Adverse event following COVID-19 vaccination

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 and Vaccine Administration Errors (VAE)
• 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
• submit a Vaccine Administration Error Report
• review summary information of COVID-19 AEFI you have previously submitted
• submit further AEFIs without requiring re-registration.

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

General Practitioners (GPs) using specified practice software

General practitioners using the following practice software can complete an AEFI directly though their practice software and submit it to Queensland Health (via Medical Objects) and the TGA. Please click on the hyperlink to for instructions on how to install the relevant templates.

• Medical Director – Download the COVID 19 Adverse Event Following Immunisation Reporting template for Medical Director (RTF 43 kB)
• Best Practice - Download the COVID 19 Adverse Event Following Immunisation Reporting template for Best Practice (RTF 149 kB)
• Genie template for COVID-19 Adverse Event Following Immunisation reporting (4WT 21 kB)

If the program you are currently using isn’t in the above list, please use the below instructions in the interim.

Other health providers (other GPs, Commonwealth providers, private providers or pharmacists etc.)

All other COVID-19 vaccine providers in Queensland must report COVID-19 AEFIs using the COVID-19 AEFI PDF form. General practitioners, other healthcare workers and consumers can also report an AEFI using the PDF form.

To complete the COVID-19 AEFI form:

• Enter information into the PDF document online
• Once all of the information has been entered, click or tap the Email button. The Email button will automatically attach the PDF document to an email and populate the “To:” field with COVID_AEFI@health.qld.gov.au, making the email ready for sending.

Alternatively, the PDF can be printed or saved, completed, scanned and sent to COVID_AEFI@health.qld.gov.au.

Only one of the above approaches is required to submit an AEFI to Queensland Health. If one of these approaches are used, you do not need to complete a TGA AEFI form. Queensland Health will notify the TGA to enable national monitoring and reporting of AEFIs in Australia.

Vaccine details (batch number, serial number, dose, date of vaccine) can be found in the patient’s medical record, Australian Immunisation Register or on the vaccination card provided to the person when they received their vaccination.

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.

If you have concerns regarding administering a second dose of a vaccine because your patient has previously experienced significant side effects, we recommend you contact your local Public Health Unit for advice or consider referring your patient to the statewide Queensland Specialist Immunisation Service (QASIS) located at the Royal Brisbane and Women’s Hospital.

Please refer to the below 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 478 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.

Deaths reportable to the coroner

If a person dies as a direct result of having received the COVID-19 vaccine, for example, anaphylaxis, or an AEFI is considered to have significantly contributed to or hastened the person’s death, the death is reportable under the Coroners Act 2003 as a health care related death. The death is to be reported to the Coroners Court of Queensland by Form 1A Medical practitioner report of a death to a coroner in the first instance. If the person dies in hospital, the body is to remain in the hospital morgue pending further advice from the Coroners Court. If the person dies in the community, the body may be transferred to the family’s nominated funeral director pending further advice from the Coroners Court.

Queensland Health, in collaboration with general practitioners and the Coroner’s Office, has created a resource for health practitioners on determining vaccine relatedness in a death following COVID-19 vaccination: Attributing deaths to COVID-19 vaccines – a guide for medical practitioners (PDF 302 kB).

If it is unclear whether the COVID-19 vaccine has played a significant role in the person’s death, the death should be discussed with the coroner in the first instance on (07) 3738 7050 during business hours or (07) 3738 7166 after hours.

Doctors can also discuss their patient’s circumstances with a forensic physician from the Queensland Health Clinical Forensic Medicine Unit during business hours on (07) 3405 5755 or after hours on (07) 3722 1300.”

This does not replace the requirement for a death to be reported to Queensland Health using the AEFI reporting process under the Public Health Act 2005.