While all vaccines are known to have various side-effects (most mild and short-lived), the newness of the COVID-19 vaccines and the lack of long-term safety data make it imperative that doctors and other medical professionals overseeing the vaccination of patients are hyper-vigilant in monitoring and reporting adverse events following immunisation (AEFI). Doing so will help to retain public trust in vaccines and public health initiatives, and ensure that those who are negatively impacted by vaccines get the recognition, research and help that they deserve.
Read the OzSAGE position statement on the importance of COVID-19 vaccination & development of better systems for management of uncommon subsequent adverse events.
A number of patients with serious adverse vaccine experiences have reported to us that their medical teams have not submitted reports to state or federal authorities. Common, and inappropriate, reasons include:
- The medical professional does not believe that the symptoms are connected with the vaccine.
- The medical professional does not have the time to submit a report.
None of these reasons is an acceptable excuse for not submitting an AEFI report, and we remind medical staff that state legislation requires that all AEFI be reported.
How to report AEFI
Medical practitioners can report AEFI through the TGA website — www.tga.gov.au/report-adverse-event-or-problem-health-professionals. This is generally the quickest method of reporting, and ensures that the information that you submit will be precisely what appears in the TGA databases.
However, during the pandemic physicians were encouraged to report AEFI via their state authorities (generally via an online or downloadable form). You only need to make a report either to the TGA or to your state authority, but not both.
|via the Therapeutic Goods Administration (TGA)
|via the ACT Health Immunisation Unit
|via your local Public Health Unit
|via the NT Centre for Disease Control
|via the Communicable Diseases Unit
|via the South Australian Vaccine Safety Surveillance System
|via the Communicable Diseases Prevention Unit
|Victoria & WA
This site requires the physician to register their details first and create their own unique password to enter the site. Other health practitioners and patients can also register and report their adverse reactions using SAFEVAC. You will be prompted to provide patient & vaccine details, dates, and a description of the vaccine adverse event with respect to timeline. This method of reporting an adverse event to vaccines through SAFEVAC can take up to 15 minutes to complete.
If you would like to explore the public AEFI reports disclosed by the TGA, the OpenDAEN website (opendaen.info) provides an easy to use interface to do so. OpenDAEN is an independent initiative of several Australian doctors and scientists, in order to make official TGA data more accessible to the public. It is not affiliated with COVERSE.