Details of Adverse Effects of Gardasil HPV Vaccine
Caron Ryalls made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency
Dear Medicines and Healthcare products Regulatory Agency,
Please provide the number of Adverse Drug Reaction (ADR) reports relating to Gardasil HPV vaccine from September 1st 2012.
Please provide a list, frequency of reporting and details of side effects experienced within these ADR reports for Gardasil, from September 1st 2012.
As the Cervarix HPV vaccine, previously used in the UK, is a different vaccine to Gardasil with different active ingredients, it is important to look at the ADRs associated with this vaccine separately (particularly as Gardasil carries the Black Triangle symbol and so is under intensive and separate surveillance). Cervarix was being used in the UK until summer 2012, so it is expected that there will still be reports of ADRs being submitted to MHRA.
Please therefore provide, separately, the number of ADR reports relating to Cervarix HPV vaccine from September 1st 2012.
Please also provide a list, frequency of reporting and details of all side effects experienced within these ADR reports for Cervarix, from September 1st 2012.
Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:
The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:
Clinical Trials of medicines:
Clinical Trials of medical devices:
Manufacturer’s and wholesale dealer’s licences:
Registration of medical devices, opticians and dental laboratories:
Reporting a side effect to a medicine:
Reporting a counterfeit medical product:
Buying medicines over the internet:
If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.
Medicines and Healthcare products Regulatory Agency
Please note this is an automated reply; please do not respond to this
This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.
If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.
For more information on the Department of Healths email policy, click
Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.
Our Ref: FOI 12/471
Dear Caron Ryalls,
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
Thank you for your enquiry which we received on 29th November 2012.
I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.
If you need to contact us again about this request, please quote the reference number above.
Tel: 020 3080 6000
Dear Ms Ryalls,
Please find attached response to your below FOI request.
Pharmacovigilance Information Unit
Vigilance, Intelligence and Research Group