Since the beginning of the vaccine rollout to 10 Feb, 2022, over 51.1M doses of COVID-19 vaccines have been given. The TGA has found 11 reports of death that were caused by vaccination from 762 reports received and reviewed.
Vaccine safety in children and adolescents
The TGA is closely monitoring reports in people aged under 18 years.
To 6 February 2022, we have received about 3,400 reports from approximately 3.3 million doses of Comirnaty (Pfizer) and Spikevax (Moderna) in 12-17 year olds. The most commonly reported reactions are chest pain, headache, dizziness, nausea and fever.
The TGA is also closely monitoring adverse event reports in 5-11 year olds. To 6 February 2022, we have received 523 reports from approximately 1 million Comirnaty doses administered in this age group. The most common reactions reported included chest pain, vomiting, fainting, nausea and fever.Â
VACCINATION ERRORS
Since the beginning of the rollout of Comirnaty (Pfizer) in this age group, the TGA has received 42 reports of vaccination errors in 5-11 year olds. Most of these are dosing errors in children aged 10 or 11 years old who received an adult dose of the vaccine by mistake, but there are also a few reports in younger children. 4 reports contained an adverse event - these were common and expected reactions including fever, headache and injection-site reactions.
Booster Doses
The TGA is monitoring the safety of booster vaccine doses. It is not expected that the types of side effects will be different to first and second vaccine doses based on the results of clinical trials, and observations from regulators overseas where more booster doses have been given.
To 6 February 2022, approximately 9 million boosters or third doses have been administered in Australia. The TGA have received approximately 2,840 reports of suspected adverse events identified as a third or booster dose.
The most common adverse events reported to the TGA following a booster dose are swollen lymph nodes (also called lymphadenopathy), headache, fatigue, muscle pain and fever.
Deaths following vaccination
Since the beginning of the vaccine rollout to 6 February 2022, about 51.1 million doses of COVID-19 vaccines have been given. The TGA has identified 11 reports where the cause of death was linked to vaccination from 762 reports received and reviewed.
AusVaxSafety - a national survey on COVID-19 vaccine safety
Results are given for everyone who has taken the survey, which is almost 6 million Australians so far. Data is presented for each vaccine and for the first, second and third or booster doses. Vaccine safety data is also given for subgroups of the population including:
Myocarditis
To 6 February 2022, the TGA has received 446 reports which have been assessed as likely to be myocarditis from about 34.2 million doses of Comirnaty (Pfizer) and 50 reports which have been assessed as likely to be myocarditis from about 3.2 million doses of Spikevax (Moderna).
Myocarditis is more commonly reported after the second dose in:
teenage boys (11 cases per 100,000 Comirnaty doses and 15 cases per 100,000 Spikevax doses) and
men under 30 (7 cases per 100,000 Comirnaty doses and 13 cases per 100,000 Spikevax doses)
VACCINE HESITANCY
VACCINATIONS
BY AGE GROUP
Useful links
TGA approves Comirnaty (Pfizer) vaccine) for 5–11 year olds – 5 December 2021 AusVaxSafety COVID-19 vaccine symptom checker Database of Adverse Event Notifications (DAEN)
