3. Serious reactions

All serious suspected reactions must be reported via the Yellow Card Scheme, regardless of whether a product is a black triangle drug or vaccine. The side-effects of an established drug may be well known but if a serious reaction occurs it should always be reported so that rare or delayed effects can be identified.
Serious reactions include those that are:

  • Fatal
  • Life-threatening
  • Disabling or incapacitating
  • Result in or prolong hospitalisation
  • Congenital abnormalities
  • Medically significant

Return to the Yellow Card Scheme main page