SAEFVIC is the central reporting service in Victoria for any significant adverse event following immunisation (AEFI). Reporting adverse events is not mandatory in Victoria, however doing so allows the rapid investigation of any potential vaccine or system problems by Victorian and national health authorities (Therapeutic Goods Administration). This helps to ensure a safe and effective immunisation program and it maintains community confidence in vaccines.

Following the report of adverse events, SAEFVIC can facilitate individualised clinical assistance for patients and families affected by an AEFI. This may be done via a face-to-face or telehealth consultation with a specialist or with an immunisation nurse over the phone.

  • What is an AEFI?

    An AEFI is any unexpected or severe side effect that can happen following the administration of any immunisation. Such an event may be caused by the immunisation itself or may be unrelated and occur by chance after the immunisation. Severe side effects from vaccines are rare and common side effects are usually mild and short-lasting.

    An AEFI can also be an error related to the way a vaccine was stored, prepared or administered.

  • What happens with reports?

    SAEFVIC forwards all adverse event reports to the TGA who use this information to assist in the identification of any possible vaccine safety signal or ‘flag’ for concern. If a safety signal is identified, it is thoroughly investigated to determine the possible role that the vaccine or system played in causing the event.

  • What symptoms should be reported?

    You should report:

    • Any event felt to be significant following immunisation, regardless of whether you think the symptoms were related to the vaccine or not
    • Any expected symptoms that have not gone away after a few days
    • Any side effects following an immunisation which requires assessment by a doctor or nurse
    • Suspected shoulder injury related to vaccine administration (SIRVA)
    • Any immunisation administration errors
  • What symptoms do not need reporting?

    You do not need to routinely report:

    • Minor, common or expected side effects
      • These may include pain, redness, swelling and tenderness at the injection site, tiredness, headache, muscle pain, nausea, fever and chills, feeling unwell or joint pain
      • For further details of minor, common or expected side effects to National Immunisation Program (NIP) and influenza vaccines refer to Vaccine Side Effects
      • For further details of minor, common and expected side effects following COVID-19 vaccines refer to After your AstraZeneca Vaccine and After your Pfizer (COMIRNATY) Vaccine
  • Reporting an adverse event following a COVID-19 vaccine

    • There are two pathways for reporting AEFI following the administration of COVID-19 vaccines:
      • Any significant adverse events (as outlined in the criteria above) should be reported via the ‘SAEFVIC extended report’ button below. The vaccinee (person who received the vaccine) may receive follow up clinical advice (email or telephone) for these reports.
      • If you would like to contribute to data collection to assist health authorities in understanding the frequency of these symptoms occurring, you may report common or expected side effects via the ‘SAEFVIC rapid report’ button below. Please note that there will be no clinical follow up provided for these reports.
  • Reporting an adverse event following a non-COVID-19 vaccine

    Adverse events following the administration of vaccines on the National Immunisation Program, influenza vaccines and travel vaccines can be reported here:

Please note: SAEFVIC is a reporting service and not an emergency contact. Hours of operation are Monday – Friday, 9am – 5pm.

Anyone who experiences a severe AEFI should first seek medical attention from a health professional. For advice on symptoms following COVID-19 vaccines, we encourage callers to contact the Coronavirus Hotline on 1800 675 398.

Please see your GP, local emergency department or call 000 if immediate assistance is required.

Please see the below video for a demonstration on how to complete an extended SAEFVIC report.

Authors: Nigel Crawford (Director, SAEFVIC, Murdoch Children’s Research Institute), Georgina Lewis (Clinical Manager, SAEFVIC, Murdoch Children’s Research Institute) and Rachael McGuire (Research Nurse, SAEFVIC, Murdoch Children’s Research Institute)

Reviewed by: Georgina Lewis (Clinical Manager, SAEFVIC, Murdoch Children’s Research Institute) Rachael McGuire (MVEC Education Nurse Coordinator), Francesca Machingaifa (MVEC Education Nurse Coordinator) and Daryl Cheng (MVEC Medical Lead)

Date: July 2021

Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.