FOI release

Freedom of Information request on the adverse reactions for shoulder injury relating to vaccine administration (FOI 22/714)

Published 21 December 2023

FOI 22/714

21st June 2022

Dear

Thank you for your enquiry dated the 21st May where you requested information regarding suspected adverse reaction reports of shoulder injury related to vaccine administration (SIRVA) in all patient’s, year to date for 2022, broken down by patient vaccine type and region/area/location if possible.

In response to your request, I am pleased to provide you with Table 1 which shows the number of UK spontaneous suspect Adverse Reaction reports of SIRVA reported in 2022 broken down by reported vaccination and location of reporter, received up to and including 25th May 2022. Please also see Table 2 which shows the number of UK spontaneous suspect adverse reaction reports of SIRVA broken down by year, received up to and including 25th May 2022. Where less than 5 reports have been received for a specific vaccination or location an asterisk has been used to conceal this number in order to comply with data protection laws. Please note when interpreting this data that the number of reports received should not be used as a basis for determining incidence. The accuracy of the data provided relies on the postcode being provided by the reporter on the original Yellow Card. If the postcode is incorrectly provided, the Yellow Card will not be included in this analysis. Furthermore, if the reporter has only provided their email address, that report will not be included with a known location.

Table 1. UK spontaneous suspected Adverse Reaction reports of ‘shoulder injury related to vaccine administration’ first reported in 2022, received up to and including 25th May 2022, broken down by reported vaccination and reporter location

Vaccine	England	Northern Ireland	Scotland	Unknown	Wales
COVID-19 PFIZER/ BIONTECH VACCINE	19	*	4
COVID-19 VACCINE ASTRAZENECA	14		*		*
COVID-19 VACCINE MODERNA	6		*
FLU VACCINE	6		*	*
PNEUMOCOCCAL POLYSACCHARIDE VACCINE	*
SINOVAC-CORONAVAC COVID-19 VACCINE	*
VARICELLA ZOSTER VACCINE	*

Table 2. UK spontaneous suspected Adverse Reaction reports of ‘shoulder injury related to vaccine administration’ received up to and including 25th May 2022, broken down by year of initial date received by the MHRA

Year	Yellow Card Reports
2018	3
2019	2
2020	9
2021	173
2022	61
Total	248

When considering the provided spontaneous Adverse Drug Reaction (ADR) data, 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 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 note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time. For these reasons the enclosed data should not be used as a basis for determining incidence of side effects.

You will note that a number of reports relate to COVID-19 vaccinations and may be interested to read our weekly report covering adverse reactions to approved COVID-19 vaccines which can be found here Coronavirus vaccine - weekly summary of Yellow Card reporting - GOV.UK (www.gov.uk). Any emerging evidence relating to possible risks associated with vaccines and medicines is continuously reviewed and, if appropriate, regulatory action would be taken.

The number of cases of SIRVA reported in association with the COVID-19 vaccinations should be viewed in the context of the total number of reports received for these vaccines. As described our weekly summary of COVID-19 vaccine ARD reports, which includes data up to and including 25th May 2022 the MHRA has received a total of 245,400 UK Yellow Cards reporting suspected reactions to COVID-19 vaccine AstraZeneca, 171,109 to COVID-19 vaccine mRNA Pfizer/BioNTech, 39,055 to COVID-19 Vaccine Moderna and 1,720 have been reported where the brand of the vaccine was not specified.

As you will be aware there is high public awareness of the Yellow Card scheme with respect to the COVID-19 vaccines and encouragement of reporting of all events. The leaflets provided to UK recipients of the COVID-19 vaccines contain information on how suspected side effects can be reported to the MHRA and encourages reporting of any side effects through the Yellow Card scheme. Information on Yellow Card reporting has been included in NHS training materials, as well as the materials available to individuals both before and after vaccination.

The MHRA have also optimised website search functionality and worked with media outlets to encourage them to carry messages about reporting of side effects. We have run targeted social media campaigns and encouraged anyone seeing this to report through the Coronavirus Yellow Card site if they have not already done so.

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