COVID-19 vaccine weekly safety report - 09-12-2021

Reported side effects for COVID-19 vaccines

The most frequently reported side effects suspected to be associated with the vaccines include injection-site reactions, such as a sore arm, headache, muscle and joint pain, fever and chills.

The TGA is closely monitoring reports in people aged under 18 years. To 5 December 2021, we have received about 2,600 reports after vaccination with Comirnaty (Pfizer) and Spikevax (Moderna). The most commonly reported reactions are:

• chest pain
• dizziness
• headache
• nausea
• fever.

Booster doses

The TGA is monitoring the safety of booster vaccine doses. It is not expected that the type 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.

The Comirnaty (Pfizer) and Spikevax (Moderna) vaccines are now approved for use as booster doses in adults. For people who are immunocompromised, a third dose is given as part of their primary vaccine course. This is given 2–6 months after their second vaccine dose and is not considered to be a ‘booster’. For everyone else, booster doses are recommended 6 months after completing their primary course of 2 doses.

To 5 December 2021, we have received approximately 220 reports of suspected adverse events for reports identified as a third or booster dose Comirnaty (Pfizer). As the number of reports is so low, it is too early to detect any trends or patterns in the data. However, we will report any emerging safety concerns if they arise.

A national survey by AusVaxSafety, which collects responses from individuals after they have received a COVID-19 vaccine, has found that the types of reactions experienced after a third or booster dose of Comirnaty (Pfizer) are very similar to those experienced after first and second doses. However, more people reported an adverse event after a third or booster dose (58%) than after a first or second dose (36% and 53% of respondents).

Local reactions like pain, redness, swelling and itching at the injection site were more common after a third or booster dose (49% of respondents) than after a first or second dose (30% and 42%). Other more general symptoms like fatigue, headache, muscle and joint pain and fever occurred at a similar rate after a third or booster dose and a second Comirnaty (Pfizer) dose. These findings are consistent with results from safety monitoring of additional vaccine doses in the US.

More details and results from this survey can be found on the AusVaxSafety website.

Reports of death in people who have been vaccinated

Large scale vaccination means that some people will experience a new illness or die within a few days or weeks of vaccination. These events are often coincidental, rather than being caused by the vaccine. As the number of people being vaccinated has increased, so has reporting of fatal events with a temporal association with vaccination. Review of these individual reports and patterns of reporting does not suggest that the vaccines played a role in the vast majority of these deaths.

The TGA closely reviews all adverse events after COVID-19 vaccination where a fatal outcome is reported. Read last week’s report for details of this process. Since the beginning of the vaccine rollout to 5 December 2021, over 39.6 million doses of COVID-19 vaccines have been given. The TGA has identified 11 reports of death that were linked to vaccination from 700 reports received and reviewed. The deaths linked to vaccination occurred after the first dose of Vaxzevria (AstraZeneca) – 8 were thrombosis with thrombocytopenia syndrome (TTS) cases, 2 were linked to Guillain Barre Syndrome (GBS) and one was a case of immune thrombocytopenia (ITP).

Of the 700 deaths reported to the TGA, over 75% occurred in people aged 65 years and older. A very small number of deaths have been reported in individuals under 35 years of age, including 2 adolescents. Only one death reported in a younger person has been linked to vaccination – this was in a 34-year-old woman who died as a result of TTS.

Outcomes of Vaccine Safety Investigation Group meeting - 7 December 2021

The TGA convened an external expert group to review reports of serious adverse events following COVID-19 vaccination in 5 people. This was to determine whether the events were related to vaccination. Sadly, 4 of these cases were fatal and the TGA extends its sincerest condolences for the individuals and their loved ones. The group included experts in infectious diseases, haematology, respiratory medicine, immunology, cardiology and neurology, as well as a consumer representative and an expert in communication and public health. The cases were reported to the TGA over the previous few months and had been under investigation by the TGA in collaboration with local health authorities. During this time, the TGA gathered additional information needed to accurately assess these cases, including post-mortem reports and other medical investigations. We convened the expert Group as soon as sufficient information was available.

