Vaccine safety monitoring

The TGA is responsible for ensuring all publicly available vaccines are safe and work as intended. Once the TGA has approved a flu vaccine, it continues to be monitored in several ways:

• National surveillance;
• Further clinical trials;
• Continuous monitoring for side effects.

The AusVaxSafety organisation monitors vaccine safety in Australia, headed by the National Centre for Immunisation and funded by the Department of Health.

AusVaxSafety is responsible for tracking the safety of vaccines from the time they are administered to identify any adverse reactions or side effects. The organisation provides an annual report summarising data provided by patients, carers and parents regarding any reactions to vaccinations. Vaccine recipients, carers and parents report any adverse reactions by responding to an SMS after receiving a vaccine through the National Immunisation Program.

Undesirable effects and reactions can also be reported directly to the TGA via the internet using any of the following:

• Report a Medicinal Side Effect form;
• AEFI, or Adverse Event Following Immunisation form.

The TGA regularly reviews all vaccine reports and may refer to expert committees, including the Advisory Committee on Vaccines (ACV) if necessary.

Flu vaccination side effects may also be reported via phone on 1300 134 237. A representative will then guide how you can submit a report and manage the side effects mentioned above. You may also approach your territory or state health service to report adverse reactions to vaccinations.