More than 80 per cent of girls who required medical intervention after receiving the HPV vaccine suffered only “transient” symptoms, according to the State’s medicines watchdog.
The Health Products Regulatory Authority was responding to an Irish Times report that almost 650 girls required medical treatment after receiving the vaccination.
In confirming the number of girls reporting side-effects that were categorised as serious (648), the authority stressed the vast majority of these cases involved treatment of “vaccination-related events”.
These include fainting around the time of vaccination, or treatment for injection site reactions such as headache, rash, itching (or other allergic-type reactions), fever, muscle pain and gastrointestinal effects, such as nausea and vomiting.
Minimal intervention
“Such reactions are typically transient in nature and require minimal medical intervention,” according to a spokeswoman from the authority.
Reports can include fainting that occurred before, during or after the vaccination is administered, she said.
“Fainting sometimes can occur following or even before vaccination especially in adolescents as a psychogenic response to the needle injection,” the summary of product characteristics for the vaccine, marketed as Gardasil, states.
“The authority takes all information provided when they get a report; they seek to follow up for more detail but at times there only information they can use is the information initially provided,” the spokeswoman said.
“The authority welcomes reports as they provide information on the ongoing national experience of use – reports often provide further evidence of the already known side effects of a medicine, which is helpful in terms of the ongoing monitoring of its safety profile.”
The reported side-effects in relation to Gardasil do not include any fatalities, the authority’s spokeswoman confirmed.
Last year, the authority received a total of 3,264 reports of new adverse reaction reports occurring in Ireland associated with use of human medicines. Some 119 reports of these reports related to the use of HPV vaccines.
Since it was introduced in Ireland in 2010, more than 690,000 doses of the vaccine have been distributed, and 230,000 girls have received the full vaccine course.