The expert panel uses an internationally-accepted method developed by the World Health Organization to rate the level of certainty of a link between the event and a vaccine. The medical conditions that were reported in these cases — Guillain-Barre Syndrome (GBS), myocarditis and multisystem inflammatory syndrome — can all have causes other than vaccination. Therefore,  detailed information about the cases was needed for the panel to undertake a meaningful assessment of the possible role of vaccination.

The cases considered were:

• 2 fatal cases of suspected Guillain-Barre Syndrome (GBS) following vaccination with Vaxzevria (AstraZeneca).
• 2 fatal cases of suspected myocarditis following Comirnaty (Pfizer)
• one case of suspected multisystem inflammatory syndrome following Comirnaty (Pfizer).

The VSIG came to the following conclusions:

• Both GBS cases appeared likely to be related to vaccination but there was still uncertainty with this determination given the complexity of the syndrome and of the case reports. Further detail on the discussion of these cases is provided below.
• The myocarditis cases were not consistent with being caused by vaccination. Further information is provided in the myocarditis section below.
• For the suspected case of multisystem inflammatory syndrome, there was not enough medical information to determine if it was related to the vaccine. While the symptoms started near to the time of vaccination, there was insufficient information to diagnose multisystem inflammatory syndrome and establish a possible link to vaccination.

The TGA will continue to monitor reports of similar events and will discuss the outcomes of these reports with international regulatory agencies.

Comirnaty (Pfizer) mRNA vaccine

To 5 December 2021, about 24.8 million doses of Comirnaty (Pfizer) have been administered in Australia.

The TGA is actively investigating reports of myocarditis (inflammation of the heart) and/or pericarditis (inflammation of the membrane around the heart) associated with mRNA vaccines. Two fatal cases of an unusual form of myocarditis following a dose of Comirnaty (Pfizer) were considered by an expert group on 7 December 2021. The group determined that both cases were not consistent with being caused by vaccination. We continue to work with international regulators on this safety signal (see below).

Up-to-date information for Comirnaty (Pfizer), including details of potential side effects, can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).

Spikevax (Moderna) mRNA vaccine

To 5 December 2021, about 1.3 million doses of Spikevax (Moderna) have been administered in Australia. The TGA provisionally approved the use of Spikevax (Moderna) as a booster dose on 8 December 2021.

The TGA is actively investigating reports of myocarditis (inflammation of the heart) and/or pericarditis (inflammation of the membrane around the heart) associated with mRNA vaccines. We continue to work with international regulators on this safety signal (see below).

The PI for Spikevax (Moderna) has been updated to include the potential adverse events erythema multiforme (frequency not known), and paraesthesia and hypoaesthesia (both listed as rare). These events were not observed in the clinical trials, but have been reported during post-market surveillance.

The following wording about the frequency of myocarditis has also been added to the PI:

‘The increased risk of myocarditis after vaccination with Spikevax is highest in younger males (see section 4.4). Two large European pharmacoepidemiological studies have estimated the excess risk in younger males following the second dose of Spikevax. One study showed that in a period of 7 days after the second dose, there were about 1.316 (95% CI 1.299 – 1.333) extra cases of myocarditis in 12- 29-year-old males per 10,000 compared to unexposed persons. In another study, in a period of 28 days after the second dose, there were 1.88 (95% CI 0.956 – 2.804) extra cases of myocarditis in 16- 24-year-old males per 10,000 compared to unexposed persons.’

Up-to-date information for Spikevax (Moderna), including details of other potential side effects, can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).

Vaxzevria (AstraZeneca) vaccine

To 5 December 2021, about 13.6 million doses of Vaxzevria (AstraZeneca) have been administered in Australia.

