December 3, 2009
This report summarises the adverse reactions suspected to have been caused by Cervarix human papillomavirus (HPV) vaccine in the UK. This includes reports received between 14 April 2008 and 2 December 2009. These reports have been voluntarily submitted to the MHRA by healthcare professionals and members of the public via the Yellow Card Scheme (visit HTUTUwww.yellowcard.gov.ukUTH) and by the manufacturers of the vaccine as part of their legal requirements.
It is essential to bear in mind that reports to the MHRA relate only to adverse medical events which the reporter considered could have been caused by the vaccine (i.e. if there was merely a suspicion of causality). Therefore, cases may be true side-effects or they may have been purely coincidental events due to underlying or undiagnosed illness that would have occurred anyway in the absence of vaccination. Events may also have been psychogenicTPTP1 PTPT in origin. This report therefore cannot be considered to represent a list of known side-effects of the vaccine. These data also cannot be used to determine the frequency, or incidence, of known side-effects because they are often under-reported. The known side-effects, and their frequencies (based on clinical trial data), are available in the product information (see HTUTUhttp://emc.medicines.org.uk/UTH).
The reactions in this report have been broken down into 5 categories based on scientific assessment of individual cases by MHRA assessors: injection-site reactions; allergic reactions; ‘psychogenic’ events; other recognised reactions; and ‘suspected adverse reactions not currently recognised’ (reactions in
this latter category are divided into the high-level classification of System Organ Class)TPTP 2 PTPT. The same event term may appear in more than one category (e.g. ‘rash’ may be associated with injection site, allergic or unrecognised suspected reactions and ‘psychogenic’ events). However, an event from a single report will appear in only one category.
A single report may contain more than one reaction, more than one sign or symptom of a single reaction or different reactions in more than one of the above categories. Therefore the total number of listed reactions is greater than the total number of reports and total reports in each of the 5 tables
should not be added together.
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