Freedom of Information request on COVID-19 vaccine adverse reactions (FOI 21/896)
Published 20 January 2022
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24th August 2021
FOI 21/896
Dear
Thank you for your email.
All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.
For all COVID-19 vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as ‘flu-like’ illness, headache, chills, fatigue (tiredness), nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat. Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illness.
These types of reactions reflect the normal immune response triggered by the body to the vaccines. They are typically seen with most types of vaccine and tend to resolve within a day or two.
As with any vaccine or medicine, COVID-19 vaccines require continuous safety monitoring and that the benefits in protecting people against COVID-19 outweigh any side effects or potential risks. This is a process known as safety monitoring (pharmacovigilance). This ensures that any potential medium and long term safety issues, which it is not possible to evaluate in clinical trials are promptly and adequately evaluated. As part of our signal detection processes, all adverse reaction reports received are individually assessed and cumulative information reviewed at regular intervals. Be reassured that the MHRA is working in collaboration with partners in the health system to rapidly assess all available safety data in real time and communicate any emerging issues, as necessary.
Please note that at present there is no advice from the MHRA regarding booster vaccines and no vaccine has yet been approved for use as a booster vaccine.
Kind regards,
MHRA Customer Service Centre