National Monitoring Experience
Updates on national monitoring experience were published on the HPRA (then IMB) website during the first year of the HSE Schools Immunisation Programme with the final update published in July 2011.
Adverse reaction (side effect) reports
From the time of first authorisation of Gardasil in 2006 and up to 31 December 2022, the HPRA has received 1544* reports of suspected adverse reactions and events associated with use of the HPV vaccines (Gardasil, Gardasil 9, Cervarix, with a few reports for which the brand of vaccine is not known). This level of reporting for the HPV vaccines reflects the very positive response to calls for reporting of the national experience associated with use of the vaccines.
The majority of reports received by the HPRA have been consistent with the known pattern of adverse reactions/events for the vaccines, as described in the product information (Summary of Product Characteristics (SmPC) and Package Leaflet (PL)). Vaccination-related events, occurring at the time of vaccine administration, such as syncope (faints) have been among the most commonly reported effects. Other commonly reported symptoms include gastrointestinal symptoms, malaise, headache, dizziness and injection site reactions.
Reports of allergic-type reactions including skin rashes, urticaria and flushing have also been received, including isolated reports of more severe hypersensitivity-type reactions. There have also been some reports describing persisting/chronic fatigue, generally with multiple other symptoms (e.g. headache, malaise, drowsiness, nausea, gastrointestinal upset, joint swelling, flu-like illness, menstrual disorders) following vaccination.
Of the reports received, approximately 50% have been categorised as serious (801 reports classified as ‘serious’ – 801/1544 = 51.87%). This is based on the regulatory definition of a ‘serious’ adverse reaction, which includes circumstances where patients require intervention (e.g. review by their GP) and/or treatment for their symptoms. In the majority of these cases, the medical care required was for the treatment of vaccination-related events, such as fainting around the time of vaccination, or treatment for injection site reactions, headache, rash, itching (or other allergic-type reactions), fever, muscle pain and gastrointestinal effects, such as nausea and vomiting. Such reactions are typically transient in nature and require minimal medical intervention.
It is important to note that reports submitted to the HPRA concern ‘suspected’ adverse reactions. This means that the effects experienced may represent side effects associated with the vaccine/vaccination process, or may be coincidental in terms of timing, due to an underlying or previously undiagnosed condition that would have occurred in the absence of vaccination. Adverse reaction reporting rates for medicines, including vaccines, are influenced by a number of factors including the circumstances of their use, their ease of recognition, and extent of use.
*Please note that these figures are subject to constant change as new reports are received or information is provided that identifies an existing report as a duplicate of another case, leading to reconciliation of report under a unique identifying number.