Australia’s active vaccine safety system

 

COVID-19 vaccine safety surveillance

AusVaxSafety is conducting active vaccine safety surveillance of the COVID-19 vaccines in use in Australia to ensure their ongoing safety. The vaccines currently being used are Comirnaty BNT162b2 (mRNA), sponsored by Pfizer Australia Pty Ltd, and COVID-19 Vaccine AstraZeneca, sponsored by AstraZeneca.

Surveillance data are provided by Vaxtracker, SmartVax and the Victorian Department of Health COVID-19 Vaccine Management System based on surveys sent on Day 3 after the vaccination, and data presented here are from surveys received up to 12 September 2021.

With the recent expansion of the COVID-19 vaccine rollout to individuals aged 12-15 and the imminent introduction of the Moderna COVID-19 vaccine to the vaccination program, AusVaxSafety will return to updating the data on this page weekly.

AVS COVID vaccine safety map 5 May 2021

 

* Surveys sent on Day 3 post vaccination. NOTE: Adverse events are self-reported, have not been clinically verified, and do not necessarily have a causal relationship with the vaccine.

AusVaxSafety had identified an increase in the rate of medical attendance (mostly to general practice/clinics) reported by vaccine recipients in the 3 days following dose 1 of Comirnaty and dose 1 of COVID-19 Vaccine AstraZeneca for those aged <55 years in the week of 11 April to 17 April. However, the rate since 18 April has returned to expected rates. 

There have been no reports of thrombosis thrombocytopenia syndrome  (TTS) following COVID-19 vaccination reported to AusVaxSafety. For more information on all vaccine safety monitoring in Australia and on TTS, see weekly TGA safety updates

AusVaxSafety active vaccine safety surveillance system complements the TGA's enhanced safety surveillance activities. Find out more about how the TGA monitors the safety of COVID-19 vaccines and how you can report side effects on the TGA website.

Read more about how AusVaxSafety is conducting national COVID-19 vaccine safety surveillance in Australia here.

  • Comirnaty vaccine Dose 1 - All participants

    Current as at 12 September 2021

    1,537,902 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    63.2%
    reported no adverse event

    63.2%
    reported no adverse event


     

    36.8%
    reported any
    adverse event


     

    7.5%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    0.6%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    565,274 people reported one or more adverse events.


    The most commonly reported were (% of total participants):



     

    These symptoms are known to occur after vaccination. They are generally mild and short-lived. As with any adverse event reports, not all symptoms reported may be caused by the vaccine; they may be coincidental and due to other causes. Refer to Comirnaty Product Information on the TGA website for further details.

  • Comirnaty vaccine Dose 1 - Aboriginal and Torres Strait Islander participants

    Current as at 12 September 2021

    22,584 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    62.2%
    reported no adverse event

    62.2%
    reported no adverse event


     

    37.8%
    reported any
    adverse event


     

    9.4%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    1.0%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    8,535 people reported one or more adverse events.


    The most commonly reported were (% of total participants):



     

    These symptoms are known to occur after vaccination. They are generally mild and short-lived. As with any adverse event reports, not all symptoms reported may be caused by the vaccine; they may be coincidental and due to other causes. Refer to Comirnaty Product Information on the TGA website for further details.

  • Comirnaty vaccine Dose 2 - All participants

    Current as at 12 September 2021

    1,038,345 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    44.0%
    reported no adverse event

    44.0%
    reported no adverse event


     

    56.0%
    reported any
    adverse event


     

    21.1%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    1.2%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    581,514 people reported one or more adverse events.


    The most commonly reported were (% of total participants):



     

    These symptoms are known to occur after vaccination. They are generally mild and short-lived. As with any adverse event reports, not all symptoms reported may be caused by the vaccine; they may be coincidental and due to other causes. Refer to Comirnaty Product Information on the TGA website for further details.

  • Comirnaty vaccine Dose 2 - Aboriginal and Torres Strait Islander participants

    Current as at 12 September 2021

    13,293 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    46.1%
    reported no adverse event

    46.1%
    reported no adverse event


     

    53.9%
    reported any
    adverse event


     

    22.3%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    2.3%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    7,170 people reported one or more adverse events.


    The most commonly reported were (% of total participants):



     

    These symptoms are known to occur after vaccination. They are generally mild and short-lived. As with any adverse event reports, not all symptoms reported may be caused by the vaccine; they may be coincidental and due to other causes. Refer to Comirnaty Product Information on the TGA website for further details.

  • COVID-19 Vaccine AstraZeneca Dose 1 - All participants

    Current as at 12 September 2021

    497,797 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    43.6%
    reported no adverse event

    43.6%
    reported no adverse event


     

    56.4%
    reported any
    adverse event


     

    19.0%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    1.1%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    280,543 people reported one or more adverse events.


    The most commonly reported were (% of total participants):



     

    These symptoms are known to occur after vaccination. They are generally mild and short-lived. As with any adverse event reports, not all symptoms reported may be caused by the vaccine; they may be coincidental and due to other causes. Refer to COVID-19 Vaccine AstraZeneca Product Information on the TGA website for further details.

  • COVID-19 Vaccine AstraZeneca Dose 1 - Aboriginal and Torres Strait Islander participants

    Current as at 12 September 2021

    5,148 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    47.0%
    reported no adverse event

    47.0%
    reported no adverse event


     

    53.0%
    reported any
    adverse event


     

    18.3%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    1.8%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    2,728 people reported one or more adverse events.


    The most commonly reported were (% of total participants):



     

    These symptoms are known to occur after vaccination. They are generally mild and short-lived. As with any adverse event reports, not all symptoms reported may be caused by the vaccine; they may be coincidental and due to other causes. Refer to COVID-19 Vaccine AstraZeneca Product Information on the TGA website for further details.

  • COVID-19 Vaccine AstraZeneca Dose 2 - All participants

    Current as at 12 September 2021

    357,238 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    75.0%
    reported no adverse event

    75.0%
    reported no adverse event


     

    25.0%
    reported any
    adverse event


     

    4.8%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    0.4%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    89,359 people reported one or more adverse events.


    The most commonly reported were (% of total participants):



     

    These symptoms are known to occur after vaccination. They are generally mild and short-lived. As with any adverse event reports, not all symptoms reported may be caused by the vaccine; they may be coincidental and due to other causes. Refer to COVID-19 Vaccine AstraZeneca Product Information on the TGA website for further details.

  • COVID-19 Vaccine AstraZeneca Dose 2 - Aboriginal and Torres Strait Islander participants

    Current as at 12 September 2021

    3,478 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    75.5%
    reported no adverse event

    75.5%
    reported no adverse event


     

    24.5%
    reported any
    adverse event


     

    6.6%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    0.7%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    853 people reported one or more adverse events.


    The most commonly reported were (% of total participants):



     

    These symptoms are known to occur after vaccination. They are generally mild and short-lived. As with any adverse event reports, not all symptoms reported may be caused by the vaccine; they may be coincidental and due to other causes. Refer to COVID-19 Vaccine AstraZeneca Product Information on the TGA website for further details.

The profile of reported events from AusVaxSafety surveillance for both Comirnaty and COVID-19 Vaccine AstraZeneca is similar to that reported in clinical trials and from post-marketing surveillance overseas. These expected adverse events are related to the immune response to vaccination and are expected to resolve within 1-3 days after vaccination.

Links to further information on the expected profile for Coimrnaty and COVID-19 AstraZeneca vaccine are available below: 

AusVaxSafety will continue to closely monitor the safety data of all COVID-19 vaccines in use in Australia in conjunction with the TGA.