Adverse event following immunisation (AEFI)
An AEFI is an untoward medical event which follows immunisation and does not necessarily have a causal relationship with the administration of the vaccine. The adverse event may be an unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.
Serious adverse event following immunisation
An AEFI is considered serious if it:
- is a medically important event or reaction
- requires hospitalisation or prolongs an existing hospitalisation
- causes persistent or significant disability or incapacity
- is life threatening
- causes a congenital anomaly/birth defect
- results in death.
It is possible for different people to have experienced the same event but for the report to be serious for one person and non-serious for another person.
Information on a new or known adverse event that may be caused by the vaccine and requires further investigation. Safety signals can be detected from a wide range of sources such as CARM reports, clinical studies and scientific literature.
See the data sheets and consumer medicine information for the expected reactions for approved COVID-19 vaccines.
COVID-19 Vaccine Safety Monitoring Process
Medsafe and CARM thank everyone who has contributed to the monitoring of COVID-19 vaccines. Please continue to report any adverse events following immunisation.