You should report suspected adverse reactions to:
Medicines, vaccines, herbal and homeopathic remedies, e-cigarettes, blood factors and immunoglobulins, defective and falsified medicines.
You should report all suspected adverse reactions for medicines and vaccines under additional monitoring, black triangle (▼)
For established medicines and vaccines (including over the counter) report, all serious suspected adverse reactions even if the effect is well recognised.
Serious reactions are those which are:
- fatal
- life-threatening
- disabling
- incapacitating
- have resulted in, or prolonged, hospitalisation
- considered medically significant
- suspected to have caused congenital abnormalities
However, if you are unsure of the seriousness of a reaction, please report it anyway.
Adverse effects to medical devices should be reported to the Northern Ireland Adverse Incident Centre (NIAIC).
What to include in a Yellow Card Report
You only need to include FOUR critical pieces of information in a Yellow Card report. Additional information is useful but not essential.
Suspect Medicine
Include the name of the medicine, vaccine or healthcare product suspected to have caused the rection.
For vaccines and biological medicines it is helpful to include the batch number if you have it
Suspect Reaction
Description of the suspect reaction including a diagnosis (if available)
If known include when the reaction occurred, the seriousness of the reaction, if treatment was required and the outcome, if known
ONE Patient detail
Basic information about the patient is vital in assessing Yellow Card reports.
Providing this information does not breach patient confidentiality.
Include one of
– Patient age
– Patient sex
– Patient identification number
For patient identification number you can use any number or code that will identify the patient to you but not the MHRA.
Your details
This must be completed. This allows the MHRA to acknowledge receipt of your report and contact you if further information is required
You can provide additional relevant information if known but do not delay reporting if this is not available.
Feedback to Reporters
All Yellow Card reports are acknowledged by the MHRA and are entered onto their database. If additional information is required the MHRA may contact you.
If in doubt, fill one out.
Contact the Yellow Card Centre Northern Ireland
Monday- Friday 9am- 1:30pm
028 9504 0558
YCCNorthernIreland@belfasttrust.hscni.net