Update on National Monitoring Experience with Gardasil

IRISH MEDICINES BOARD

11th November 2010

The HSE human papillomavirus (HPV) Schools Immunisation Programme commenced in May 2010. It is estimated that 60,000 doses of Gardasil have been distributed and approximately 45,000 doses have been administered up to the end of October 2010.

The Irish Medicines Board (IMB) has received a total of 64 reports of adverse events associated with use of Gardasil up to the end of October 2010, 55 of which were received since the beginning of the Schools Immunisation Programme. Suspected adverse reaction reporting rates are highly variable and are dependent on many factors. Therefore these data cannot be used to determine the frequency of occurrence of adverse reactions to Gardasil. A
single report may include more than one suspected reaction.

The majority of the reports have been consistent with the expected pattern of adverse effects for the vaccine, as outlined in the product information, and include cases of injection site reactions, malaise, headache, dizziness, fainting, fatigue and gastrointestinal symptoms.

There have been two reports of seizures, one occurring in a patient with a history of epilepsy.
Vaccination related events most commonly reported include reports of syncope (faints),
sometimes in conjunction with seizure-like movements, along with reports of dizziness and hyperventilation. Healthcare professionals are reminded that patients should be carefully observed for an appropriate period of time after administration of Gardasil (see Summary of Product Characteristics for further information). In accordance with local guidance, patients should be in a seated position during vaccination administration and should remain in the
vicinity of the place of vaccination for up to 15 minutes.

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