The TGA is closely monitoring rare reports of blood clots with low blood platelets (also called thrombosis with thrombocytopenia syndrome or TTS) linked to this vaccine. We are also monitoring reports of immune thrombocytopenia (ITP) and Guillain-Barre Syndrome (GBS). See below for more details. Two fatal cases of GBS following a dose of Vaxzevria (AstraZeneca) were considered by an expert group on 7 December 2021. The group determined that both cases were consistent with being caused by vaccination. See below for more details.

Up-to-date information, including details of these and other potential side effects can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).

Myocarditis and pericarditis with mRNA vaccines

The Australian Technical Advisory Group on Immunisation (ATAGI) continues to emphasise that the protective benefits of the mRNA vaccines far outweigh the rare risk of these side effects in all eligible age groups.

ATAGI advises that people who develop myocarditis attributed to their first vaccine dose should defer further doses of an mRNA COVID-19 vaccine and discuss this with their treating doctor.

For those with suspected pericarditis after a first dose, future dose recommendations depend on test results and the person’s age and sex. Refer to expert Guidance on myocarditis and pericarditis after mRNA COVID-19 vaccines for more information.

What are myocarditis and pericarditis?

Myocarditis is inflammation of the heart, and pericarditis is inflammation of the membrane around the heart. They can occur as rare adverse events after vaccination with the mRNA vaccines Comirnaty (Pfizer) and Spikevax (Moderna).

When do they occur?

Cases typically occur within 10 days, with symptom onset often within 5 days of vaccination. Our analysis indicates that most of the patients with likely myocarditis experienced symptoms within 3 days of vaccination.

How common are they?

In Australia, myocarditis is reported in 1–2 out of every 100,000 people after receiving the Comirnaty (Pfizer) vaccine.

In some countries, higher rates of myocarditis and pericarditis have been reported with Spikevax (Moderna) than with Comirnaty (Pfizer). Because the number of cases of myocarditis reported after Spikevax (Moderna) in Australia is small, at this stage we are not able to calculate reliable reporting rates for it or to see any difference in risk between the 2 vaccines.

In Australia, the current overall estimated rates (for the entire population) of myocarditis are 1.6 cases per 100,000 doses for Comirnaty (Pfizer) and 2.0 cases per 100,000 doses for Spikevax (Moderna). However, statistical analysis shows that there is more uncertainty around the reporting rate for Spikevax (likely to be between 1.4 and 2.8 cases per 100,000 doses) than for Comirnaty (likely to be between 1.4 and 1.7 cases per 100,000 doses).

Who is at risk?

Myocarditis is more commonly reported in young men and teenage boys after the second dose (8–12 cases in 100,000 people). However, even in this population it remains rare.

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (EMA PRAC) recently reviewed myocarditis and pericarditis data from teenage boys and young men (12-29 years old) in 2 large European studies. For Comirnaty, the review found there was less than 1 extra case of myocarditis per 100,000 vaccinated individuals compared to their unvaccinated counterparts. For Spikevax, 1–2 extra cases of myocarditis per 100,000 vaccinated were reported for vaccinated individuals compared to their unvaccinated counterparts.

How serious is myocarditis?

Myocarditis is commonly mild, and cases usually resolve after a few days following treatment and rest. In some people treatment in hospital is needed, with a small number of cases being more serious. Our analysis has found about half of the patients with suspected myocarditis were admitted to hospital. Twelve people with suspected myocarditis were treated in intensive care, of which 5 were classified as having likely myocarditis. Most  patients treated in hospital were discharged within 4 days.

To date, the TGA has not identified any vaccine-related deaths from myocarditis. Two fatal cases of myocarditis were not found to be related to vaccination based on the available information. This was after review by an independent Vaccine Safety Investigation Group on 7 December 2021. Both cases occurred after a first dose of Comirnaty (Pfizer) – one involved a 52-year-old man from NSW and the other was in 60-year old woman from Queensland. We extend our sincere condolences to the families and loved ones of these people.

Both people had signs of giant cell myocarditis which is a different from the type of myocarditis that has been seen in very rare cases following vaccination. In one case myocarditis occurred soon after vaccination, but the individual also had an underlying medical condition that could have caused symptoms. The timeframe of the second case, together with the clinical features, suggested myocarditis was not related to vaccination and was more likely to be due to other causes. 

