AstraZeneca issues guidance to patients on symptoms of ‘very rare’ potential vaccine side-effect

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Guidance from the company was issued to Irish medics yesterday.

ASTRAZENECA HAS ISSUED guidance to patients who may experience a “very rare” potential side-effect from its Covid-19 vaccine.

A letter sent by the company to Irish healthcare professionals yesterday contains advice about what to do if patients experience symptoms linked to thrombosis and thrombocytopenia.

It follows a number of reports earlier this month of cases involving thrombosis in patients who had been administered the company’s vaccine in European countries.

The vaccine has since been deemed safe following investigations by the European Medicines Agency (EMA).

However, the company has formulated guidance for Irish patients as a precaution, in agreement with the EMA and the Health Products Regulatory Authority (HPRA).

The guidance notes that the benefits of the vaccine outweigh the “very rare” risk of potential blood clots with low blood platelets after a patient has received it.

However, AstraZeneca urges healthcare professionals and patients should be alert to the symptoms of thromboembolism and or thrombocytopenia as a precaution.

Those who have been vaccinated with the company’s vaccine are told to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, persistent abdominal pain following vaccination.

Those with neurological symptoms including severe or persistent headaches and blurred vision after vaccination, or who experiences skin bruising beyond the site of vaccination after a few days, are also told to seek “prompt medical attention”.

Healthcare professionals are likewise told to report any suspected adverse reactions associated with the use of the vaccine in accordance with national reporting guidelines.

A spokesperson for AstraZeneca said that an investigation by the EMA’s Pharmacovigilance Risk Assessment Committee had found no increase in the overall risk of blood clots in patients who had been given the vaccine.

“Analysis of AstraZeneca’s safety database on tens of millions of records for Covid-19 Vaccine AstraZeneca did not show that these events occurred any more commonly than would be expected naturally in millions of people,” a statement said.

“Patient safety remains AstraZeneca’s highest priority and the company has robust processes in place for the collection, analysis and reporting of adverse events and these are shared with regulatory authorities around the world.”

Countries across Europe, including Ireland, paused use of the vaccine for a number of days earlier this month after the Norwegian Medicines Agency reported serious side-effects in four patients.

Officials in Ireland had said the decision to pause the use of the vaccine had been made on a precautionary principle.

However, both the EMA and the National Public Health Emergency Team (NPHET) recommended that the use of the vaccine should continue after a conclusion by the former that the vaccine is “safe and effective”. 

Professor Karina Butler of Ireland’s National Immunisation Advisory Committee (NIAC) described reports of thrombosis as small in number and “very rare adverse events”.

“Because COVID-19 can be so serious and is so widespread, the EMA found that the benefits of this vaccine outweigh the risks of these very rare events,” she said.

“The public should be reassured by the fact that over 20 million doses of this vaccine have been given in the EEA and the UK providing protection to those who have received it.”

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Data published by the State’s medicines watchdog the Health Products Regulatory Authority (HPRA) this evening showed that ten people who have received the vaccine in Ireland so far have reported clotting.

However, the watchdog said that none of the reports notified described the type of blood disorder associated with concerns about the AstraZeneca vaccine.

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