Australia’s active vaccine safety system

 

COVID-19 vaccine safety surveillance

The national roll-out of COVID-19 vaccines commenced on 22 February 2021, and AusVaxSafety is conducting active vaccine safety surveillance of the vaccines in use. The vaccines currently being supplied are Comirnaty BNT162b2 (mRNA), sponsored by Pfizer Australia Pty Ltd, and COVID-19 Vaccine AstraZeneca, sponsored by AstraZeneca.

Surveillance data have been provided by Vaxtracker and SmartVax based on surveys sent on Day 3 after the vaccination, and data presented here are from surveys received up to 11 April 2021. These data are updated weekly. 
 

AVS COVID vaccine safety map

 

AusVaxSafety active vaccine safety surveillance system complements the Therapeutic Goods Administration (TGA) enhanced safety surveillance activities. View the TGA COVID-19 vaccine weekly safety report here. 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

    Current as at 11 April 2021

    84,439 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    63.3%
    reported no adverse event

    63.3%
    reported no adverse event


     

    36.7%
    reported any adverse
    event, including...


     

    4.7%
    who reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

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

     

     

    31,001 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

    Current as at 11 April 2021

    44,888 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    39.9%
    reported no adverse event

    39.9%
    reported no adverse event


     

    60.1%
    reported any adverse
    event, including...


     

    21.9%
    who reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

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

     

     

    26,997 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

    Current as at 11 April 2021

    74,656 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    36.2%
    reported no adverse event

    36.2%
    reported no adverse event


     

    63.8%
    reported any adverse
    event, including...


     

    23.2%
    who reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    1.6%
    who reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    47,660 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.