Adverse event following COVID-19 vaccination

Adverse Events of Special Interest, as well as serious, unexpected or uncommon Adverse Events Following Immunisation (AEFI), must be reported for all COVID-19 vaccines as they are notifiable conditions under the Public Health Regulation 2018 (Schedule 1).

In Queensland, health providers are required to report COVID-19 Adverse Events Following Immunisation (AEFI) to Queensland Health. Queensland Health then reports the AEFI to the Therapeutic Goods Administration (TGA) Medicines Regulation Division.

Reporting a COVID-19 AEFI

All health providers including General Practitioners (GPs) who were previously using specified practice software, and consumers, must report a COVID-19 AEFI using the COVID-19 AEFI PDF form. This enables vaccine safety issues to be identified and managed appropriately and promptly.

To complete the COVID-19 Adverse Events Following Immunisation Reporting Form (PDF 189 kB).

• Download the PDF fillable form and enter the information.

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

After entering the required information, click the Email button. The Email button will automatically attach the PDF document to an email and populate the “To:” field with CDIS-NOCS-Support@health.qld.gov.au and then the email is ready to send. Alternatively, the completed PDF can be saved, scanned, and sent to CDIS-NOCS-Support@health.qld.gov.au or printed and faxed to (07) 3328 9434.

For more information and advice, contact your local public health unit.

The Queensland Adult Specialist Immunisation Service (QASIS) at the Royal Brisbane and Women’s Hospital provides vaccination advice for people aged 16 years and over with complex medical conditions, as well as those who have experienced or are at risk of, an adverse event following immunisation. Individuals can be referred to QASIS by a health professional with a provider number, including your treating doctor, GP, Midwife or Nurse Practitioner.

For children under the age of 16 years, vaccination should be discussed with the Queensland Specialist Immunisation Service (QSIS) located at Queensland Children’s Hospital, see the Queensland Specialist Immunisation fact sheet.

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 VAE 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 download and complete this Queensland Health Vaccine Administration Error (VAE) reporting form (PDF 1121 kB) and return by email to your local public health unit.

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 death occurs in hospital, the deceased person is to remain in the hospital morgue pending further advice from the Coroners Court. If the person dies in the community, the deceased person 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 a person’s death was a direct result of the COVID-19 vaccine, the death should be discussed with the coroner in the first instance on telephone (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 on telephone (07) 3405 5755 during business hours or (07) 3722 1300 after hours.

Reporting a death to the coroner 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.