The TGA is continuing close surveillance of cases like these where there is still some uncertainty. We are also working with international regulators to identify if there have been other similar cases overseas.

What symptoms should I look out for?

We encourage people to seek medical attention if they experience symptoms that could suggest myocarditis or pericarditis. This includes chest pain, palpitations (irregular heartbeat), fainting or shortness of breath, particularly if they occur within 1–5 days of vaccination.

Initial tests for those presenting with symptoms include ECG, troponin levels and chest X-ray. Brief guidance on the initial assessment of children and adolescents with symptoms has been published by the Paediatric Research in Emergency Departments International Collaborative (PREDICT) network.

What does the TGA know about myocarditis and pericarditis cases?

The number of reports of myocarditis is increasing each week, which is expected as the number of vaccine doses given also increases each week. We are closely monitoring the rates of myocarditis for all age groups and sex. While there are some fluctuations from week to week, especially in subgroups with small numbers of reports, rates of reporting of myocarditis in Australia are consistent with rates reported internationally.

Reports received by the TGA of suspected myocarditis and pericarditis for the mRNA vaccines are provided in Table 1. We have reviewed these reports against an internationally accepted criteria to classify the likelihood of myocarditis. This assessment does not determine whether cases have been caused by vaccination.

Table 1. Reports of suspected myocarditis and pericarditis received by the TGA to 5 December 2021

		Comirnaty (Pfizer) (24.8 million doses given)		Spikevax (Moderna) (1.3 million doses given)
		All cases	Cases in adolescents (12–17 years)	All cases	Cases in adolescents (12–17 years)
Suspected myocarditis cases*		786	161	51	18
Likely myocarditis†‡	Level 1	39	7	0	0
	Level 2	292	94	18	11
	Level 3	58	11	7	2
Unlikely myocarditis		155	13	7	1
Insufficient information		242	36	19	4
Suspected pericarditis cases		1688	127	94	6

*Cases reporting both myocarditis and pericarditis are included in suspected myocarditis cases.

‡ Cases classified as level 1 are confirmed to be myocarditis based on strong clinical evidence including the patient’s symptoms, and results of tests and imaging indicating a diagnosis of myocarditis. Level 2 cases are probably myocarditis based on a combination of symptoms and routine tests for heart conditions. Level 3 cases are possibly myocarditis based on symptoms and a doctor’s report that myocarditis is the most likely diagnosis in the absence of medical tests and investigations. For all cases of suspected myocarditis, where possible, other known causes of the patient’s symptoms or test results are ruled out before cases are classified.

†The youngest case classified as ‘likely myocarditis’ to date was 12 years old.

As we have received limited adverse event reports for Spikevax (Moderna), our analysis of likely myocarditis cases by age and dose focuses on data for the Comirnaty (Pfizer) vaccine (see Table 2). The estimated reporting rates in Australia appear similar to overseas rates.

Table 2. Rates of myocarditis cases (levels 1-3) following Comirnaty (Pfizer)

Age (years)	All doses		Second doses
	Rate* per 100,000 doses		Rate* per 100,000 doses
	Male	Female	Male	Female
12-17	7.2	1.6	11.8	2.7
18-29	3.8	1.3	5.9	1.9
30-39	1.6	0.7	1.5	0.6
40-49	0.8	0.7	1.1	0.9
50-59	0.4	0.3	0.1	0.4
60-69	0.2	0.3	0.0	0.0
70+	0	0.2	0	0
All ages*	2.3	0.8	3.2	1.1

*The rate includes cases of myocarditis that occurred after vaccination but may not be vaccine related. The number of younger people vaccinated is still relatively low in Australia, so estimated reporting rates are based on limited data.

We continue to monitor and review Australian data on myocarditis and will provide regular updates in this report as more information becomes available. We are also working closely with international medicines regulators to share emerging safety information.

