HPV vaccination is administered to a young girl. Photo by
Gregor Richardson.
To the end of last year, 10 serious adverse events
following vaccinations with the human papilloma virus (HPV)
vaccine Gardasil were reported to the national Centre for
Adverse Reactions Monitoring (Carm) in Dunedin.
These include a report of a sudden death occurring six months
after the third dose of the vaccination, a report from Carm
director Dr Michael Tatley says.
The cause of that death has not been reported and is still
under coronial investigation.
There was also one report of a life-threatening event
involving tongue-swelling related to severe hypersensitivity.
Three hospitalisations were recorded for a variety of
symptoms including convulsions some time after the
vaccination, and fainting episodes.
Dr Tatley said reports were classified as serious because of
the nature of the event, irrespective of whether it was
considered to be caused by the vaccine.
Dr Tatley said there were a further 20 reports, not
categorised as serious according to World Health Organisation
criteria, but which described events severe enough to lead to
the young women attending emergency or after-hours care.
These included reports of collapse, allergic reactions,
convulsion episodes and one case of severe arm pain.
There was one report describing an event suggesting
anaphylaxis (a severe allergic reaction) but it did not meet
the standard case definition for this and the person
recovered rapidly.
All those providing the vaccinations must have drugs on hand
to treat such episodes, even though they were rare.
Dr Tatley said overall the patterns of events observed were
typical of postimmunisation symptoms and raised no safety
issues of concern.
By the end of December, 236,299 doses of HPV vaccine had been
recorded as being administered with a total of 236 reports of
adverse events following immunisation.
The most common symptom reported was injection site reactions
(78), followed by nausea, vomiting and diarrhoea (75), skin
reactions (61) and headache (44).
Some patients reported more than one reaction.
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