FOI release

Freedom of Information request on incidence rates of shoulder injury related to COVID-19 vaccine administration (FOI 21/748)

Published 29 December 2021

30th July 2021

FOI 21/748

Dear

Thank you for your FOI request dated 30th June 2021, where you asked for incidence rates of shoulder injury related to COVID-19 vaccine administration (SIRVA).

The Yellow Card scheme is the UK system for collecting and monitoring information on suspected adverse drug reactions (ADRs). The Scheme is run by the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the Commission on Human Medicines (CHM) and is a voluntary scheme and therefore it is subject to variable levels of reporting. Reporting rates to the Yellow Card scheme are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and can be stimulated by promotion and publicity about a drug or vaccine. Taking these factors into consideration the number of reports received should not be used as a basis for determining incidence. Please bear this in mind when interpreting the data provided here.

We can confirm that we have a total of 39 UK spontaneous suspected Adverse Reaction reports of ‘shoulder injury related to vaccine administration’, up to, and including, 21st May 2021. Please note that one report can contain multiple suspected drugs or vaccinations; the table below relates to reports per vaccine and so the sum should not be used to calculate total reports.

Table 1. MHRA, UK spontaneous suspected Adverse Reaction reports of ‘shoulder injury related to vaccine administration’, up to, and including, 21st May 2021 for COVID-19 vaccines

Vaccination	Yellow Card reports
COVID-19 vaccine Pfizer	7
COVID-19 vaccine AstraZeneca	32

When considering the table above, it is important to be aware of the following points:

• The MHRA code all reported reactions using a medical dictionary called MedDRA, this maps more specific Lower Level Terms (LLTs) to Preferred Terms (PTs), Higher Level Terms (HLTs), Higher Level Group Terms (HLGTs) and System Organ Classes (SOCs). Please note that the data provided only includes reports where the ADR was specifically reported as ‘should injury related to vaccine administration’ or SIRVA, i.e. any ADR reports that simply relate to shoulder pain following administration of a vaccine will not be included in the cases provided.
• A reported reaction does not necessarily mean it has been caused by the vaccine, only that the reporter had a suspicion it may have. Each year, millions of doses of routine vaccines are given in the UK alone, and when any vaccine is administered to very large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms or events occur after use of a vaccine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the vaccine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
• It is also important to reiterate that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions.

Therefore Yellow Card data cannot be used to determine the incidence of a reaction or to compare the side effect profiles of different medicines or vaccines.

You may be interested to read our weekly report covering adverse reactions to approved COVID-19 vaccines. Any emerging evidence relating to possible risks associated with vaccines and medicines is continuously reviewed and, if appropriate, regulatory action would be taken.

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