No deaths in latest TGA vaccine safety report

The additional cases of thrombosis with thrombocytopenia syndrome (TTS) bring the total number reported in Australia to 112 (62 confirmed, 50 probable) from the approximately 8.1 million doses of AstraZeneca administered up to 15 August.
 
Six of these cases have proved fatal, meaning only 0.000074% of AstraZeneca doses have been linked to a person dying in Australia as a result of TTS. Thirty-three people have been sent to the ICU due to TTS, with six still receiving treatment in the ICU.
 
One other death due to immune thrombocytopenia (ITP) has also been linked to AstraZeneca.
 
All but one of the new probable or confirmed TTS cases were in people aged 50 or older, with the exception being a 28-year-old woman from Queensland.
 
A further 39 cases of suspected myocarditis and/or pericarditis following Pfizer vaccination were reported to the Therapeutic Goods Administrations (TGA) between 8–15 August, taking the overall total to 188 from 7.22 million doses.
 
The TGA has received 50,597 adverse event reports from 15,341,039 doses administered (3.3/1000 doses). Injection-site reactions, such as a sore arm, remain most frequently reported side effects, along with more general symptoms such as headache, muscle pain, fever and chills.
 
The TGA has also investigated whether facial swelling can occur post-vaccination in people who have had dermal filler injections, following reports of this happening overseas.
 
‘We identified two reports with the Comirnaty [Pfizer] vaccine which involved swelling and tenderness of the cheeks, eyes and, in one of the cases, lips,’ the TGA stated.
 
‘Both individuals had received dermal filler injections in these areas previously. A reaction was also reported at a dermal filler injection site following vaccination with the AstraZeneca vaccine, but the report contained limited information about the adverse event.
 
‘After reviewing cases reports and data from the scientific literature, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee considered that there is a reasonable possibility that these side effects could be caused by the Comirnaty vaccine.
 
‘These types of reactions can be triggered by the immune system after a viral or bacterial illness, vaccinations such as the influenza vaccine, and dental procedures. Symptoms respond to treatments, such as oral corticosteroids and hyaluronidase, but often resolve on their own.’
 
Given the benefits of vaccination vastly outweigh the very small risk of these reactions, the TGA does not recommend discouraging people who have previously received injectable dermal fillers from getting vaccinated. Similarly, there is no need to avoid dermal fillers in the future for those who are already vaccinated.
 
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