Yellow Card Reports for Vaccines

Steve Hinks made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was successful.

Dear Medicines and Healthcare products Regulatory Agency,

In July 2013 Earl Howe reported to the House of Lords that there had been 7230 Yellow Card reports received by the MHRA for adverse reactions to HPV vaccines since September 2008 of which 1287 were considered serious. He also reported that 6.75 million doses had been given. Since each girl receives 3 doses presumably 2.25 million girls have been immunised which works out at 21 serious adverse reactions per 100,000 girls vaccinated.

Please provide comparable information for other vaccines during this period i.e. how many Yellow Card Reports, of which how many considered serious. How many doses given and how many recipients. Plus the quantity of serious adverse events per 100,000 recipients.

Yours faithfully,

Steve Hinks

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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[3]http://www.mhra.gov.uk/Howweregulate/Dev...
 
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[4]http://www.mhra.gov.uk/Howweregulate/Med...
 
Registration of medical devices, opticians and dental laboratories:

[5]http://www.mhra.gov.uk/Howweregulate/Dev...
 
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[6]http://www.mhra.gov.uk/Safetyinformation...
 
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[7]http://www.mhra.gov.uk/Safetyinformation...
 
Does my product need a licence?:

[8]http://www.mhra.gov.uk/Howweregulate/Med...
 
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[9]http://www.mhra.gov.uk/Safetyinformation...
 
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[10]http://www.mhra.gov.uk/Safetyinformation...
 
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Kind regards
 
Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency
 
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Communications via the GSi may be automatically logged, monitored and/or
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References

Visible links
1. http://www.mhra.gov.uk/Contactus/Custome...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 13/498

Dear Steve Hinks,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 28th October 2013.

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.

Yours Sincerely

Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency
Tel: 020 3080 6000

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Pharmacovigilanceservice, Medicines and Healthcare products Regulatory Agency

2 Attachments

Dear Mr Hicks

Please find attached documents for your attention.

Yours sincerely

Maxine

PV Service Team
Vigilance and Risk Management of Medicines
MHRA
[email address]

Your views are important to us. If you'd like to leave feedback around the service you have experienced, please follow the link below:

https://www.surveymonkey.com/s/PVService

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
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Dear Medicines and Healthcare products Regulatory Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request the full information requested. I have received an excellent report for the last 3 years Yellow Card reports but my request was also for the previous years since HPV vaccination was introduced (I think 2008). Similar information for the earlier period would be most appreciated.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/y...

Yours faithfully,

Steve Hinks

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare Products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
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 18 working days. Further information on how we handle different
requests can be found on our website at the link below:
 
[1]http://www.mhra.gov.uk/Contactus/Custome...
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical Trials of medicines:
 
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:
 
[3]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Manufacturer’s and wholesale dealer’s licences:

[4]http://www.mhra.gov.uk/Howweregulate/Med...
 
Registration of medical devices, opticians and dental laboratories:

[5]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Reporting a side effect to a medicine:

[6]http://www.mhra.gov.uk/Safetyinformation...
 
Reporting an adverse incident involving a medical device:
 
[7]http://www.mhra.gov.uk/Safetyinformation...
 
Does my product need a licence?:

[8]http://www.mhra.gov.uk/Howweregulate/Med...
 
Reporting a counterfeit medical product:
 
[9]http://www.mhra.gov.uk/Safetyinformation...
 
Buying medicines over the internet:
 
[10]http://www.mhra.gov.uk/Safetyinformation...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency
 
For a short period in December we will be running a survey of the service
offered by our Customer Services team. We endeavour to provide a friendly
and informative customer focused service in line with the standards
outlined below. The purpose of the survey is to establish how our
customers feel about the service, and where they’d like to see
improvements made. A link to the survey will be posted on our Customer
Services homepage in early December, and if you have used our service we
would like to receive your views. Summary results from the survey will be
posted on this page in late 2014.
 
Please note this is an automated reply; please do not respond to this
message.
 
 

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

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Custome...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

3 Attachments

Dear Mr Hinks,
       
Thank you for your email.

Attached is the response to your FOI request.

       
Kind Regards,

Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency

Tel: 020 3080 6000

 

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

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

Wilson, Stephen, Medicines and Healthcare products Regulatory Agency

Dear Mr Hinks

 

I am writing to you from the MHRA’s FOI team. Amongst our responsibilities
in this area is that of conducting internal reviews. When you wrote in on
26 November requesting an internal review of your request number 13/498,
it was passed to me for action.

 

I contacted the team responsible for the original reply and was expecting
them to let me know why you had not been provided with all you had
requested, and how they intended to address this issue. However, I have
since discovered that they have replied to you directly, instead of via
the FOI team as is the usual process. Consequently, a formal internal
review was not conducted in respect of your request.

 

This communication is to ask you if that reply was satisfactory and
provided you with what you required? If it was not satisfactory, or if you
would still like to proceed with a formal internal review of the way in
which your request was handled, please let me know and I will be happy to
either pursue the matter on your behalf, or revive the internal review
process.

 

Kind regards, and compliments of the season.

 

Mr S Wilson

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Dear Mr Wilson,
Thank you. Initially I only received a partial reply but when I requested it a full answer was given

Yours sincerely,

Steve Hinks