This report includes data up to and including 4 December 2022. We update this page every Friday. 

Data are subject to change as reports continue to be received.

An adverse event following immunisation is any untoward medical occurrence that happens following administration of a vaccine. It can be coincidentally associated with immunisation, without necessarily being caused by the vaccine.

Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC) is Victoria’s immunisation safety service. SAEFVIC encourages reporting of all unexpected, medically attended, or serious adverse events and provides clinical follow up to vaccinees that have an adverse event.

At a glance

  • Details

    • An adverse event following immunisation is any untoward medical occurrence that happens following administration of a vaccine. It can be coincidentally associated with immunisation, without being caused by the vaccine, or may occur as a result of the vaccination.
    • SAEFVIC is Victoria’s immunisation safety service. Working closely with the Department of Health and a specialist immunisation nursing review system, SAEFVIC responds to potential immunisation safety issues, such as adverse events, and inform Victorians about risks we’ve documented. Medical, nursing and epidemiology experts review adverse event data regularly to ensure there are no safety signals that require action.
    • We also work with the national Therapeutic Goods Administration (TGA), which covers adverse events reported across Australia in a fortnightly update.
    • Most reported adverse events (82%) are not serious (for example, a sore arm, a slight fever, or fatigue). When reports are considered by the number of vaccines administered, 0.05% of people vaccinated have reported a serious adverse event. Adverse event reports by anyone – health care workers and community members, help make our immunisation program safer.
    • Victoria closely monitors all safety signals and is currently reporting on six safety signals temporally associated (related in time) with COVID-19 vaccines:
      Myocarditis/pericarditis (inflammation in or around the heart)
      Thrombosis with thrombocytopenia (blood clots with low platelets in the blood)
      Immune thrombocytopenia (low platelets in the blood)
      Guillain-Barré Syndrome (weakness due to inflamed nerves)
      – acute kidney injury
      – capillary leak syndrome (a severe form of swelling in multiple parts of the body).
    • The benefits of vaccines authorised in Australia continue to outweigh the risks. National guidance should be followed, and individual queries discussed with your GP and/or your treating specialist.

Adverse Events Following Immunisation

The information in this report reflects detailed information from SAEFVIC. These data may change as more reports continue to be received and more information about cases becomes available.

All adverse event reports received by SAEFVIC are included in this report, regardless of whether vaccines caused them, or they occurred coincidentally.

  • By week

    A total of 45,175 reports (2.7 per 1,000 doses administered) have been received, of which 8,135 were considered serious (0.5 per 1,000 doses administered).

    Figure 1: Weekly number of COVID-19 vaccine adverse event reports and rate per 1,000 doses administered

    Data note: The most recent week is subject to a time lag where there may be delays in receiving and processing reports.

  • By vaccine name and dose number

    This figure shows adverse events per 1,000 doses by vaccine name and dose number. This shows both common or expected (such as a sore arm or headache) and serious adverse events (such as an anaphylactic reaction).

    COVID-19 vaccines approved and currently in use in Australia are Vaxzevria (AstraZeneca), Comirnaty (Pfizer), Spikevax and Spikevax Bivalent (Original/BA.1) (Moderna) and Nuvaxovid (Novavax).

    The recommendation by ATAGI for specific population groups to receive a fourth dose (winter booster) from 25 March 2022 was expanded to a broader population of individuals aged 30 years and over on 7 July 2022. To date, SAEFVIC has received 545 reports of AEFIs following a fourth (winter booster) dose, with 140 reports defined as serious AEFI. As the roll-out of winter booster doses continues, rates will be better informed.

    Figure 2: Adverse event reports per 1,000 doses, by vaccine name and dose
  • By most frequently reported adverse events

    Among the 45,175 reports of one or more adverse event symptom, the most frequently reported symptoms are presented in Figure 3.

    A total of 114,905 individual symptoms have been reported. People can report more than one symptom.

    The most frequently reported adverse events are similar for Vaxzevria and mRNA vaccines (Comirnaty, Spikevax and Spikevax Bivalent (Original/BA.1)), with the exception of chest pain and myocarditis/pericarditis, which are more common following mRNA vaccines.

    Figure 3: Most frequently reported individual symptoms, per 1,000 doses
    Vaxzevria
    mRNA vaccines (Comirnaty, Spikevax & Spikevax Bivalent (Original/BA.1))
    A person may report more than 1 symptom
  • Serious adverse events

    All reports of serious adverse events undergo SAEFVIC review to see if there are any safety issues requiring further action. These processes include meeting regularly with experts to review the information to ensure there are no safety signals that require action. Any new or unexpected safety concerns are detected quickly and acted upon immediately.

