Yellow card scheme statistics

Miss G made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

Response to this request is long overdue. By law, under all circumstances, Medicines and Healthcare Products Regulatory Agency should have responded by now (details). You can complain by requesting an internal review.

Dear Medicines and Healthcare products Regulatory Agency,

Under the freedom of information please provide the following information.

Since the date of the 1st pfzier vaccine being administered until 15th Jan 2021, how many yellow card scheme reports of ADR have been reported and registered to MHRA?

Please provide
1. The total number of Yellow card scheme ADR reports MHRA has received during this period in regards to the pfzier vaccine?
2. A breakdown of these totals for each ADR received by MHRA during this period, by category, ie. Total number persons who reported vomiting after receiving the vaccine,
3. Total number of people who have died within 28 days of receiving the Pfzier vaccine?
4. A breakdown of where these yellow card scheme ADR are being reported from, and the total for each region ie. England, Scotland, Wales and NI

Yours faithfully,

Miss G Simpson

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 

 

Please note that we may not respond if your query: 

 

• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 

 

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 

 

The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here. 

References

Visible links
1. https://www.gov.uk/government/collection...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/056

Dear Miss G Simpson,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 18 January 2021.

I confirm that your request is now 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.

Kind Regards,


MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 21/056

Dear Miss G Simpson,

Thank you for your email of 17th January where you have asked "1. The total number of Yellow card scheme ADR reports MHRA has received during this period in regards to the pfzier vaccine?
2. A breakdown of these totals for each ADR received by MHRA during this period, by category, ie. Total number persons who reported vomiting after receiving the vaccine, 3. Total number of people who have died within 28 days of receiving the Pfzier vaccine?
4. A breakdown of where these yellow card scheme ADR are being reported from, and the total for each region ie. England, Scotland, Wales and NI

We confirm we have now published the data and this is available to view at the following link of our website page below.

https://www.gov.uk/government/publicatio...

If you have a query about the information provided, please reply to this email.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [MHRA request email].

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Kind Regards,

MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade
Canary Wharf
London E14 4PU
Telephone 020 3080 6000

show quoted sections

Dear MHRA Customer Services,

Thanks for your reply.

Unfortunately the information available in this link does not answer all my information requests, therefore i ask again if you can please provide the following information

3. Total number of people who have died within 28 days of receiving the Pfzier vaccine?

4. A breakdown of where these yellow card scheme ADR are being reported from, and the total for each region ie. England, Scotland, Wales and NI

In addition, the pfzier analysis report advices a total number of drug reactions, as 49472 but only 16756 reported drug reactions.

Where does MHRA obtain the data for the unreported 32716 ADR's recorded in this report, if not reported?

Yours sincerely,

Miss G Simpson

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/151

Dear Miss G Simpson,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 6 February 2021.

I confirm that your request is now 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.

Kind Regards,


MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Miss Simpson,

Please find attached the response to your FOI request.

Kind regards,

FOI Team 
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
 

show quoted sections