COVID-19 Vaccines Yellow Card
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!
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 firstname.lastname@example.org
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.
- Details about the patient and their doctor.
- 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.
- Details of the side effect experienced such as nausea, dizziness or something more serious. (You can report multiple side effects)
- How long the suspected side effect lasted for and what the outcome was (if known).
- 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.