcare professionals may also report suspected adverse reactions using the above methods. Any queries in respect of adverse reaction reporting may be addressed to the HPRA Pharmacovigilance section at email@example.com.