    The majority of reported adverse events are non-serious. Serious adverse events were reported in 0.05% of vaccine doses administered. SAEFVIC encourages reporting of unexpected, medically attended, or serious adverse events; however, the majority of reports received (82%) did not meet the definition of a serious adverse event.

    Figure 4: Serious adverse event reports per 1,000 doses, by vaccine name and dose

Adverse Events of Special Interest

The international Brighton Collaboration have identified specific conditions or syndromes as Adverse Events of Special Interest (AESI) for COVID-19 vaccines and for which SAEFVIC conducts enhanced monitoring. Reports of AESI are reviewed using the Brighton Collaboration criteria. The rate of reported AESI is then compared with the expected background rates from the Victorian community that would occur coincidentally in the population regardless of vaccination.

Individual cases or clusters are reviewed by experts. If a safety issue is found to be related to immunisation, the Department of Health will take appropriate action, including communicating new risks to Victorians and healthcare providers. If there is confirmation that an adverse event of special interest is causally related to a vaccine, the TGA may recommend updating the product information or changing the recommended use of the vaccine.

Victoria closely monitors all safety signals and is currently reporting on six safety signals temporally associated with COVID-19 vaccines:

  • Myocarditis-pericarditis

    Myocarditis and pericarditis are inflammation of the heart muscle or pericardium (the outer lining of the heart), with symptoms including chest pain, irregular heartbeat and shortness of breath. Both are common with COVID-19 infection and damage to the heart is frequently severe after infection. Myocarditis has been associated with all of the COVID-19 vaccines used in Australia. The risk of myocarditis following immunisation is highest in young persons following dose 2 of an mRNA vaccine (Spikevax/Moderna or Comirnaty/Pfizer). The Australian Technical Advisory Group on Immunisation (ATAGI) have emphasised that the protective benefits of the vaccine greatly outweigh the risk of these rare adverse events. The TGA has determined one myocarditis related death as likely to be associated with vaccination.

    Figure 5: Rate of myocarditis and pericarditis per 100,000 mRNA doses administered, by dose number
    Figure 6: Rate of myocarditis and pericarditis per 100,000 mRNA doses administered, by age group
    Myocarditis
    Pericarditis

    Cases of pericarditis are as reported to SAEFVIC. Not all causes have been clinically investigated and confirmed as pericarditis.

    Adverse event reporting to SAEFVIC indicates the reporting rate of myocarditis following Spikevax is 2.9-times higher than following Comirnaty (Figure 7). This finding has been reported to the National Regulator, Therapeutic Goods Administration (TGA).

    Figure 7: Overall reporting rate of myocarditis per 100,000 mRNA doses (1 and 2) administered, by mRNA vaccine brand

    The grey lines in the chart above show the plausible range of the true myocarditis rate in the population following Comirnaty or Spikevax vaccination with a 95% confidence level. When comparing the two vaccine brands, the absence of these ranges overlapping provide statistical strength to the significance of the findings.

  • Thrombosis with Thrombocytopenia Syndrome

    Thrombosis with Thrombocytopenia Syndrome (TTS) is a rare syndrome involving blood clots in association with low platelets that have been reported in people who have received the COVID-19 Vaxzevria vaccine. The European Medicines Agency first identified potential cases on 11 March 2021 and the first Victorian case was identified on 1 April 2021. To date, there has been one death associated with TTS in Victoria

    TTS is classified into two tiers, according to the location of the clot site and clinical severity:

    • Tier 1: defined as clots in an unusual location, such as the brain or abdomen, and a low platelet count with or without a positive test for antibodies that activate platelets (anti-PF4 antibodies);
    • Tier 2: defined as only clots found in more usual locations such as the legs or lungs with a low platelet count and a positive test for anti-PF4 antibodies.

    Rates of TTS are higher in younger age groups and this population also experience greater severity of disease. Tier 1 TTS is more common in younger people and in females.

    Figure 8: Rate of TTS cases per 100,000 Vaxzevria doses administered (dose 1), by age group and tier

    Rates for TTS are calculated using the number of doses administered as at 14 days ago. This is in line with national reporting and accounts for the delayed onset period of TTS cases.

  • Immune Thrombocytopenia

    Immune thrombocytopenia following vaccination with Vaxzevria has been raised as an international signal of concern. Immune thrombocytopenia is a bleeding disorder characterised by abnormally low levels of platelets (part of the blood that helps clots form). Low platelets are also a feature of thrombosis with thrombocytopenia (TTS) following Vaxzevria vaccination, therefore cases are carefully investigated and are only declared as immune thrombocytopenia in the absence of a thromboembolic event.

