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watchdog Eight unusual blood clots reported in Irish people who received AstraZeneca vaccine

All patients have since recovered, health chiefs said


AstraZeneca vaccine

AstraZeneca vaccine

AstraZeneca vaccine

The medicines’ watchdog received eight reports of suspected unusual blood clots in people who received an AstraZeneca vaccine by July 7.

In its safety update the Health Products Regulatory Authority (HPRA) got 11 reports of suspected inflammatory heart condition in people who received the Pfizer or Moderna vaccines.

All the people involved in the suspected cases after the three vaccines subsequently recovered.

The HPRA said the benefits of vaccination outweigh the small risks. All reports of suspected side effects do not mean the vaccine caused them.

In all it got 11,445 reports of suspected side effects to Covid-19 vaccines since the vaccination roll-out started in December

By July 7 over 4 million doses of vaccines had been administered here.

In the case of the AstraZeneca vaccine, it said the reported syndrome involves an unusual combination of thrombosis (blood clots) with thrombocytopenia – an abnormally low level of the components that help blood to clot, known as platelets.

“Vaccine recipients are reminded to seek immediate medical attention if they experience any of the following signs and symptoms: shortness of breath, chest pain, leg swelling, leg pain, persistent abdominal pain post vaccination, severe or persistent headaches, blurred vision, confusion, seizures (fits) or bruising beyond the site of vaccination after a few days,” the HPRA said.

As of July 7, the HPRA said it had received eight reports that are suspected cases which describe the unusual combination of blood clotting in combination with low platelets.

The suspected cases occurred between one and five weeks of vaccination with the first dose.

The types of symptoms reported include shortness of breath, severe and/or persistent headache, unusual skin bruising, abdominal pain, leg pain and leg swelling.

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Cases occurred in both males and females, with a median age of 49 and an age range of 29 to 63 years.

In a small number, blood clots occurred in unusual locations, including in the brain – cerebral venous sinus thrombosis (CVST) - and liver – hepatic and portal veins.

“Based on information currently available, the individuals are either discharged or recovering in hospital after receiving specialist medical care,” the HPRA said.

In the case of Pfizer and Moderna vaccines the suspected side effect related to myocarditis and pericarditis which are inflammatory conditions of the heart that can affect anyone at any age, and often are related to an immune disease or recent viral infection, such as Covid-19 infection.

Symptoms can vary but often include breathlessness, a forceful heartbeat that may be irregular and chest pain.

Most people who experience these conditions recover with rest and standard medical treatment, but occasionally, there can be serious complications.

The European Medicines Agency's safety committee undertook a review of very rare reports.

Based on the available evidence they concluded that they should be listed as new side effects.

The frequency is as of yet unknown. Symptoms include include breathlessness, a forceful heartbeat that may be irregular, and chest pain.

In the 11 suspected cases here, six occurred after the first dose and five after the second dose, with all occurring within 14 days of vaccination.

Cases were reported in both males and females, with a median age of 56 years.

In reports received worldwide, cases have occurred more often after the second dose, and in younger adult men.

“All reports of myocarditis and pericarditis notified to the HPRA are carefully reviewed, and in a number of cases, possible alternative explanations – other than vaccination - for the individual developing the condition were described, or the diagnosis was not yet finalised at the time of reporting. In most cases, the individuals were reported to have recovered or were recovering with symptoms ongoing in some,” the HPRA said.

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