Heart inflammation after receiving a Covid-19 vaccine was the subject of 83 reports, according to the latest update from the Health Protection Regulatory Authority.
This is an increase of three from the last safety update over a month ago.
However, no significant new issues have emerged in the latest report on the safety of Covid-19 vaccines from the State’s drugs regulator.
The authority says there have been no reports in Ireland of multisystem inflammatory syndrome (MIS) after administration of Covid-19 vaccines.
MIS, a rare but serious condition affecting many parts of the body, has been the subject a handful of reports across Europe. A review by the European Medicines Agency recently found there was not enough evidence to support a link between these cases and Covid-19 vaccination.
The reports to the HPRA of health inflammation include 28 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.
Men were over-represented among the cases - 57 reports against 26 for women.
The median age of the people whose cases were the subject of reports was 35 and cases ranged in age from 12 to 81 years. Five cases involved adolescents aged between 12 and 17.
“In the majority of the cases, the individuals were still recovering or had ongoing symptoms at the time of initial reporting,” the HPRA said.
The EMA last month told Pfizer and Moderna to review their data on the frequency of these conditions following Covid-19 vaccination. Its safety committee plans to assess this data before deciding whether product information needs to be updated.
A total of 15,705 reports of suspected side-effects had been notified up to the end of October, an increase of 281 over the past month. By October 26th, 7,317,176 doses of the four authorised vaccines had been administered.
Some 9,463 of the reports related to mRNA vaccines (Pfizer or Moderna), and the remaining 6,140 reports related to adenoviral vector vaccines (AstraZeneca and Janssen).
Side effects
Some 195 reports of suspected side effects following vaccination of an adolescent with an mRNA vaccine were received, up from 168 a month earlier.
Ninety reports concerned a person who died after vaccination, the same number as in the last report. Eighty per cent involved patients aged over 75.
“For a number of reports, the cause of death was unconfirmed at the time of reporting, with post mortem results awaited.”
“Reports describing a death are carefully reviewed,”. The report states. “However, it can be expected that fatalities due to progression of underlying disease or natural causes will continue to occur, including following vaccination. This does not mean that the vaccine caused the deaths.”
No new reports of anaphylaxis, a severe allergic reaction, were made since the last report.
There were 10 reports of serious blood clotting combined with low platelet count after AstraZeneca or Janssen vaccines, up one from October.
In some cases, clotting occurred in the brain or liver. The patients involved were either discharged or are still recovering in hospital.
Meanwhile, 136 breakthrough infections have been reported among vaccinated Covid-19 patients admitted to ICU since April, according to a separate update.
This is 27 per cent of the total of 507 Covid-19 patients admitted to ICU over the period, according to figures from the Health Protection Surveillance Centre.
Of the breakthrough infections, 88 were male and 48 female. The average age was 65 and one in three died. All but three of the 136 cases had an underlying condition.
There were 253 breakthrough infections among vaccinated Covid-19 patients who died during the period, the HPSC also reports.
This is 47 per cent of the 535 Covid-19 deaths over the period.
Of the breakthrough infections, 138 were male and 115 female. The average age was 80 and 72 per cent had an underlying condition.
Currently, almost 92 per cent of over-12s in the population are fully vaccinated.
