27 girls report abnormal symptoms after receiving the cervical cancer vaccine
Published 05/11/2015 | 02:30
The parents of 27 Irish teenage girls have reported their daughters have suffered abnormal symptoms after receiving the cervical cancer vaccine, it has emerged.
These symptoms, which are outside the norm, include chronic fatigue, the country's medicines' watchdog revealed.
The figures come in advance of a study of the vaccine by a European safety body to be published today.
One Irish mother is now taking a High Court case alleging her daughter suffered serious reactions after receiving the HPV vaccine.
The European Medicines Agency's (EMA) probe was launched after several reports of abnormal reactions in girls in a number of countries.
A spokeswoman for the Health Products Regulatory Authority (HPRA), which monitors medicines here, told the Irish Independent yesterday that Gardasil is the HPV vaccine used in the schools immunisation programme in Ireland since May 2010.
It has been administered to approximately 644,161 girls in Ireland up to the end of quarter three this year. Since Gardasil was authorised in 2006, the HPRA has received 926 reports of suspected adverse reactions in association with it.
"Adverse events reported to date have included reports of dizziness, headache, fainting, injection site swelling, injection site pain, raised temperature, muscle pain, nausea and vomiting," said the watchdog.
"These reflect the adverse effects included in the approved product information for Gardasil."
Reports of persisting/chronic fatigue or severe pain, in some cases with other non-specific symptoms - for example drowsiness, gastrointestinal upset, joint swelling, flu like illness and menstrual disorders - have also been received.
"All of the reports received by the HPRA have been transmitted to the EudraVigilance database and are being considered in an EU level safety review for HPV vaccines," said the HPRA spokeswoman.
"This review is being conducted by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) where the HPRA contributes.
"Parents of 27 Irish girls have also, in addition to reports that they may have made to the HPRA, directly reported experiences in relation to chronic fatigue/complex regional pain to the PRAC which are being considered as part of this ongoing safety review.
"A survey of 50 further parents was also included in the data submitted to the EMA for review.
"The PRAC has completed a detailed scientific review of the evidence surrounding reports of two rare syndromes, in young women given human papillomavirus (HPV) vaccines," she added.
The analysis is due to be published today.