Medicines regulator investigates first Irish blood clot case after AstraZeneca jab

The first Irish case of a very rare blood clot in a person after vaccination with the Covid-19 AstraZeneca vaccine is being investigated in a 40-year-old Dublin woman.

The woman is being treated at the Mater Hospital for cerebral venous sinus thrombosis (CVST), the blood clot in the brain that EU medicines regulator, the European Medicines Agency, concluded this week was possibly linked to the AstraZeneca jab.

She is in recovery and is expected to be discharged from the Mater in the coming days after spending a week in a stroke ward in the hospital.

State medicines watchdog, the Health Products Regulatory Authority, confirmed it had received "a case of interest associated with the AstraZeneca vaccine, which describes CVST, an unusual clot in the brain." The clot was detected in a person who had received the jab.

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This is the first case of the rare blood clot following vaccination with the AstraZeneca jab to be reported to the regulator. The HPRA is carrying out further investigation.

“We are following up on this report to obtain additional details and to evaluate if it is consistent with the profile of rare blood clotting events that were the focus of the recently concluded EMA safety review,” said a spokeswoman for the HPRA.

“This report will be notified to the EU’s safety database and will be considered in the context of continuous monitoring coordinated by the EMA.”

The HPRA said it would not make any further comment on the case for confidentiality reasons. The Mater Hospital declined to comment due to patient confidentiality.

Dr Lorraine Nolan, chief executive of the HPRA, later told Thursday evening’s National Public Health Emergency Team briefing that the regulator had received “a case of special interest” involving a person with CVST and that the case would be receive the HPRA’s “utmost priority.”

She said the HPRA was “following up” on the detail of the case to get “a clearer clinical picture of what was happening with the individual in question.”

“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,” Dr Nolan told the briefing.

She stressed that the link between the blood clotting events and the AstraZeneca vaccine was “plausible but not yet fully proven.”

The sister of the Dublin woman, who asked that her identify be protected, contacted The Irish Times about her sister’s case because she was a healthy 40-year-old woman who suffered severe headaches and had to be hospitalised after receiving the AstraZeneca vaccine last month.

The patient works in the health services. Her sister said she was told by medical staff at the Mater Hospital that she is the first person in the State to suffer from this rare blood clot after vaccination with the AstraZeneca jab.

"It's just been horrendous the last week to be honest with you, so I just think it needs to be put out there that there is a case in Ireland, " the sister said.

She said her sister was “horrendously sick” with flu-like symptoms and was bed-bound for two days after receiving her first dose of the vaccine at a Dublin hospital last month.

“After the two days she didn’t feel 100 pre cent right. On Saturday, Sunday, the 28th, 29th of March she started to develop these headaches and we were all putting it down to being a bit of stress, migraine, stuff like that but it just wouldn’t go away,” she said.

“On Tuesday her face started to get puffy and swell up. She got an appointment with the doctor for Thursday morning and the doctor said I don’t like the look of you, and sent her straight to the Mater hospital, where she was admitted.

The relative said her sister was told she would be out of work for three months, that she would not be able to drive for six weeks and that she would have to live with a relative for a number of weeks or months for observation reasons.

“The severity of this is huge,” she said.

On Tuesday, the EMA concluded that there was a possible link between the AstraZeneca Covid-19 vaccine and rare blood clots in the brain in people who have received the vaccine.

Despite this finding, the EU regulatory agency still concluded that the overall benefits of this “highly effective vaccine in protecting recipients from severe Covid-19 disease, hospitalisation and death outweigh the risks of this very rare event.”

On Wednesday, the HPRA said it had been notified of 2,800 reports of suspected side effects associated with the AstraZeneca vaccine out of 204,270 doses administered.

Some 18 of these reports described “blood clots or events possibly associated with blood clots” but none were at this stage “of the nature of the very rare blood clots of concern,” including the cerebral venous sinus thrombosis, according to the regulator.

The AstraZeneca vaccine forms a key part of the Government’s Covid-19 vaccination programme, accounting for a fifth of the projected doses to be given during April, May and June.

The vaccine is currently being administered to healthcare workers and people aged between 16 and 69 with underlying health conditions who are at very high risk from Covid-19.

The UK has decided to offer people aged under 30 an alternative Covid-19 vaccine to the AstraZeneca jab following the evidence linking it to rare blood clots.

The National Immunisation Advisory Committee met on Thursday to consider the EMA's finding. It is consulting with EU colleagues and is considering whether any further advice on the use of the vaccine should be issued to the Department of Health if warranted.