COVID-19 vaccine weekly safety report - 10-03-2021

• Headache
• Nausea
• Injection site reaction
• Dizziness
• Fatigue

Adverse events reported to the TGA may not be caused by the vaccine. Learn more about causality.

Not all adverse events are reported, especially for minor and well-known side effects. Learn more about reporting levels.

The information the TGA receives in reports reflects the view of the reporter. As analysis of these reports is ongoing, the information may change as data quality is reviewed or further information is provided. Total numbers may also change as duplicate reports are identified.

Analysis of adverse event reports by product received up to and including 28 February 2021

Comirnaty BNT162b2 (mRNA) – Pfizer Australia Pty Ltd

Frequently reported adverse events

The most frequently reported adverse events for the Comirnaty vaccine were:

• Dizziness or feeling faint
• Headache
• Nausea

The occurrence of these adverse events is consistent with what is already known about the Comirnaty vaccine. Headache and nausea were commonly reported adverse reactions in clinical trials. Dizziness or feeling faint is a common reaction to vaccination that can be caused by the body’s reaction to pain or feeling anxious about an injection.

Adverse events of special interest

The TGA, like other vaccine safety monitoring programs around the world, closely monitors for specific adverse events known as ‘adverse events of special interest’. This close monitoring helps us to confirm the safety profile of COVID-19 vaccines, particularly with respect to possible side effects that may occur rarely. We conduct analyses to compare the number of reports of these events against the expected rate of events.

Adverse events of special interest reported for the Comirnaty vaccine were:

• Stroke (1 report)
• Facial weakness (1 report)

A small number of people in clinical trials of Comirnaty experienced facial weakness. Stroke is being monitored because of a theoretical link with COVID-19 disease. Our review does not suggest an increased risk of stroke, facial weakness or any other adverse event of special interest associated with the vaccine.

Further information about Comirnaty can be found in the Consumer Medicine Information.

Active surveillance

AusVaxSafety is an active vaccine safety surveillance system that complements the TGA’s enhanced safety surveillance activities. Active vaccine safety surveillance uses SMS and a short survey to collect reports of AEFI directly from a subset of people receiving the vaccines. AusVaxSafety is an Australian Government-funded system that shares its findings with the TGA to assist our safety investigations and responses.

See details of AusVaxSafety’s latest COVID-19 vaccines safety data.

The AusVaxSafety findings support the TGA’s assessment that the COVID-19 vaccines used in Australia meet safety standards.

Other TGA safety information

During the past week, the TGA has published the following COVID-19 safety-related information:

• COVID-19 vaccines – safety and effectiveness in older adults – 10 March 2021
  Data on real-world use of COVID-19 vaccines registered for use in Australia provide reassurance about the safety of their use in older people. There is also encouraging new data on the effectiveness of the vaccines in older people.

Useful links

TGA COVID-19 vaccines hub

Australian Government Department of Health COVID-19 vaccines hub

AusVaxSafety