Dáil Éireann Debate, Wednesday - 30 May 2018
138. Deputy Clare Daly asked the Minister for Health the reason cases of suspected adverse reactions to the HPV vaccine Gardasil previously listed as convulsions were recently amended on the HPRA line listing report to seizures; if these amendments were notified to the EMA EudraVigilance database; if the attention of the case ID patient holder is drawn to such changes to their records; and if he will make a statement on the matter. [23836/18]
View answerThe information that the Deputy seeks is not readily available. Therefore, I have asked the Health Products Regulatory Authority (HPRA) to investigate the matter and reply directly to the Deputy.
It is important to reiterate that the HPRA and the European Medicines Agency continually monitor adverse events to vaccination. HPV is one of the most closely studied and monitored medicinal products. The vast majority of reports received by the HPRA have been consistent with the expected pattern of short term adverse side effects for the vaccine, as described in the product information. Mild and temporary reactions to any kind of vaccination are not unusual.
