Possible Side Effects of Vaccination

Gardasil has been authorised for use across the European Union since 2006, with significant post-marketing experience both within and outside the EU.

The most commonly occurring side-effects were identified in the clinical trials and have been listed in the product information since the time of authorisation. Since then, the vast majority of suspected adverse reactions have related either to the signs and symptoms of recognised side effects listed in the product information or were due to the injection process and not the vaccine itself (i.e. ‘psychogenic’ in nature).

The most common side effects with Gardasil are pyrexia, pain, erythema and swelling at the injection site.

Gardasil should not be used in people who may be hypersensitive to the active substance or any of the other ingredients. If a patient shows signs of an allergy after a dose of Gardasil, she should not receive further doses of the vaccine. Vaccination should be postponed in patients who are ill with a high fever.

Fainting (or vasovagal syncope) and panic attacks, including mass episodes, can occur during, following, or even before, vaccination especially in adolescents and young adults. Syncope, sometimes associated with falling, has occurred after vaccination with Gardasil. Therefore, vaccinees should be carefully observed for an appropriate period of time after administration of Gardasil (see the Summary of Product Characteristics for further information). Faints or panic attacks occurring during or very shortly after vaccination are usually a psychogenic response to the needle injection and not a true side-effect of the vaccine.

Anaphylaxis is a very rare side-effect of most vaccines. The IMB continues to remind healthcare professionals that, as with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a serious allergic reaction and possibly a rare anaphylactic event following the administration of the vaccine. An appropriate post-vaccination monitoring period should be observed in line with local guidance.

Many adolescents will be immunised with Gardasil in Ireland over a relatively short period of time in the coming months. A significant volume of reporting of adverse events is often seen shortly after the introduction of a vaccine to a national immunisation campaign because of the increased exposure, higher degree of vigilance and limited national experience with the new product. Many of the reported events may be equally common in people of the same age who have not received the vaccine. Therefore, epidemiological methods are generally required to detect and investigate potential safety signals.

The Irish Medicines Board - www.imb.ie

Possible Side Effects of Vaccination