For more information, see guidance on myocarditis and pericarditis developed by ATAGI and the Cardiac Society of Australia and New Zealand (CSANZ).

Thrombosis with thrombocytopenia syndrome

What is TTS?

Thrombosis with thrombocytopenia syndrome (TTS) is a rare but serious adverse event linked to the Vaxzevria (AstraZeneca) vaccine. People with TTS have blood clots and low blood platelets.

When does it occur?

TTS symptoms usually start between 4–30 days after vaccination. In Australia, cases of TTS have most often occurred about 2 weeks after vaccination.

How common is it?

TTS is a rare adverse event. In Australia, it occurs in about 2 out of every 100,000 people after a first dose. The risk of TTS after a second vaccine dose appears to be much lower and is estimated to be 0.3 out of every 100,000 people after a second dose.

Who is at risk?

Younger women seem to be slightly more likely to have serious outcomes from TTS as they more often experience clots in unusual locations, such as the brain or abdomen. These cases are classified as ‘Tier 1’. People under 60 years are more likely to be classified as Tier 1 and/or require treatment in intensive care.

How serious is it?

TTS can be a serious illness and most people require treatment in hospital. In a small number of people with the syndrome, it can be fatal. In Australia, the risk of dying from TTS after vaccination is about one in a million (people receiving a first dose). Of the 169 people with TTS, sadly 8 people have died from it – 6 of these were women.

What symptoms should I look out for?

It is important for people with early symptoms of TTS to get medical attention early as this may help to prevent more serious complications developing. People should seek immediate medical attention if they develop any of the following symptoms after vaccination:

• severe or persistent headache, blurred vision, confusion or seizures

• shortness of breath, chest pain, leg swelling or persistent abdominal pain

• unusual skin bruising and/or pinpoint round spots beyond the site of vaccination.

While TTS is very rare, some people may have concerns that they wish to discuss with their doctor. ‘Weighing up the potential benefits against risk of harm from COVID-19 Vaccine AstraZeneca’ includes information to help people make informed decisions about vaccination.

Where can I find more information?

Guidance for health professionals is now available which outlines when to suspect TTS, initial tests that can be performed in primary care and when to refer people for emergency care. Patients presenting with low platelets and a headache should be thoroughly investigated for blood clots in the brain, including careful review of imaging results to identify early, small clots. The Royal Australian and New Zealand College of Radiologists have published imaging recommendations for patients with suspected TTS.

What does the TGA know about the TTS cases?

From about 13.6 million vaccine doses, there have been 169 cases of TTS. Of these, 147 (83 confirmed, 64 probable) related to a first dose of Vaxzevria (AstraZeneca) and 22 to a second dose (5 confirmed, 17 probable). This includes 4 new cases of TTS reported this week (see Table 3). 

Table 3: Newly confirmed and probable TTS cases for the week of 3-9 December 2021‡ 

New confirmed TTS	New probable TTS
One case (first dose): 64-year-old woman from Queensland	Three cases (2 first dose, 1 second dose): 62 and 64-year-old men from Victoria 62-year-old man from Queensland

‡As previously reported, the TGA determines whether a report is likely to represent TTS by assessing cases against accepted criteria established by the UK’s Medicines and Healthcare products Regulatory Agency. Cases may be reclassified as further information becomes available.

When assessed against the criteria used by the US Centers for Disease Control and Prevention (CDC), approximately one-third of the cases reported to the TGA after a first dose are classified as Tier 1 (Table 4). Cases reported after a second vaccine dose are much less likely to be classified as Tier 1 with most people having clots in common locations, such as the lungs or legs. The majority of these cases occurred in people over the age of 60 years old.