    • SAEFVIC has received 150 reports of abnormally low levels of platelets.
    • Rates of immune thrombocytopenia following Vaxzevria increase with age (Figure 9).
    • Clinical investigation of cases reported between February and October 2021 have been published in the Journal Vaccine.
    Figure 9: Rate of immune thrombocytopenia cases by age group, per 100,000 Vaxzevria administered
  • Guillain-Barré Syndrome

    Guillain-Barré Syndrome (GBS) is an autoimmune disorder occurring when the patient’s own immune system damages peripheral nerves and nerve roots, causing progressive muscle weakness and paralysis. It is a known rare condition that can occur following events that trigger the immune system such as viral infection or vaccination.

    • SAEFVIC has received 61 reports with symptoms suggestive of GBS.
    • Rate of confirmed GBS cases is consistent with the age distribution of persons receiving Vaxzevria (Figure 10).
    • Clinical investigation of cases reported between February and November 2021 have been published in the Journal Vaccine.
    Figure 10: Rates of GBS confirmed cases by age group, per 100,000 Vaxzevria administered
  • Acute Kidney Injury

    Although very rare, acute kidney injury (AKI) has been reported in people following a COVID-19 vaccination. Vomiting and diarrhoea can be common reported COVID-19 vaccine adverse events, which can lead to dehydration and exacerbate underlying kidney conditions. It’s important that people vulnerable to kidney conditions stay well hydrated after their COVID-19 vaccination. Clinical guidelines are available in appendix 22 of the Victorian COVID-19 Vaccination Guidelines.

  • Death

    Mortality reported following administration of a vaccine may be coincidentally associated in time, without necessarily being caused by the vaccine.

    Deaths are referred to the coroner usually when the cause is not clear. Deaths post vaccination referred to the coroner should not be interpreted as causally related with vaccine. It is standard practice to report deaths to the Coroner for a variety of criteria. Preliminary information suggests that many of the reported deaths occurred in individuals with multiple health conditions which may be related to the cause of death.

    SAEFVIC has received 161 reports of death temporally associated with immunisation, noting this includes high COVID-19 vaccine coverage in Victoria’s residential aged care facilities. 55 reports were referred to (or reported by) the Victorian Coroner’s office to establish a cause of death. Of all cases reported to SAEFVIC:

    • 5 cases were assessed as likely to be associated with the vaccine by the TGA
      • These cases included 1 case of TTS, 1 case of GBS, 1 case of acute disseminated encephalomyelitis (ADEM), 1 case of a rare neurological condition related to transverse myelitis and 1 case of myocarditis (details of the case are outlined in the TGA public report)
    • 139 were assessed as having a likely alternate cause of death
    • For 16 cases, the contribution of the vaccine to the death was not determined (inadequate information available or indeterminate)
    • 1 case is still under investigation

    SAEFVIC has formalised clinical guidelines with the coroner in the context of the COVID vaccine program: ‘Management of deaths temporally associated with COVID-19 immunisation – Victorian Clinical Standard’. Deaths referred to the coroner may take several weeks to months before assessment is completed.

Victorian Specialist Immunisation Services

  • Details

    The Victorian Specialist Immunisation Services (VicSIS) network provides specialist vaccination services for Victorians who:

    • Have a higher risk of a serious adverse event following a COVID-19 vaccine (pre-vaccination)
    • Experience a significant adverse event following a COVID-19 vaccine (post-vaccination).

    VicSIS was established to support safe pathway to vaccination for Victorians most at risk of a serious adverse event. To date, VicSIS has conducted 12,608 pre-vaccination and post-vaccination consultations. Most people who have a VicSIS consultation are recommended routine or supervised vaccination.

    Figure 11: VicSIS consultation outcomes

Victoria's contribution to national reporting

  • Details

    The Therapeutic Goods Administration (TGA) collates adverse event reports submitted by each jurisdiction, and provides a national fortnightly update on vaccine safety. Victoria contributes to national reporting of all adverse event reports received.

    AusVaxSafety is an active vaccine safety surveillance system that supports monitoring of the safety of vaccines in Australia. AusVaxSafety sends a SMS message to a sample of people who have been vaccinated 3, 8 and 42 days after they’ve been vaccinated asking specifically if they have experienced an adverse event. De-identified responses are analysed nationally for vaccine safety signals.

    Figure 12: National AusVaxSafety SMS survey results

    Further information about AusVaxSafety survey results is available on their website. This includes analysis by vaccine brand, dose, vaccinee age, sex, and for Aboriginal and Torres Strait Islanders.

