About this site
The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive Agency of the Department of Health and Social Care that acts on behalf of the Ministers to protect and promote public health and patient safety, by ensuring that medicines and medical devices meet appropriate standards of safety, quality and efficacy.
The MHRA runs the Yellow Card scheme which collects and monitors information on suspected safety concerns or incidents involving: medicines, vaccines, medical devices, and e-cigarettes. The scheme relies on voluntary reporting of suspected safety concerns or incidents by healthcare professionals and members of the public (patients, users, or carers).
The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation. Further information about the Yellow Card scheme, including its contribution to identifying safety issues can be found on the Yellow Card website.
The MHRA is responding to the coronavirus pandemic and providing a dedicated coronavirus Yellow Card site for healthcare professionals and patients to report the following related to coronavirus treatment:
suspected side effects to medicines
suspected side effects of any current and future COVID-19 vaccines
incidents involving medical devices
You can order free COVID-19 test kits by clicking here: https://www.gov.uk/get-coronavirus-test
You can register your COVID-19 test results by clicking here: https://www.gov.uk/report-covid19-result
Why should I report?
Reporting suspected side effects or faulty medical devices helps identify issues which might not have been previously known.
A number of vaccines have been developed against coronavirus (COVID-19) and are currently being rolled out. Several treatments authorised for other diseases, including severe respiratory illnesses, are being used in patients with COVID-19. This also includes medicines and medical devices used to treat the symptoms of coronavirus, provide supportive care, or to suppress virus reproduction in some cases.
We still do not know how COVID-19 interacts and behaves with medicines or medical devices used for existing conditions. By reporting through this site, patients and healthcare professionals can help gather valuable evidence to inform decisions on the safe and effective use of medicines, vaccines and medical devices as the pandemic evolves.
If a medicine or a medical device is used in a different way or for a different purpose, or it is new, or brought to market faster to aid coronavirus treatment, it is especially important that it is monitored closely and any suspected incidents are quickly reported.
What should I report?
Report suspected side effects to medicines or COVID-19 vaccines or incidents involving medical devices, including faulty equipment, used for the treatment of coronavirus.
When reporting, patients and healthcare professionals are encouraged to provide as much information as possible.
Where should I report?
Please report to the dedicated Coronavirus Yellow Card reporting site.
It is important that sponsors continue to report via the established routes for clinical trials and not via the Yellow Card scheme.
Suspected side effects
When reporting side effects to vaccines the following information should be provided, where available:
Information on the person who has experienced the side effect
Whether the side effect is related to the first or second dose of the vaccine
The date of the vaccination
The name and batch number of the vaccine suspected to have caused the side effects
A description of the side effects
Any other medicines being taken around the same time (including non-prescription and herbal remedies)
Any other health condition that the person who experienced the side effect may have
More information on the possible side effects of Covid-19 vaccinations is available on the NHS website.
When reporting side effects to medicines used to treat COVID-19 the following information should be provided, where available:
Information on the person who has experienced the side effect
Whether the COVID-19 infection has been confirmed through testing
The name of the medicine suspected to have caused the side effects
A description of the side effects
Any other medicines being taken around the same time (including non-prescription and herbal remedies)
Any other health condition that the person who experienced the side effect may have
Details on what we do with reports of suspected side effects can be seen in guide to how we monitor the safety of medicines.
Medical device incidents
When reporting adverse incidents to medical devices at least the following information should be provided:
Information about the person affected by the adverse medical device incident
Information about the medical device, including the type and where you got it from
A description of the incident, including whether there was an injury
Whether the COVID-19 infection has been confirmed through testing
To report on any other medicines or medical devices unrelated to COVID-19 please report via www.mhra.gov.uk/yellowcard
Defective medicines or vaccines
During the manufacture or distribution of a medicine or vaccine, an error or incident may occur whereby the finished product does not conform to its specification or for some other reason is defective (e.g. presence of a contaminant).
A defect may impair the effect of the product and present undesirable side effects, it should not be confused with an Adverse Drug Reaction where the product conforms to its specification. Advice from a Pharmacist or GP can help to differentiate between adverse drug reactions and defective medicinal products.
For suspected defective medicines or vaccines, report as usual on the Yellow Card website.
For information on the defective process for vaccines please see the defective vaccines reporting process