 

Table 4: Australian TTS cases to date by age and CDC classification A. First dose cases

Age	Reported cases (6.9 million doses given)	Tier 1 CDC classification†	Reports per  100,000 doses‡
<30 years	8	2	2.0 (<50 years)
30-39	5	4
40-49	11	6
50-59	33	18	3.0
60-69	37	11	1.8
70-79	37	10	2.2
80+	16	4	1.9
All ages	147 (74 men, 73 women)	55 (18 men, 37 women)	2.1

 

B. Second dose cases

Age	Reported cases (6.7 million doses given)	Tier 1 CDC classification†	Reports per 100,000 doses‡
<30 years	0	0	0 (<50 years)
30-39	0	0
40-49	0	0
50-59	3	1	0.4 (≥50 years)
60-69	7	1
70-79	9	1
80+	3*	0
All ages	22 (15 men, 7 women)	3 (2 men, 1 woman)	0.3

‡ Rates of TTS are calculated as of 4 November 2021 to account for the time to onset of TTS. These rates are estimates of risk based on small numbers of cases so far. Aggregated rates are given for some age ranges where the number of cases for a 10-year age bracket is too low to calculate reliable estimates.

† The US CDC classification of Tier 1 is defined as 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).

*  A previously reported, confirmed case was identified as a duplicate report and has been removed.

Table 5: Time to onset, treatment and outcomes for TTS cases*

		First dose	Second dose
Median time to onset/ diagnosis	Median (range)	13 days (1-94)	11 days (2-69)
Treated in ICU	At any point	47	2
	Currently	0	0
Outcome†	Discharged	135	22
	In hospital	2	0
	Fatal	8	0

*Data is based on the most recent medical information available to the TGA for first and second dose TTS cases.

†As previously reported, one patient died from unrelated medical conditions while being treated for TTS. The outcome for this patient is not included in this table.

Guillain-Barre Syndrome

What is GBS?

GBS is a rare but sometimes serious immune disorder affecting the nerves and can result in pain, numbness, muscle weakness and difficulty walking.

When does it occur?

GBS can occur when the immune system is activated. It has been associated with COVID-19 and other infections and with other vaccines. GBS usually occurs days or weeks after an infection or vaccination. However, sometimes a trigger for GBS cannot be identified. The expected time period for onset of GBS symptoms is 2–42 days after vaccination.

How common is GBS?

GBS following vaccination is rare. In Australia, GBS has been reported in about one in every 100,000 people following the Vaxzevria (AstraZeneca) vaccine.

To 5 December 2021, the TGA has received 155 reports of suspected GBS occurring after vaccination with Vaxzevria (AstraZeneca). It is expected that some of these cases may not be related to vaccination, as GBS can occur after common viral infections and some types of gastroenteritis. In addition, numbers may fluctuate as duplicate cases are identified and processed.

Who is at risk from GBS?

Emerging evidence suggests that GBS may be a rare adverse event associated with Vaxzevria (AstraZeneca). There are currently no identified risk factors for GBS. However, in the general population it is more common in people aged over 60 years.

How serious is GBS?

GBS is a serious condition that can occasionally lead to death. While many cases of GBS resolve within months, recovery in some people can take years.

Two fatal cases of suspected GBS following a first dose of Vaxzevria (AstraZeneca) were reviewed by an independent Vaccine Safety Investigation Group on 7 December 2021. These involved a 77-year-old woman from Victoria and an 81-year-old woman from NSW. Sadly, both women died as a result of their symptoms and we extend our sincere condolences to their families and loved ones.

Both cases of GBS were deemed likely to be related to vaccination. This was based on the time period between vaccination and GBS developing; the absence of other identifiable causes; and evidence from international investigations of a possible link between GBS and Vaxzevria (AstraZeneca). However, there was some uncertainty around this determination because GBS occurs in people who have not received a vaccine and sometimes there is no obvious trigger identified.

What symptoms should I look out for?

We encourage people to seek medical attention if they experience symptoms that could suggest GBS as early medical care can reduce severity and improve outcomes. Symptoms to look out for include weakness, pain and paralysis in the hands or feet that can progress to the chest and face over a few days or weeks. Symptoms tend to affect both sides of the body.

What is the TGA doing?

