COVID-19 Vaccines Yellow Card

Campaign Start:

15/03/2021

Campaign End:

Background

Following the declaration of a global pandemic regarding COVID-19 in early 2020, vaccine manufacturers across the globe have raced to develop vaccine products.

In December 2020, the Medicine and Healthcare Product Regulatory Agency (MHRA) gave temporary emergency use authorisation for the Pfizer/BionTech and AstraZeneca vaccine products so that they could be administered to the most vulnerable in society.

This temporary authorisation is not “approval” and is given where the MHRA believe that in a public health situation, the benefits of the use of the products before full testing has been completed outweigh the risks of doing so.

The continuation of the temporary authorisation depends on whether that initial belief – that the benefits of early use outweigh the risks – continues to be valid.

A key factor in the ability of the MHRA to be able to assess the situation is the availability of as much data as possible about any adverse reactions to the vaccines, no matter how mild.

The Importance of Reporting

Reporting adverse reactions helps to educate Health Care Professionals (HCPs) and the public on the safe use of medicines, improve medicines and to prevent future harm to patients.

The MHRA Yellow Card scheme, is the official UK Government system for collecting and monitoring information on safety, suspected side effects or adverse events involving all medicines available on the UK market including COVID-19 tests and vaccines.

Yellow Card reports have helped identify numerous important safety issues, many of which were not known about until the information was received.

Under-reporting is a common problem. Although health care professionals and carers use it regularly, the scheme relies heavily on voluntary contributions and is not very well known. Only about 10% of all suspected side effects are reported.

But anyone can submit a report – and that includes you! So, if a family member, friend, neighbour, student, teacher, parent, or yourself, have had a side effect no matter how small, please report it, as it will make medicines safer for everyone and help prevent future harm.

As the MHRA says – Every Report Counts!

Action Needed

How To Report A Side Effect or Adverse Reaction

There are 4 ways to report a COVID-19 test or vaccine side effect to the Yellow Card Scheme in the  UK.

1. Use the Online Yellow Card Form

You can click on the “Take Action” button below or visit https://coronavirus-yellowcard.mhra.gov.uk/

2. Use a Yellow Card form from a pharmacy or GP surgery

All pharmacies and GP’s surgeries have Yellow Card scheme forms available to pick up.  The form contains details of where to send it once you have filled it in.

3. Call the Yellow Card Call Centre

If you prefer to speak to someone in person, you can call the Yellow Card scheme helpline on 0800 731 6789

4. Send an E-mail

You can email the scheme to report a reaction at yellowcard@mhra.gov.uk 

What information should be included in a Yellow Card report?

As much information as possible should be supplied on the Yellow Card report to enable a full assessment by the MHRA, but you should not be put off sending in a Yellow Card report if all the information is not available at the time of reporting. It only takes about 5 minutes to do.

  1. Details about the patient and their doctor.
  2. Details about the suspected drug(s)/vaccine(s) they were taking, including self-medication and complementary remedies, any medical conditions or allergies, if pregnant or breastfeeding etc.
  3. Details of the side effect experienced such as nausea, dizziness or something more serious. (You can report multiple side effects)
  4. How long the suspected side effect lasted for and what the outcome was (if known).
  5. Details of the individual completing the report i.e. their contact details

The MHRA may contact the individual completing the report for further details.

What Happens To This Information?

  • With your permission a copy of the report will be sent to your GP. (You can opt out)
  • You can view a summary of all the information you’ve provided and save a copy. (online)

If You Need Help

If you need help completing the form, you can call the Yellow Card helpline on freephone 0800 731 6789 or ask a healthcare professional.

TAKE ACTION

Essential Context for Understanding this report

These reports contain a complete listing of all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme for COVID-19 vaccines. This includes all reports received from healthcare professionals, members of the public, and pharmaceutical companies.

This information does not represent an overview of the potential side effects associated with the vaccines. A list of the recognised adverse effects of the COVID-19 vaccines is provided in the information for healthcare professionals and the recipient information here. Conclusions on the safety and risks of the vaccines cannot be made on the data shown in the report alone. When viewing the report, you should remember that:

  • Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the vaccine may have caused the adverse reaction. The existence of an adverse reaction report does not necessarily mean that the vaccine has caused the reaction.

  • It may be difficult to tell the difference between something that has occurred naturally and an adverse reaction. Sometimes reactions can be part of the condition being treated rather than being caused by the vaccine.

  • Many factors have to be considered when assessing whether a vaccine has caused a reported adverse reaction. When monitoring the safety of medicines and vaccines, MHRA staff carry out careful analysis of these factors.

  • It is not possible to compare the safety of different vaccines by comparing the numbers presented in the vaccine reports. Reporting rates can be influenced by many factors including the seriousness of the adverse reactions, their ease of recognition and the extent of use of a particular vaccine. Reporting can also be stimulated by promotion and publicity about a product.

For a vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people receive vaccinations without having any serious side effects.

Risks and benefits of medicines

For a medicine to be considered safe, the expected benefits of the medicine will be greater than the risk of suffering harmful reactions. It is important to note that most people take medicines without suffering any serious side effects.

All medicines can cause reactions. The patient information leaflet accompanying the medicine, or available from your pharmacist, lists the known side effects associated with the medicine. Healthcare professionals such as doctors and pharmacists can also provide this information. Information on side effects of medicines can be found on the NHS website.

Monitoring the safety of medicines and vaccines

Information collected through the Yellow Card scheme is an important tool in helping the MHRA and CHM monitor the safety of medicines. Yellow Card reports of suspected adverse reactions are evaluated, together with additional sources of evidence such as worldwide literature, in order to identify previously unidentified hazards or side effects.

If a new side effect is identified, information is carefully considered in context of the overall side effect profile for the medicine or vaccine, and how it compares with other medicines used to treat the same condition.

The MHRA will take action, if necessary, to ensure that the product is used in a way that minimises risk, while maximising patient benefit. Such changes may include, for example, restricting the indication, or special warnings and precautions. Rarely, a drug may need to be withdrawn from the market if the risk of side effects is considered to outweigh the benefits of treatment. Please see our How we monitor the safety of medicines section for further information.

Use of Yellow Card data for publication

If you wish to copy or circulate the information contained within a report to anyone else, please ensure that a copy of these guidelines is also provided.

The MHRA and CHM encourage the use of data from the Yellow Card scheme in research and for publication, but wish to ensure that the limitations of interpretation of the data are made clear.

If you propose to publish information based on Yellow Card data, the MHRA is most willing to provide advice on how the Yellow Card information might be best used and presented. The MHRA is also willing to provide feedback on manuscripts prior to publication. Please write to the Deputy Director, Safety and Surveillance Group by email.