As of January 1, 2019, a health professional who is aware of an adverse event following immunization must report the event to the medical health officer as per the Reporting Information Affecting Public Health Regulation, Part 2, Division 1, Section 5 of the Public Health Act.
Events that must be reported include:
- serious events (life-threatening or resulting in death, requiring hospitalization, resulting in a residual disability, associated with congenital malformation)
- events requiring urgent medical attention
- unusual or unexpected events (for example, an event that has not been identified previously or has been identified before but is occurring with greater frequency in the population)
- clusters of events: known or new events that occur in a geographic or temporal cluster (for example, 6 in a week or 6 in a single Health Service Delivery Area)
Events that should not be reported:
- local injection site reactions and non-specific systemic reactions (for example, headache, myalgia) that are known to occur with the vaccine(s), unless these are more frequent or severe than expected based on clinical trial findings (However, always counsel clients about expected reactions following immunization and how to manage these reactions.)
- events that have another obvious cause (for example, co-existing conditions)
