Question Number: 115
PDR Number: SQ22-000122
Date Submitted: 24/02/2022
Department or Body: Department of Health

Question 114

Cardiac arrest and cardiomyopathy are not recognised side effects of the COVID-19 vaccines provisionally approved in Australia. This is because there is not currently evidence that the vaccines cause these conditions. The published case reports to date are insufficient evidence for a link between vaccination and these conditions. Please also refer to response to SQ22-000111.

Questions 174, 175, 245

The Therapeutic Goods Administration (TGA) does not disclose details relating to individual adverse event reports to protect patient confidentiality. The TGA’s assessment of reports involves consideration of sensitive information about individuals that may lead to their identification.

The TGA’s ongoing monitoring based on local and global safety data shows that the benefits of the COVID-19 vaccines continue to outweigh the risks. Like other regulators and public health bodies around the world, the TGA has not identified a signal for sudden or unexpected death in teenagers or children following COVID-19 vaccination.

Reporting of an adverse event to the TGA does not mean that the reporting doctor considers that the event was caused by vaccination. The TGA encourages reporting of all significant adverse health events following vaccination, even if there is only a small chance that they were caused by the vaccine. Under state and territory regulations in New South Wales, Western Australia, Queensland, Northern Territory and the Australian Capital Territory it is mandatory for health professionals to report adverse events following immunisation. As the number of people being vaccinated has increased, so has reporting of fatal events with a coincidental association with vaccination.

The TGA assesses individual adverse event reports with a fatal outcome to assess whether there is evidence that the vaccine could have contributed to the reported cause of death, which may indicate a new safety concern for the vaccine requiring investigation. If a death is referred to a coroner, the TGA may need to wait for the outcomes of coronial processes to complete its assessment of a fatal case.

The considerations for individual causality assessments are included in the response to question 27 (SQ22-000104). Reasons for a case to be assessed as inconsistent with a causal association to immunisation include evidence for other causes of an event that resulted in death, a lack of other evidence for a link between a vaccine and an event, or a body of published evidence against a causal association between a vaccine and an event.

However, at an individual level it may not be possible to establish a definite causal relationship between a particular adverse event and a particular vaccine on the basis of a single adverse event report. Causality assessments may result in a finding of ‘indeterminate’. Regardless of the outcome of the individual causality assessment, the TGA includes fatal adverse event reports in analyses to identify and investigate signals.