UK: HPV vax - reporting adverse reactions via the Yellow Card Scheme

[Guest guest]

" Please report only reactions that you

suspect may be related to the vaccine and not

those associated with the injection process or procedure – see below. "

3 September

2008

Gateway approval reference number 10504

Dear Colleague

Human papillomavirus (HPV) immunisation programme

– reporting adverse reactions via the Yellow Card Scheme

The routine immunisation programme for HPV

vaccine, Cervarix, is commencing across the UK. I

am writing to clarify arrangements for reporting

suspected adverse reactions (ADRs) via the Yellow

Card Scheme and to seek your help in optimising

the value of reporting in relation to Cervarix.

Many adolescents will be immunised with the

vaccine over a relatively short time in the

coming months. Following the specific guidance

outlined below will help us monitor the safety of

Cervarix vaccine effectively. The most common

side-effects have been established in clinical

trials and these are listed in the product

information (available via

<http://emc.medicines.org.uk/>http://emc.medicines.org.uk).

However, as with all vaccines and medicines used

in the UK, it is important that the MHRA monitors

the safety of Cervarix during routine use.

How to report a suspected ADR

· Please report via the Yellow Card

Scheme ADRs that you suspect may have been caused by Cervarix.

We strongly encourage you to report online at

<http://www.yellowcard.gov.uk/>www.yellowcard.gov.uk

If you need a paper form, these are available in the BNF.

· Please report only reactions that you

suspect may be related to the vaccine and not

those associated with the injection process or procedure – see below.

Faints and panic attacks

Fainting (or vasovagal syncope) and panic

attacks, including mass episodes, can occur

during, following, or even before, vaccination.

The clinical features of such events are

described in chapter 8 of the ‘Green Book’. It is

important that procedures are in place to avoid

injury from faints and to ensure that any sudden

loss of consciousness is distinguished from a

possible anaphylactic reaction (see

below). Faints or panic attacks occurring during

or very shortly after vaccination are usually a

psychogenic response to the needle injection and

not a true side-effect of the vaccine.

If having considered this advice, you wish to

report an episode which may have been

psychogenic, please include only the main

diagnosis or event as the suspected reaction

(e.g. 'faint' or 'panic attack'). Any associated

symptoms (such as loss of consciousness, injury,

limb jerking or tingling, difficulty in

breathing, hyperventilation etc) should not be

reported as a suspected adverse reaction. If

necessary, they can be included as 'additional information' on the form.

Anaphylaxis and other allergic reactions

Anaphylaxis is a very rare side-effect of most

vaccines. It is essential that we distinguish

between reports of anaphylaxis and less serious

allergic reactions or psychogenic events. The

‘Green Book’ gives further guidance on this. If

you suspect a true case of anaphylaxis, please

report it as such via the Yellow Card Scheme. We

may need to contact you for confirmation. When

reporting less severe allergic reactions please

report only as ‘allergic reaction’ or other

relevant description. Any signs or symptoms of

anaphylaxis or other allergic reactions should be

reported only as 'additional information' on the Yellow Card.

If you require further information on the role of

the MHRA and the Yellow Card Scheme, please visit

<http://www.mhra.gov.uk/>www.mhra.gov.uk. Further

information on the vaccine can be found at

<http://www.mhra.gov.uk/HPVvaccine>www.mhra.gov.uk/HPVvaccine.

Remember, every Yellow Card report matters. Thank

you for your help in monitoring the safety of this important new vaccine.

Yours faithfully,

[]

Professor Kent Woods, Chief

Executive

--------------------------------------------------------

Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

Vaccines - http://www.wellwithin1.com/vaccine.htm

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