FOI release

Freedom of Information request on suspected reports of shoulder injury related to vaccine administration in the adult population (FOI 21-605)

Published 13 August 2021

30th June 2021 FOI 21/605

Dear

Thank you for your FOI request dated 1st June 2021, where you asked follow-up questions in response to your previous FOI 21/463.

In response to FOI request 21/463 we provided data relating to all UK spontaneous suspected reports of “shoulder injury related to vaccine administration” (SIRVA) in all patient ages. It has since been noted that your request specified that you were interested in reports relating to the adult population only. Please accept my apologies for this error and any inconvenience that it may have caused.

I can confirm that the MHRA has received a total of 71 UK spontaneous suspected Adverse Reaction reports of SIRVA in patients over the age of 18, up to and including 25/06/2021.

As requested, please see below for breakdowns of the reported vaccination (table 1), patient sex (table 2) and year of initial report (table 3) in these cases. Please note that one report can contain multiple suspected drugs or vaccinations; table 1 below relates to reports per vaccine and so the sum should not be used to calculate total reports. As previously mentioned, 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.

Table 1. UK spontaneous suspected Adverse Reaction reports of ‘shoulder injury related to vaccine administration’ in adult patients, up to, and including, 25th June 2021 broken down by reported vaccination

Vaccination	Yellow Card reports
COVID-19 vaccine AstraZeneca	42
COVID-19 vaccine mRNA Pfizer/BioNTech	13
Influenza vaccine	13
Pneumococcal Polysaccharide Vaccine	2
Diphtheria, tetanus and poliomyelitis vaccine	1
Shingles vaccine	1

Table 2. UK spontaneous suspected Adverse Reaction reports of ‘shoulder injury related to vaccine administration’ in adult patients, up to, and including, 25th June 2021 broken down by patient sex

Patient Sex	Yellow Card reports
Female	55
Male	16
Total	71

Table 3. UK spontaneous suspected Adverse Reaction reports of ‘shoulder injury related to vaccine administration’ in adult patients, up to, and including, 25th June 2021 broken down by year initial report received by MHRA

Year	Yellow Card reports
2018	3
2019	2
2020	9
2021	57
Total	71

When considering the tables 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 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. 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 in the most recent weekly summary of COVID-19 vaccine ARD reports, the MHRA has received a total of 205,221 UK Yellow Cards reporting suspected reactions to COVID-19 vaccine AstraZeneca and 73,944 UK Yellow Cards reporting suspected reactions to COVID-19 vaccine mRNA Pfizer/BioNTech, up to and including 16th June 2021.

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 are running a targeted social media campaign currently and would encourage anyone seeing this who has not already done so to report through the Coronavirus Yellow Card site. The Coronavirus Yellow Card site has been designed to enable both self-reporting, and for people to report on behalf of others. Where people do not have access to the internet, they can request a family member or carer to report on their behalf, or alternatively discuss their experience with a healthcare professional, who can report for them.

Furthermore, to raise awareness of the site and Yellow Card reporting, the MHRA have also released a Drug Safety Update and a press release informing healthcare professionals and members of the public that reporting to the new site will enable the MHRA to rapidly identify new and emerging side effects. The general public have also been encouraged to report any suspected side effects to the vaccine to the MHRA via a Yellow Card on the recent televised press briefings.

To address your question around inclusion of the Yellow Card data in your thesis, the MHRA encourages the use of Yellow Card data however wishes to ensure the correct interpretation is placed upon the data. For this reason, if you wish to use this information for publication, we request that a copy of the report be sent to the MHRA for approval.

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