Nearly 15,000 reports of suspected Covid vaccine side effects made to HPRA

Causal link between reported effects and vaccine not necessarily proven – regulator

The majority of reports of suspected side effects of the coronavirus vaccines were mild to moderate, according to the HPRA. Photograph: iStock

The majority of reports of suspected side effects of the coronavirus vaccines were mild to moderate, according to the HPRA. Photograph: iStock

 

The State’s medicines regulator has received nearly 15,000 reports of suspected side effects of Covid-19 vaccines administered in the State.

Most common were flu-like symptoms such as fever, chills, dizziness, joint pain and nausea, the Health Products Regulatory Authority (HPRA) said in its latest safety report, published as an “enhanced transparency measure” for members of the public and healthcare professionals.

All vaccines have side effects, the report notes, and the majority of reports of suspected side effects of the coronavirus vaccines were mild to moderate.

Up to August 31st, more than 6.84 million doses of the coronavirus vaccine had been administered, with the HPRA receiving 14,844 reports of suspected side effects in the same period. Of these, 8,686 related to Pfizer or Moderna mRNA technology vaccines, while adenoviral vector vaccines (AstraZeneca and Janssen) accounted for 6,059 reports.

The HPRA says it received 78 reports of suspected side effects among adolescents aged 12-17 years who had received an mRNA vaccine. The agency is “closely monitoring” any reports related to teenagers and overall the symptoms are consistent with those reported in adults.

Between 1 per cent and 10 per cent of reports to the HPRA mention symptoms such as chest pain, increased heart rate, blurred vision, shortness of breath and disturbances to a woman’s menstrual cycle.

Crucial to interpreting the data, the report says, is understanding that alerts to the authority are based on a suspicion that there may be a link to the vaccine. Causation has not necessarily been determined and some could be “coincidental events”, it says.

There have been 86 instances (75 involving an mRNA vaccine) where an individual who had been vaccinated subsequently passed away. Most of these are related to people aged over 75 and involved fatalities often seen in the general population, such as an underlying illness, according to the HPRA.

There have been 60 reports relating to inflammatory conditions of the heart in people who had received an mRNA vaccine. Of these, 18 were suspected myocarditis, 26 suspected pericarditis and 16 were a combination of the two. Cases occurred in both men and women, with a median age of 39 and an age range of 12-81. In some cases there were possible alternative explanations, or the diagnosis was provisional.

The AstraZeneca or Janssen vaccines were referenced in 13 reports of inflammatory heart conditions. At this point no causal relationship has been established between such symptoms and the adenoviral vector vaccines, according to the HPRA.

Nine reports of blood clotting combined with low platelets were reported among people who had received the AstraZeneca or Janssen vaccines. There were also 11 cases of a condition where the immune system mistakenly reacts to platelets, none of which occurred following the Janssen vaccine.

Nine reports of a rare immune disorder of the nerves, Guillain-Barré syndrome, have also been received following vaccination with AstraZeneca or Janssen.