The benefits of Vaxzevria (AstraZeneca) continue to outweigh the risks. Health professionals should be aware of the possible signs and symptoms of GBS in people who have been vaccinated to ensure correct diagnosis and so that treatment can be started early.

There is growing evidence of a possible link between GBS and Vaxzevria (AstraZeneca) following rigorous investigations of safety data by the TGA and other international regulators. In response to rare cases following vaccination, warning statements about GBS have been added to the Vaxzevria (AstraZeneca) Product Information. Further changes are expected to reflect the strengthening evidence of a possible link.

Immune thrombocytopenia (ITP)

What is ITP?

ITP is a rare immune reaction that can occur after a viral infection or a vaccine. When it occurs platelets, which help blood to clot, are mistakenly destroyed.

When does it occur?

Information from other vaccines suggest that ITP most frequently occurs within 6 weeks of vaccination.

How common is ITP?

ITP after COVID-19 vaccination is very rare. In Australia, ITP has been reported in less than one in every 100,000 people following the Vaxzevria (AstraZeneca) vaccine.

To 5 December 2021, the TGA has received 94 reports of suspected ITP following vaccination with Vaxzevria (AstraZeneca). These patients had an extremely low platelet count, and signs of thrombocytopenia which may include unusual bruising, a nosebleed and/or blood blisters in the mouth. Their symptoms occurred in a timeframe that suggested they could be linked to vaccination and no other obvious cause was identified based on the information provided to the TGA.

Who is at risk?

There are currently no identified risk factors for ITP following vaccination with a COVID-19 vaccine.  

How serious is ITP?

In many cases ITP is mild with up to a third of people having no symptoms at all, or only minor bruising. However, about 5% develop severe bleeding. In a very small number of people it can be fatal. 

In Australia, there has been one report of a fatal case of ITP linked to vaccination with Vaxzevria (AstraZeneca). Following an investigation by the TGA, the Product Information has been updated to include a warning about ITP. Apart from one previously reported fatal case that was assessed by an expert Vaccine Safety Investigation Group as being likely to be vaccine related, other suspected cases of ITP have not been definitively linked to vaccination.

What symptoms should I look out for?

We encourage people to seek medical attention if they experience signs and symptoms that could suggest ITP, such as unusual skin bruising or clusters of small red or purple spots that do not lose their colour when pressed. Unusual bleeding is another sign, for example bleeding from the nose or mouth that is hard to stop, or blood in the urine or stools.

Useful links

Australian Technical Advisory Group on Immunisation (ATAGI) weekly COVID-19 meeting update – 3 December 2021

Top 3 COVID-19 vaccine questions – Omicron worries, border restrictions, and COVIDSafe and Omicron– 2 December 2021

Top 3 COVID-19 vaccine questions – Omicron, COVID vaccine and male fertility, and unvaccinated at festivities – 30 November 2021

TGA approves Comirnaty (Pfizer) vaccine) for 5–11 year olds – 5 December 2021

Booster doses of the COVID-19 vaccines – 5 November 2021

Myocarditis and pericarditis following COVID-19 mRNA vaccines – Melbourne Vaccine Education Centre – 11 November 2021

COVID-19 vaccines: Frequently asked questions – 7 December 2021

COVID vaccines – is it true? – 4 November 2021

Vaccination among COVID-19 cases in the NSW Delta outbreak – 8 November 2021

RMIT ABC Fact Check

Latest advice on COVID-19 vaccination for pregnant and breastfeeding women – 18 August 2021

Coronavirus (COVID-19) case numbers and statistics

Australia’s COVID-19 vaccine rollout

TGA COVID-19 vaccines hub

Australian Government Department of Health COVID-19 vaccines hub

COVID vaccine information in your language

AusVaxSafety (active surveillance activities and information)

COVID-19 vaccine symptom checker

Database of Adverse Event Notifications (DAEN)

Comirnaty (Pfizer) vaccine – phase III clinical trial

Vaxzevria (AstraZeneca) vaccine – phase III clinical trial

Spikevax (Moderna) vaccine – phase III clinical trial