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, 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 25 July 2021. These data are updated 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 25 July 2021

    756,844 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    62.9%
    reported no adverse event

    62.9%
    reported no adverse event


     

    37.1%
    reported any
    adverse event


     

    6.4%
    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.

     

     

    281,083 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 25 July 2021

    9,954 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    62.5%
    reported no adverse event

    62.5%
    reported no adverse event


     

    37.5%
    reported any
    adverse event


     

    7.9%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    0.9%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    3,731 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 25 July 2021

    531,147 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    43.5%
    reported no adverse event

    43.5%
    reported no adverse event


     

    56.5%
    reported any
    adverse event


     

    21.0%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    1.4%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    300,334 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 25 July 2021

    5,761 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    45.2%
    reported no adverse event

    45.2%
    reported no adverse event


     

    54.8%
    reported any
    adverse event


     

    22.4%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    2.5%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    3,156 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 25 July 2021

    399,883 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    44.6%
    reported no adverse event

    44.6%
    reported no adverse event


     

    55.4%
    reported any
    adverse event


     

    17.0%
    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.

     

     

    221,448 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 25 July 2021

    3,970 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    46.9%
    reported no adverse event

    46.9%
    reported no adverse event


     

    53.1%
    reported any
    adverse event


     

    17.4%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    1.7%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    2,107 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 25 July 2021

    132,339 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    72.1%
    reported no adverse event

    72.1%
    reported no adverse event


     

    27.9%
    reported any
    adverse event


     

    6.0%
    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.

     

     

    36,890 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 25 July 2021

    1,682 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    73.8%
    reported no adverse event

    73.8%
    reported no adverse event


     

    26.2%
    reported any
    adverse event


     

    7.6%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    0.8%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    441 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.