The MHRA is particularly keen to receive reports of reactions that are regarded as serious. Serious reactions are defined as:

  • Fatal
  • Life threatening
  • Disabling or incapacitating
  • Resulting in, or prolonging, hospitalisation
  • Congenital abnormalities
  • Those which are deemed by the reporter as medically significant

Further information on, and examples of, serious reactions can be found here.