Pharmacovigilance module 1 - Serious Adverse Events

What is an adverse event? A serious adverse event?

What is an adverse event? A serious adverse event?Untitled content

What is an adverse event?

  • Any untoward medical occurrence experienced by a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment,
    • including any sign, symptom or lab abnormality.
      • e.g. high liver enzymes following paracetamol intake.
    • including aggravation or change to a pre-existing condition.
      • e.g. worsening of pre-existing paraesthesia following fluconazole treatment.

Is this situation describing an AE or there is not AE in this situation? - Patient EE is unwell since a few days; he reports profuse sweating. He is receiving anti-retroviral therapy (darunavir/ritonavir + tenofovir) for several years.

  • At least one AE
  • No AE