Regulator receives 80 reports of heart inflammation after Covid-19 vaccines

Eighty people have reported experiencing heart inflammation after receiving a Covid-19 vaccine, according to a report from the State’s drugs regulator.

The Health Protection Regulatory Authority has received 25 side-effects reports of myocarditis (inflammation of the heart muscle), 33 reports of pericarditis (inflammation of the heart lining) and 22 involving a combination of both.

Seventy occurred after vaccination with the Pfizer vaccine and 10 after vaccination with Moderna. Men were over-represented among the cases accounting for 57 reports against 23 for women. The median age of reports was 35 years and cases ranged in age from 12 to 81 years, with five involving people aged 12 to 17.

The authority says in a number of cases possible alternative explanations other than vaccination were described. In a majority of the cases the individuals were still recovering or had ongoing symptoms at the time of reporting.

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A total of 15,424 reports of suspected side-effects had been notified up to the end of September, with some 7.2 million doses of the four authorised vaccines having been administered by then.

Some 9,207 of the reports related to mRNA vaccines (Pfizer or Moderna), a rate of one per 628 doses. The remaining 6,123 reports related to adenoviral vector vaccines (AstraZeneca and Janssen), a rate of one per 233 doses.

A total of 168 reports of suspected side effects following vaccination of an adolescent with an mRNA vaccine were received.

Ninety reports concerned a person who died after vaccination. The majority of these events were reported in patients aged over 75 and include fatalities often seen in the general population, such as those due to natural causes or progression of an underlying disease. In a number of cases the cause of death was unconfirmed at the time of reporting, with postmortem results being awaited.

Twelve reports concerned anaphylaxis, a severe allergic reaction, following an mRNA vaccine. There was a small number of reports of same after adenoviral vector vaccines.

In up to 10 per cent of reports, people said they needed to take time off work or rest in bed, usually for a short period, due to “systemic events” such as developing flu-like symptoms, fatigue and headaches in the days following vaccination.

The authority said menstrual disturbances - such as early, late or heavy periods - are one of the more regularly reported side-effects. The European Medicines Agency is reviewing the reports but has yet to find a causal association with vaccination.

The safety report also lists five reports of immune thrombocytopenia (ITP) in people following vaccination with AstraZeneca, and 12 cases of blood clotting following the Janssen vaccine. There were also nine reports of serious blood clotting combined with low platelet count after AstraZeneca or Janssen vaccines. In some cases, clotting occurred in the brain or liver. The patients involved have either been discharged or are still recovering in hospital.