Adverse event following COVID-19 vaccination

Vaccinations for COVID-19 commenced 21 February 2021. Adverse Events of Special Interest (AESI), as well as serious, unexpected or uncommon AEFI, need to be reported for the COVID-19 Vaccination Program as they are notifiable conditions under the Public Health Regulation 2018 (Schedule 1).

In Queensland, health practitioners are required to report COVID-19 AEFI to Queensland Health which will report them to the Therapeutic Goods Administration (TGA) Medicines Regulation Division as well.

Depending on the type of health provider, there are multiple ways for Adverse Events Following Immunisation (AEFI) for COVID-19 Vaccinations to be reported to Queensland Health.

Queensland Health employees

Queensland Health-controlled COVID-19 vaccination service providers (this includes all Queensland Health employees and contractors providing vaccination services) should use:

• the Queensland COVID Vaccination Management Solution (QCVMS) to report AEFI which occur at the time of vaccination; or
• the COVID-19 AEFI Portal to report other AEFIs
• some sites may also be able to use the ieMR to report COVID-19 AEFI
• In downtime situations the COVID 19 Adverse Event Following Immunisation Reporting Form (PDF 2410 kB) can be completed and emailed to COVID_AEFI@health.qld.gov.au.

The portal allows providers to directly enter information relevant to an adverse event/s experienced following a COVID-19 vaccination. Registration is required to access the portal. To register, visit the COVID-19 AEFI Portal. Following registration, you will be able to:

• submit a COVID-19 AEFI
• review summary information of COVID-19 AEFI you have previously submitted
• submit further AEFIs without requiring re-registration.

Non-Queensland Health employees including general practitioners, pharmacists and private providers should refer to the Information for primary care page for instructions on reporting AEFIs.

View Printable version of the COVID 19 Adverse Event Following Immunisation Reporting Form (PDF 2410 kB).

Case Reporting Forms

Case Reporting Forms (CRFs) have been developed to assist Queensland Health and the TGA:

• Queensland Health Vaccine Control Centre Post COVID-19 vaccination Suspected Anaphylaxis follow-up form (PDF 763 kB)
  This form has been developed to capture details on anaphylaxis following COVID-19 vaccine administration that are aligned to the Brighton Collaboration’s Anaphylaxis case definition. It should be used in addition to normal AEFI reporting requirements.
• Queensland Health Vaccine Command Centre Thrombosis – thrombocytopenia Form (PDF 749 kB)
  This form has been developed to capture details on suspected Vaccine Induced Thrombosis with Thrombocytopenia (VITT) also known as Thrombosis with Thrombocytopenia Syndrome (TTS) following COVID-19 vaccine administration. It should be used in addition to normal AEFI reporting requirements.
• Queensland Health Myocarditis & Pericarditis Clinical Reporting Form (PDF 746 kB)
  This form has been developed to capture details on pericarditis and/or myocarditis following COVID-19 vaccine administration. It should be used in addition to normal AEFI reporting requirements.
• Therapeutic Goods Administration Adverse Events of Special Interest (PDF 166 kB)
  To help confirm the safety profile of COVID-19 vaccines, particularly with respect to possible side effects that rarely occur, the TGA closely monitors for specific adverse events known as ‘adverse events of special interest’ (AESI). A list of these adverse events of special interest can be found in the above.

Please refer to deaths reportable to the coroner page for information on if a person dies as a direct result of having received the COVID-19 vaccine

Vaccine Administration Errors

A Vaccine Administration Error (VAE) is any preventable event that may cause or lead to inappropriate use of vaccine or patient harm. Incidents of vaccine administration errors are notifiable as adverse events following immunisation (AEFI) if there is harm to the patient or the patient experiences an adverse event. All AEFI should be reported as per above, however for VAE, please also complete this Queensland Health Vaccine Administration Error (VAE) reporting form (DOCX 480 kB) and return to COVID_AEFI@health.qld.gov.au.  It is imperative that any significant or potentially significant VAE, especially those that have the potential to impact multiple consumers are reported to the VCC directly via phone as early as practical.