Dear Medicines and Healthcare products Regulatory Agency,

I would like to know how many records you have of people claiming to have had adverse reactions to the Covid19 vaccines. I understand that you operate the yellow card scheme and you therefore hold this information.

To further clarify, I would like a tabulated collection of all the data you hold regarding reports of adverse reactions to the Covid19 vaccines. That's to say I'd like a spreadsheet containing all reports to date along with details of each report, for example the time and date of the report and the type of reaction that has been reported i.e. Allergic reaction, blood clot, death etc. A simple spreadsheet containing all of this relevant information would suffice.

Yours faithfully,

Ian Dalton

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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We will respond to you as soon as possible. 

 

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Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
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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

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

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/619
       
Dear Ian Dalton,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 3 June 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.

Please be aware that we publish FOIs replies and these are redacted and are located on our website at the following link below.
https://www.gov.uk/government/collection...
        
Kind Regards,

 
MHRA Customer Service Centre
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000

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Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

Dear Mr Dalton,

 

Thank you for your FOI request. We are regularly publishing Yellow Card
data associated with COVID-19 vaccinations. Yellow Card data for drugs is
routinely published on the Yellow Card website, with vaccine data
available on request. However, for COVID-19 vaccinations we are
proactively publishing details of adverse drug reactions received,
including MHRA assessment of the data to provide context. Please note this
data is updated weekly.

[1]https://www.gov.uk/government/publicatio...

 

We intend to publish all suspected reactions reported in association with
available COVID-19 vaccines in an interactive format as iDAPs, along with
our ADR summary that is published each week. The use of iDAPs will enable
users to view the data by categories of their choice such as age, sex and
seriousness of reports. Users will also be able to download the data
tables in CSV format. We would be happy to provide you with a link to this
when it is published.

 

 

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

 

 

 

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Dear Pharmacovigilanceservice,

I'm unsure as to why you haven't provided me with the information I requested. I'm aware of the weekly reports but that's not what I'm asking for. I'd like to request an internal review please.

Yours sincerely,

Ian Dalton

Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.
 
The Pharmacovigilance Service Team will aim to provide a response to your
query within seven working days – however where a contribution from a
specialist is required this may take longer; we endeavour to respond to
all requests within ten working days.
 
If you have not received a response within 10 working days, please feel
free to follow up via email.
 
If you are unsatisfied with the handling of your request, or for any
urgent matters, please contact the Service Team Manager Faiza Farooq on
0203 080 6511
 
All information provided is handled in line with our privacy policy, which
can be viewed on our website at
https://www.gov.uk/government/publicatio....
 
Kind Regards,
Pharmacovigilance Service Team
Vigilance and Risk Management of Medicines
MHRA
10 South Colonnade
Canary Wharf
London
E14 4PU

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 21/619

Dear Ian Dalton,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 21/619. We normally aim to respond to requests for internal review within 20 working days of receipt. However, due to high volumes of queries we are currently receiving related to COVID-19 please be aware that responses may take longer than usual.  

Kind Regards  

MHRA Customer Service Centre

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

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Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

2 Attachments

  • Attachment

    RE FOI 21 619 CSC 52876 Freedom of Information request Vaccine adverse reactions.html

    16K Download

  • Attachment

    FOI 21 619.pdf

    101K Download View as HTML

Dear Mr Dalton,

Please find the attached in response to your Internal Review 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

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