FOI release

Freedom of Information request on shoulder injuries reported as an adverse reaction following a COVID-19 vaccine administration (FOI 22/703)

Published 27 March 2023

FOI 22/703

10th June 2022

Dear

Incidence rates of shoulder injury related to vaccine administration (SIRVA)

Thank you for your email dated 14th May 2022, where you requested the following information:

Please can you provide me with up-to-date incidence rates of shoulder injury related to COVID-19 vaccine administration (SIRVA) in adults in UK?

I have not seen any mention of these on the COVID reporting weekly bulletins, but I am aware from previous FOI requests that these have been Yellow Carded.

The MHRA and CHM have been continually monitoring the safety profile of COVID-19 vaccines licensed in the UK. This monitoring process involves the collection of information about suspected adverse reactions in patients (through the Yellow Card scheme) and assessment of any new suspicions of harmful effects. The Yellow Card scheme allows anybody to submit reports of suspected side effects, including patients and healthcare professionals alike. We also work closely with our public health partners in reviewing the effectiveness and impact of the vaccines to ensure the benefits continue to outweigh any possible side effects, and, if appropriate, regulatory action would be taken. This scheme is one way the MHRA carries out COVID-19 vaccine safety surveillance, and you can find out more information on our proactive pharmacovigilance strategy and how we monitor safety here.

The MHRA do not hold the incidence rates of SIRVA in adults in the UK. As explained above, the MHRA collect reports of suspected side effects via the Yellow Card scheme. The number of Yellow Card reports received by the MHRA of SIRVA associated with a COVID-19 vaccine does not directly equate to the number of people who may have experienced adverse reactions and therefore cannot be used to determine the incidence of reactions. ADR reporting rates are influenced by many aspects, including the extent of use.

Whilst we cannot provide the incidence rates requested, we can provide the numbers of Adverse Drug Reaction (ADR) reports received. As you are aware, we publish a weekly summary of Yellow Card reporting related to COVID-19 vaccines, which can be found here: Coronavirus vaccine - weekly summary of Yellow Card reporting - GOV.UK (www.gov.uk). The weekly reports summarise adverse reaction information associated with the COVID-19 vaccines received via the Yellow Card scheme, and within Annex 1 of the report, you will find four Vaccine Analysis Prints (VAPs). Each VAP lists all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme for a COVID-19 vaccine up to and including 25th May 2022. There is also a VAP for ADR reports where the brand of the COVID-19 vaccine is unspecified. Although SIRVA is not included as a specific safety topic in the summary report, these VAPs include the number of reports the Yellow Card scheme has received for SIRVA. Please see below table showing a breakdown of the total number of Yellow Card reports received concerning SIRVA received by the MHRA per COVID-19 vaccination.

Table 1: Total number of UK spontaneous suspected adverse reaction reports of SIRVA associated with e each COVID-19 vaccine, up to and including 25th May 2022.

COVID-19 Vaccination	Total Number of ADR reports
COVID-19 mRNA Vaccine BioNTech/ Pfizer	71
COVID-19 Vaccine AstraZeneca	117
COVID-19 Vaccine Moderna	15
COVID-19 Brand Unspecified	2

The figures provided in Table 1 is per vaccine brand, and one Yellow Card can include more than one COVID-19 vaccine brand. Therefore, the sum of the number of reports in Table 1 will not equate to the total number of Yellow Cards reporting SIRVA.

When considering the data provided in this response and the VAPs, it is important to be aware of the following points:

• Please note that the data provided only includes reports where the ADR was specifically reported as SIRVA. Reports that only state shoulder pain, stiffness or other shoulder-related reactions have not been included in the table.

• 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 vaccinations are given in the UK alone, and when any vaccine is administered to large numbers of people, some recipients will inevitably experience illness following vaccination. The fact that symptoms occur after use of a vaccine or medicine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. 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 or compare the safety profile of different vaccines. 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.

The number of SIRVA cases associated with the COVID-19 vaccinations should be viewed in the context of the total number of reports received for these vaccines. As described in the most recent weekly summary of COVID-19 vaccine ADR reports, the MHRA has received a total of 245,400 UK Yellow Cards for the COVID-19 vaccine AstraZeneca, 171,109 UK Yellow Cards for the COVID-19 vaccine mRNA Pfizer/BioNTech, 39,055 UK Yellow Cards for the COVID-19 vaccine Moderna, and

1720 UK Yellow Cards for a COVID-19 vaccine where the brand was not specified, up to and including 25th May 2022.

It is important to state that for the vast majority of recipients, the benefits of receiving a dose of COVID-19 vaccination continues to outweigh the potential risks, both in terms of possible vaccine-related side-effects and the impact of potentially waning immunity to COVID-19.

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 this response’s date and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division