Irish regulator reports ‘less than five’ serious blood clot cases after AstraZeneca shots

A small number of serious blood clotting events in Irish people who received the AstraZeneca Covid-19 vaccine have been reported by the State's medicines regulator in its latest safety update.

The Health Products Regulatory Authority (HPRA) said it has received "less than five" reports of blood clotting-type events combined with low platelets in people who received the vaccine. All cases involved people aged under 40.

This is the same amount specified in the authority’s previous update in April.

“Symptoms occurred within one to two 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 and leg pain,” according to the report.

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“The individuals concerned were discharged from hospital after receiving specialist medical care.”

These are among a total of 41 reports of blood clotting events of all types that it has received in relation to the vaccine. This represents an increase of 12 reports since the last update.

In this wider groups of reports, the update said, the vast majority described clots typically seen in the general population, such as deep vein thrombosis in the legs and pulmonary embolism in the lungs. “In many reports, the individuals concerned had risk factors for clotting.”

Outweigh risks

A total of 7,862 reports of suspected side effects have been notified so far, arising from the administration of almost 2 million vaccine doses.

The HPRA said the vast majority of side effects from the vaccines are mild to moderate in nature, and that the benefits of Covid-19 vaccines continue to outweigh the risks.

The AstraZeneca vaccine accounts for slightly more than half of the reports made to the HPRA so far, but only 28 per cent of vaccine doses administered in Ireland.

Use of the AstraZeneca vaccine in Ireland is restricted to over-50s due to the very rare clotting issue, but the Health Service Executive is looking at how it could be given to people in their 40s under certain conditions following a recommendation to this effect from the National Immunisation Advisory Committee.

The HPRA said eight reports of anaphylaxis, a serious allergic reaction, have been received from people who were administered the Pfizer vaccine. All were reported to have recovered.

Less than five anaphylaxis reports were received from people who had received the AstraZeneca or Janssen vaccines.

A total of 56 reports have been received about a person who was immunised and then died. Fifty of these involved mRNA vaccines (Pfizer and Moderna).

“The types of events reported mainly include fatalities often seen in the general population, such as those due to natural causes, progression of underlying disease. In some cases, the individuals concerned tested positive for Covid-19,” according to the HPRA.

While the deaths were being reviewed, this does not mean they were caused by the vaccine, it said.

* This article was amended on May 21st, 2021