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08th Apr 2021

First Irish blood clot case after AstraZeneca vaccine being investigated

Stephen Porzio

Thankfully, the woman is said to be making a recovery.

The Health Products Regulatory Authority (HPRA) has confirmed it is investigating the first case in Ireland of a very rare blood clot in a person after receiving the AstraZeneca Covid-19 vaccine.

It comes after the Irish Times reported that a 40-year-old Dublin woman is being treated at the Mater Hospital for cerebral venous sinus thrombosis (CVST), a blood clot in the brain, after receiving the jab.

The European Medicines Agency concluded yesterday that CVST, as well splanchnic vein thrombosis – a blood clot in the abdomen – should be listed as “very rare” side effects of AstraZeneca’s vaccine.

The Irish Times says the woman is in recovery and is expected to be discharged from the Mater in the next few days.

This is after she spent one week in a stroke ward at the hospital.

Dr Lorraine Nolan, chief executive of the HPRA, said at Thursday’s Department of Health briefing: “Today, we received into our database one case report of what we would term a case of ‘special interest’ and that’s because it describes a CVST.

“At this point, as a case of special interest, it obviously will receive our utmost priority.

“We are following up in terms of the details of that specific case to get a clearer clinical picture of exactly what is happening with the individual in question.”

She added: “It’s not possible for me to say at this stage if it fits the exact profile of these rare blood clotting events that have been the subject of the EMA review.

“I also do know the Irish Times covered it this evening in terms of a report that the individual in question is making a recovery and is expected to be discharged from hospital soon.

“That is very promising in relation to this issue.”

On Wednesday, the EMA concluded that unusual blood clots should be listed as a “very rare” side effect of AstraZeneca’s Covid-19 vaccine.

A review was undertaken by the EMA after some countries reported blood clots in a small number of people inoculated with the vaccine.

The EMA’s safety committee carried out an in-depth review of 62 cases of clots in the brain and 24 cases of clots in the abdomen as of 22 March, of which 18 were fatal.

The cases came mainly from reporting systems in the European Economic Area and the UK, where around 25 million people have received the vaccine.

Despite their conclusion, the EMA has reaffirmed the benefits of the vaccine continue to outweigh the risks for people who receive it.

So far, most of the blood clot cases reported have occurred in women under 60 years of age within two weeks of vaccination, though – based on the currently available evidence – the EMA has not confirmed any specific risk factors.

The EMA is urging healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots, combined with low levels of blood platelets, occurring within two weeks of vaccination.

People who have received the vaccine should seek medical assistance immediately if they develop symptoms of this combination.

These include shortness of breath, chest pain, swelling in the legs, persistent belly pain, severe and persistent headaches, blurred vision, and tiny blood spots under the skin beyond the site of injection.

By recognising the signs and treating them early, healthcare professionals can help those affected in their recovery and avoid complications, the regulator noted.

The National Immunisation Advisory Committee (NIAC) is meeting Thursday and Friday to assess if new guidelines around AstraZeneca’s vaccine should be implemented in Ireland.

Speaking on Thursday night, Deputy Chief Medical Officer Dr Ronan Glynn confirmed there has been discussions between NPHET, the HPRA and NIAC over the issue.

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