Human papillomavirus (HPV) vaccine – reactions reported via the Yellow Card Scheme

Human papillomavirus (HPV) immunisation programme – a vaccine to prevent cervical cancer

MHRA
United Kingdom

Introduction
A routine immunisation programme for human papillomavirus (HPV) started across the UK on 1 September 2008 for 12–13-year-old girls (school year 8). The vaccine given is called Cervarix, which protects against infection with HPV types 16 and 18.

Infection with HPV is one of the most common sexually transmitted diseases. Genital infection with a high-risk (or ‘oncogenic’—potentially cancer-causing) HPV virus is the main cause of cervical cancer and is responsible for nearly 3000 cases of cervical cancer every year in the UK: HPV types 16 and 18 cause around 70% of cases. Immunising girls before they become infected could eventually prevent up to 400 deaths every year in the UK.

As well as routine immunisation of girls in school year 8, there will be a phased catch-up of girls currently aged up to 18 years. In England, 17–18-year-old girls will also be offered the vaccine during the coming year, with the remaining girls immunised during 2009 to 2011. The timing of the catch-up programmes may differ in Scotland, Wales and Northern Ireland.

Vaccine safety
The safety and efficacy of Cervarix vaccine has been extensively studied in clinical trials before licensing. The most common side-effects identified are injection-site reactions, fever, headache, fatigue, muscle pain, nausea, vomiting, and diarrhoea, which are listed in the product information (please refer to the Summary of Product Characteristics and Patient Information Leaflet available via the Electronic Medicines Compendium – http://emc.medicines.org.uk (external link)).

However, as with all vaccines and medicines used in the UK, it is important that the MHRA continues to monitor the safety of Cervarix vaccine during routine use.

Another HPV vaccine called Gardasil is also licensed and on the UK market outside of the national immunisation programme. The MHRA is also responsible for monitoring the safety of Gardasil vaccine.

Reporting of suspected side effects (adverse reactions)
One way that MHRA monitors vaccine safety is through reporting of suspected side effects (adverse reactions) via the Yellow Card Scheme.

Please report via the Yellow Card Scheme suspected adverse reactions that may have occurred after administration of HPV vaccine (see www.yellowcard.gov.uk). You can send Yellow Cards by post, but we strongly encourage you to report online. This will allow us quick access to your Yellow Card report.

When submitting a Yellow Card, please include:

  • suspected adverse reaction(s): please report only the main diagnosis as the suspected side-effect; signs and symptoms can be included as additional information if necessary
  • vaccine brand name
  • vaccine batch number (if available)
  • time to onset (if known)
  • age and gender of the person who had the adverse reaction
  • your contact details, should we need further information

Many adolescents will be immunised with Cervarix vaccine over a relatively short time. Adherence to the specific guidance outlined below will help us monitor the safety of the vaccine effectively and communicate any information promptly.

Faints and panic attacks
Fainting can occur during, following, or even before, vaccination and occurs most commonly in adolescents. Some individuals may also experience panic attacks before vaccination. The clinical features of fainting and panic attacks are described in detail in chapter 8 of the ‘Green Book’ (external link) . Fainting can result in traumatic injury, and local procedures should be in place to observe and manage such events. It is important that any sudden loss of consciousness or generalised reaction is distinguished from a possible anaphylactic (or severe allergic) reaction (see below).

Fainting and panic attacks can occur during any injection procedure. When an episode occurs during or very shortly after vaccination, it is highly unlikely to be a true-side effect of the vaccine itself and is most likely a psychogenic response to the injection process. Only reactions that are suspected to be related to the vaccine (and not those associated with the injection process) should be reported via the Yellow Card Scheme.

If having considered this advice, you wish to report a possible psychogenic response, please include only the main diagnosis or event as the suspected reaction (eg, ‘faint’, ‘vasovagal syncope’, or ‘panic attack’). Any signs or symptoms associated with these events (eg, loss of consciousness, injury, limb jerking or tingling, difficulty in breathing, hyperventilation) should not be reported as a suspected adverse reaction. If necessary, they can be included as ‘additional information’ on the Yellow Card.

Since episodes of mass fainting and/or panic attacks can occur during a large immunisation session we request that you adhere to the above guidance to allow an appropriate assessment and a proportionate response to such incidents.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.