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 13 June 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 13 June 2021

    326,706 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


     

    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.

     

     

    122,566 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 13 June 2021

    4,083 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    63.1%
    reported no adverse event

    63.1%
    reported no adverse event


     

    36.9%
    reported any
    adverse event


     

    7.4%
    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.

     

     

    1,506 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 13 June 2021

    176,438 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    41.1%
    reported no adverse event

    41.1%
    reported no adverse event


     

    58.9%
    reported any
    adverse event


     

    22.9%
    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.

     

     

    103,959 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 13 June 2021

    2,257 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    43.4%
    reported no adverse event

    43.4%
    reported no adverse event


     

    56.6%
    reported any
    adverse event


     

    24.0%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    3.8%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    1,278 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 13 June 2021

    325,261 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


     

    17.7%
    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.

     

     

    183,543 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 13 June 2021

    3,197 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    45.7%
    reported no adverse event

    45.7%
    reported no adverse event


     

    54.3%
    reported any
    adverse event


     

    17.7%
    reported missing work, study
    or routine duties
    for a short period (<1 day
    missed by the majority).
     

     

    1.9%
    reported seeing a doctor
    or going to emergency
    department in the days after
    vaccination.

     

     

    1,736 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 13 June 2021

    14,132 people responded to an SMS/email about their health in the three days after their COVID-19 vaccinations.

    65.6%
    reported no adverse event

    65.6%
    reported no adverse event


     

    34.4%
    reported any
    adverse event


     

    8.7%
    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.

     

     

    4,866 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.