The State’s medicines regulator has received 24 reports of suspected side effects in children aged 17 and under who have received the Covid-19 vaccine.
Most involved symptoms such as dizziness, abdominal pain or nausea, headache, blurred vision, fainting and fever, according to the Health Products Regulatory Authority (HPRA).
“A small number of reports describe a cardiac related symptom, which oftentimes can be linked with anxiety and stress-related reactions associated with vaccination,” it said in its latest safety update.
“These reports are being followed up to better understand the type of event which occurred, with only preliminary information currently available. Overall, the reports received are consistent with the types received in adults, with most being mild to moderate in nature.”
Up to August 3rd, 13,529 reports of suspected side effects of Covid-19 vaccines had been notified to the HPRA, out of 3.14 million doses administered to that date.
The national reporting experience continues to support the favourable assessment that the benefits of the vaccines outweigh the risks, the regulator said.
Adenoviral vector vaccines (AstraZeneca and Janssen) accounted for 5,850 reports of side effects, out of 1,403,635 doses administered.
Vaccines using mRNA technology (Pfizer and Moderna) accounted for 7,589 reports, out of 4,545,069 doses administered.
The most commonly reported side effects were chills, fever, tiredness, dizziness, headache, muscle pain and nausea.
The HPRA says most of these reported side effects are consistent with the types of events typically observed following vaccination, and are mild to moderate in nature.
Just under half had resolved or were resolving at the time of reporting. For others, the suspected side effects had not yet resolved, or the outcome was unknown.
The HPRA says it has received 24 reports of cardiac-related side effects (myocarditis and pericarditis) in people who received Pfizer or Moderna vaccines. Fifteen occurred after the first dose and nine after the second, usually within 14 days of vaccination.
Suspected cases were recorded in men and women, with ages ranging from 17 to 81 – the median age was 48.
Ongoing symptoms
In some cases, possible alternative explanations other than vaccination were described, or the diagnosis was provisional. Most patients had recovered or were recovering but some had ongoing symptoms.
A further 10 reports of myocarditis and pericarditis were reported among people who received AstraZeneca and Janssen vaccines.
In 82 cases, 71 involving an mRNA vaccine, a person died after being vaccinated. Most of these occurred in patients were over 75 and involved fatalities often seen in the general population, according to the HPRA.
A total of eight reports of blood clotting combined with low platelets were notified to the HPRA among people who had received the AstraZeneca or Janssen vaccines.
Cases occurred in both men and women, with an average age of 49 – the age range was 29 to 63 years.
In a small number of cases, clotting occurred in unusual locations such as the brain or liver, the regulator said.
Six reports of a rare immune disorder of the nerves, Guillain-Barré syndrome, have also been received following vaccination with AstraZeneca or Janssen.