Definitions

  • Adverse Event Following Immunisation (AEFI)

    An adverse event is any untoward medical occurrence which follows immunisation. It isn’t necessarily causally related to the usage of the vaccine. The adverse event may be any:

    • unfavourable or unintended sign (eg. skin rash)
    • abnormal laboratory finding
    • symptom
    • disease.

    For more information, please refer to the Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO). Definition and Application of Terms for Vaccine Pharmacovigilance. Report of CIOMS/WHO Working group on Vaccine Pharmacovigilance. Geneva: CIOMS and WHO; 2012

  • Adverse event report

    One adverse event report, which represents one person, may report on more than one symptom (i.e. a serious or non-serious adverse event following immunisation, or adverse event).

  • Serious adverse event

    An adverse event is considered a serious AEFI if it:

    • results in death
    • is life-threatening (an event/reaction in which the patient was at real, rather than hypothetical, risk of death at the time of the event/reaction)
    • requires in-patient hospitalisation or prolongation of existing hospitalisation
    • results in persistent or significant disability/incapacity
    • results in a congenital anomaly/birth defect, or
    • is a medically important event or reaction
  • Adverse Event of Special Interest (AESI)

    This is a pre-specified medically significant event that has the potential to be causally associated with a vaccine product. It must be carefully monitored and confirmed by further special studies.

    For more information, please refer to World Health Organization. COVID-19 Vaccines: Safety Surveillance Manual.

  • Safety signal

    Information indicating a new and potentially causal association between a vaccine and an event that could affect health. The event is either unknown or incompletely documented. It could also indicate a new aspect of a known association. The primary purpose of vaccine post-market surveillance is to detect safety concerns. These concerns include a possible increase in the severity or frequency of expected adverse events, or one or more unexpected events (i.e., an event that is not consistent with Australian product information or labelling).

    For more information, please refer to World Health Organization: COVID-19 Vaccines

Data notes

  • Details

    The data presented in this report are estimates and may not accurately represent state COVID-19 vaccine adverse events for the following reasons:

    • there may be delays in receiving and/or processing reporting forms which may contribute to variations in the amount of reports presented weekly. There are also limitations to reporting practices such as underreporting, missing information, and differing adverse event reporting practices across healthcare providers in Victoria
    • information is collected on individuals for whom a report was submitted, not on the total number of individuals who experience an adverse event as not every adverse event is reported
    • new information contained in this report may not be comprehensive. It represents preliminary results of data received on a weekly basis. All data are subject to change
    • information on COVID-19 vaccine doses administered are obtained from the Australian Immunisation Register (AIR)
    • the data presented in this report represent reports received by SAEFVIC from vaccine providers, healthcare professionals, and vaccinees. Although data are carefully reviewed, it is possible that this report contains duplicate events
    • the current adverse event reporting results only reflect the population that is currently prioritised for vaccination. For more information on priority vaccination for COVID-19, please see the Commonwealth’s vaccination rollout phases.
    • adverse events of special interest are assessed according to the Brighton Collaboration criteria (if available).

Suggested citation

Surveillance of Adverse Events Following Vaccination in the Community (SAEFVIC) & Victorian Department of Health. Victorian COVID-19 vaccine safety report. Melbourne: Melbourne Vaccine Education Centre; 9 December 2022. [https://saefvic.online/vaccinesafety]

Acknowledgements: This report has been developed using Health Canada’s public facing adverse event report, reported side effects following COVID-19 vaccination in Canada, as a guide. Thank you to our colleagues at Health Canada for their collaboration.
We acknowledge all the vaccinees and healthcare professionals who have reported adverse events following immunisation as this plays an important role in supporting the COVID-19 vaccination program.
We also want to acknowledge all the SAEFVIC staff, VicSIS clinicians, and subject matter experts, who help support our vaccine safety activities here in Victoria.

Authors: Hazel Clothier (Lead Epidemiologist & Surveillance Manager, Epidemiology and Signal Detection, SAEFVIC), Nigel Crawford (Director, SAEFVIC), Jim Buttery (Head of Health Informatics, Epidemiology and Signal Detection, SAEFVIC)

Reviewed by: Hazel Clothier (Lead Epidemiologist & Surveillance Manager, Epidemiology and Signal Detection, SAEFVIC), Jesse Fryk (Epidemiologist, SAEFVIC), Jim Buttery (Head of Health Informatics, Epidemiology and Signal Detection, SAEFVIC)

Technical Support: MVEC

Date: December, 2022

Data are subject to change as reports continue to be received.

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.