FOI release

Freedom of Information request on data collected via the yellow card scheme (FOI 21/1028)

Published 25 February 2022

24th September 2021

FOI 21/1028

Dear

Thank you for your email dated 08/09/2021 where you asked for the following information under the Freedom of Information Act:

1. Do you collect data on ages, as part of the Yellow Card reporting scheme?

2. If you do, why is this data not yet publicly available, when I was told by your staff back in at least May 2021 that it would shortly be available to the public online?
3. If you do not, then how was Dr Raine able to assure me in a signed letter, dated 14th June, that all reports of Paroxysmal Extreme Pain Disorder (11 reports at that time) affected only adults and not babies?
4. Those reports of Paroxysmal Extreme Pain Disorder (currently 13 reports) are still listed under Congenital Disorders. Why are they listed under Congenital Disorders, if in fact they only relate to adults and not babies?

The MHRA collects information on patient age as part of the Yellow Card scheme. However, age is not a mandatory field and as such the age of the patient is not always provided by the reporter. As previously stated, it remains our intention to seek permission to publish interactive Drug Analysis Prints (iDAPs) for vaccines which would enable stratification of the data by a number of factors, including age. However, details of the deliberations on this matter are withheld under Section 35 of the FOI Act. Section 35 of the FOI Act protects the internal deliberative process as it relates to Government policy making. In other words, the exemption is intended to ensure that the possibility of public exposure does not deter from full, candid and proper deliberation of policy formulation and development, including the exploration of all options, the keeping of detailed records and the taking of difficult decisions. Section 35 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information.

I can confirm, up to and including 8th September 2021, we have received 12 spontaneous ADR reports associated with paroxysmal extreme pain disorder with the COVID-19 AstraZeneca vaccine. As stated in our previous correspondence, we have reviewed and fully evaluated all Yellow Card reports received. Upon assessment of these reports, all were found to be related to adult patients that described body pain including arm pain, muscle and joint pain or general body aches, including reports of ‘extreme pain’, rather than medically confirmed cases of paroxysmal extreme pain disorder. All of these reports were submitted by patients who have selected the reaction term they believe best describes their experience.

The MHRA uses the Medical Dictionary for Regulatory Activities (MedDRA) to capture reactions within our Adverse Drug Reaction (ADR) reports. This dictionary uses a hierarchical structure with the most specific terms at the bottom which in turn are grouped into larger groups of related terms. The term paroxysmal extreme pain disorder refers specifically to a congenital disorder of this name and as such this term maps into the congenital, familial and genetic disorders system organ class (SOC). When using the form, reporters can choose terms from the lowest level of the hierarchy to describe their reaction but they may not necessarily know that this term maps into the congenital, familial and genetic disorders system organ class (SOC) when selecting it from the list; they are only choosing the one they feel best describes their experience.

As previously stated, if a mis-selection is noted in a Yellow Card report we can follow-up with the reporter for confirmation if necessary, where permission allows. We routinely review and update cases to ensure information is accurately captured on our database so published numbers may change over time.

I hope the information provided is helpful, but 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 of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division