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Vaccine safety

Immunisation lowers the chance of getting and spreading disease.

Severe side effects from vaccines are uncommon, and typical side effects are usually mild and short-lived. The risk of experiencing health problems from not being immunised is higher than the risks of getting vaccinated. In Australia, the AusVaxSafety safety system monitors side effects after vaccination.

Vaccine side effects

Vaccines, like other medicines, can cause side effects. Minor side effects like pain, redness or swelling at the injection site, mild fever or aches can occur. These typically last for a short time and resolve on their own. Some of these symptoms can indicate that your body is developing immunity against the targeted disease.

Serious side effects from vaccines are exceedingly rare. If you notice severe or long-lasting side effects, it's important to seek medical advice.

You can get help at:

Vaccine safety monitoring

Before a vaccine can be used in Australia, it undergoes rigorous assessment by the Therapeutic Goods Administration (TGA), meeting strict standards. This includes:

  • reviewing clinical trial data
  • examining ingredients, chemistry and the manufacturing process
  • ensuring the quality of each vaccine batch before distribution.

Every vaccine within Australia must pass 3 trial phases before the TGA registers the vaccine for use.

Phase 1
Small groups of healthy adults receive the vaccine to check safety.

Phase 2
Hundreds of people receive the vaccine to assess immune response, dosage needed for protection and side effects.

Phase 3
Thousands of people get the vaccine to test its effectiveness in large populations and identify any uncommon or serious side effects.

Following registration, the TGA also monitors vaccine safety through passive surveillance, where consumers, healthcare professionals, vaccine suppliers and health departments can report side effects to the TGA.

Each state and territory also monitor vaccine safety. The Western Australian Vaccine Safety Surveillance (WAVSS) system is the reporting service in WA for any significant adverse event following immunisation (AEFI). In WA, health professionals have a legal requirement to notify adverse events to the Western Australian Vaccine Safety Surveillance system (WAVSS).

You can also report an event if you or someone you care for has experienced an adverse effect following immunisation (AEFI) and needed medical assessment or treatment.  

WA also conducts active vaccine safety surveillance where some vaccine recipients are contacted within the week after vaccination via SMS or email with a brief survey to collect data on any symptoms they may have experienced following the immunisation. WA active surveillance contributes to the national AusVaxSafety reporting.

Vaccine safety ingredients

Vaccine ingredients vary based on their purpose and may include one of the following:

  • a tiny amount of weakened live virus
  • inactivated viruses or bacteria
  • fragments of bacteria
  • modified bacterial toxins
  • small amounts of preservatives or antibiotics for stability.

Each ingredient serves a specific role and undergoes rigorous safety testing during manufacturing.

The TGA thoroughly evaluates the safety, quality and effectiveness of each vaccine ingredient before approving its use in Australia.

For more details about vaccine ingredients, you can refer to the TGA’s product information.

More information

Where to get help?