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A breakdown of the weekly vaccine-side effects report from the Therapeutic Goods Administration.
Every week, the Therapeutic Goods Administration (TGA) releases a summary of all reported adverse events that happen following a COVID-19 vaccination. Along with this, the TGA continuously monitors the administration of medicines and vaccines.
The reports are long and can be very dense, so Cosmos breaks them down into bite-sized pieces.
Report date: 9th September 2021
Total amount of vaccines administered to date: 20.9 million
Pfizer: 10.7 million
AstraZeneca: 10.2 million
What are some of the most common vaccine side-effects on the list?
We highlighted side-effects that occurred at a rate above 20 events per 100,000 doses. The most common side-effects on the list were headache, fever, joint and muscle pain, nausea and chills.
In total, there have been 22,180 reports of adverse events following Pfizer, at a rate of 200 reports per 100,000 doses, or 0.2 per cent.
The most common side-effects reported were headache, sore muscles and joints, injection site irritation, nausea, fever, fatigue and chills.
|Reported Event||Total Reports||Reports per 100,000 doses|
|Myalgia (Muscle pain)||4,283||34.5|
|Injection site reaction||3,335||26.9|
|Arthralgia (joint pain)||2,557||20.6|
There have been 34,659 reports of events following AstraZeneca, at a rate of 340 reports per 100,000 doses, or 0.34 per cent. Of these, the most common side-effects reported were headache, sore muscles and joints, injection site irritation, nausea, fever, fatigue and chills.
|Reported Event||Total Reports||Reports per 100,000 doses|
|Myalgia (Muscle pain)||7,435||60.0|
|Injection site reaction||4,212||34.0|
|Arthralgia (joint pain)||4,308||34.7|
How common are severe vaccine side-effects?
Pfizer – Heart inflammation
To date, there have been 370 reports of suspected myocarditis or pericarditis – inflammation of the heart – at a rate of 3 per 100,000 doses – or .003 per cent.
Of these, 12 were in children aged 15 – 17, after either the first or second Pfizer dose.
These conditions typically occur within 10 days of vaccination, but more so after the second dose, but it is more common in younger men.
While some patients have required hospital treatments, there have been no reported deaths due to heart inflammation following Pfizer administration.
AstraZeneca – Blood clots
There have been a total of 132 reported cases of thrombocytopenia syndrome (TTS), or blood clots. Of these, 74 were confirmed to have been caused by the vaccine, and 58 were considered probably caused by the vaccine.
Cases were considered probable but not confirmed when the clot occurred more than 50 days after vaccination, after which it becomes difficult to establish a link. These cases will continue to be investigated, and can account for some changes in total confirmed cases.
Despite this, blood clots are very rare.
TTS occurred at a rate of 1.6–2.9 per 100,000 doses, depending on age. The highest rate of incidence (2.9 per 100,000) occurred in people aged 50–59, followed by people below age 50 or between 70–79 (2 per 100,000).
Overall, the reports state that there have been eight deaths linked to TTS following the first dose of AstraZeneca.
The chart below shows the age breakdown of TTS occurrence:
|Age||Total cases||Cases per 100,000 doses||Tier 1* cases||Tier 2**
Tier 1* = clots in an unusual location (such as the brain or abdomen) and a low platelet count with or without antibodies that activate platelets (anti-PF4 antibodies)
Tier 2** = clots found in common locations (such as the leg or lungs) and a low platelet count and anti-PF4 antibodies
What are the symptoms of blood clot?
TTS typically occurs 3–30 days following vaccination with AstraZeneca, and most commonly presents at two weeks. Typical symptoms include persistent headache, blurred vision, drowsiness, chest pain, swelling in the legs and persistent belly pain.
Furthermore, women are more likely to develop a TTS in a problematic area, such as the brain, than men. Because of this more women have died from a TTS.
Worried? Ask your doctor about your risk of vaccine side-effects.
How many people have died from a vaccine in Australia?
According to the report, there have been nine vaccine-related deaths, all of which occurred after the first AstraZeneca dose. Of these, eight were cases of thrombocytopenia syndrome (blood clot) and one was a case of immune thrombocytopenia (excessive bleeding due to low platelet count).
Altogether, there was a total of 516 deaths in vaccinated people within three months of vaccine administration, but after review, only nine were found to have been likely due to the vaccine.
Consequently, the rest were from unrelated causes and coincidentally happened during the timeframe of three months they were monitored.
Additionally, most of the deaths following vaccination occurred in people over the age of 65.
Why are there so many reports of vaccine side-effects?
The adverse effects following administration include ANY medical event reported. In the extended list, reported events within three months of administration include foot fracture, tongue injury, yeast infection, indifference and impatience, and tinea.
The culmination of all reported incidents inflates the total number, because this is all reported events, not all vaccine-caused events.
Do the benefits of vaccination outweigh the risks of COVID-19?
On September 7, there were 24,860 active COVID-19 cases in NSW, of which 1,067 were in hospital, of which 200 were in ICU. This means 4,700 people in hospital per 100,000 active cases, and eight people in ICU per 100,000 active cases.
In Victoria on the same day, there were 1,786 active cases and 92 in hospital, or which 26 were in ICU. This puts the rate of hospitalisation at 5,100 per 100,000.
In Australia, the deathrate for closed COVID-19 cases (either recovered or died) is approximately 2,900 per 100,000, or ~3 per cent, although deathrate is directly linked to medical services available, dominant variant, vaccination rates and age.
What are the long-term vaccine side-effects?
A well-established body of evidence shows that vaccine side-effects present themselves very quickly, typically within two months. The TGA monitors for three months to be conservative.
The World Health Organisation states that ‘Severe or long-lasting side effects are extremely rare’.
Need more information?
- A brief history of vaccines
- What does 80% vaccination coverage mean?
- COVID-19 and women
- What’s with COVID-19 “breakthrough infections”?
- How well will our vaccines hold up against Delta?
- COVID-19 vaccines for young children?
- Explainer: Moderna vaccine approved in Australia
- What’s in a COVID vaccine?
This article was originally published on Cosmos Magazine and was written by Deborah Devis. Deborah Devis is a science journalist at Cosmos. She has a Bachelor of Liberal Arts and Science (Honours) in biology and philosophy from the University of Sydney, and a PhD in plant molecular genetics from the University of Adelaide.