Adverse event following immunisation
An Adverse Event Following Immunisation (AEFI) as described by the online Australian Immunisation Handbook is any negative reaction that follows vaccination. It does not necessarily have a causal relationship with the vaccine.
The adverse event may be any:
- unfavourable or unintended sign
- unfavourable or unintended symptom
- abnormal laboratory finding
These events may be caused by the vaccine(s) or may occur by chance (that is, the event would have occurred regardless of vaccination).
Mild events, such as fever, pain or redness at the site of injection, tiredness and aches and pains commonly occur after vaccination with some vaccines and should be anticipated.
Under the Public Health Act 2005 and the Covid-19 Vaccination Code, Covid-19 vaccine service providers are required to report any AEFI directly to Queensland Health. Reporting an AEFI is an important part of surveillance to monitor vaccine and immunisation program safety.
For COVID-19 AEFI's please see Reporting a COVID-19 AEFI. For all other AEFI's please see Reporting AEFI's for all other vaccines.
Reporting a COVID-19 AEFI
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.
Depending on the type of health provider, there are two ways for Adverse Events Following Immunisation (AEFI) for COVID-19 Vaccinations to be reported to Queensland Health:
Queensland Health employees only
Queensland Health-controlled COVID-19 vaccination service providers (this includes all Queensland Health employees and contractors providing vaccination services) must use the COVID-19 AEFI Portal to report AEFIs. Other Queensland Health employees and contractors can also use the COVID-19 AEFI Portal to report AEFIs.
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 (GPs, 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 Therapeutic Goods Administration (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 vaccinated when they received their vaccination.
Queensland Health Vaccine Control Centre Post COVID-19 vaccination Suspected Anaphylaxis follow-up form (PDF 445 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 a Queensland Health COVID-19 vaccine Adverse Event Following Immunisation form (PDF 2410 kB)
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 may occur rarely, the TGA closely monitors for specific adverse events known as ‘adverse events of special interest’. A list of these adverse events of special interest can be found in this document.
Deaths reportable to the coronerForm 1A Medical practitioner report of a death to a 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.
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.
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.
Reporting AEFI's for all other vaccines
Notify Queensland Health by completing an Adverse Events Following Immunisation Reporting Form (PDF 189 kB).
You do not need to complete a Therapeutic Goods Administration (TGA) form. Queensland Health will notify the TGA to enable national monitoring and reporting of AEFI in Australia.
Contact your local public health unit.