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Vaccines: 257 people have reported suspected side-effects to the health products regulator

121,900 Covid-19 vaccine doses have been administered in Ireland to date.

257 PEOPLE WHO have received a Covid-19 vaccine in Ireland reported suspected side-effects to the country’s health products regulator up until 18 January.

The figures are contained in the Health Products Regulatory Authority’s (HPRA) first regular update about reports it receives from the Irish public about suspected side-effects from the vaccines.

Earlier today, the HSE confirmed that 121,900 Covid-19 vaccine doses had been administered in Ireland as of yesterday.

The HPRA receives these reports from individuals on a voluntary basis, based on a person’s suspicion that an adverse health effect they experience may be associated with them having received a Covid-19 vaccine.

The authority emphasised that this does not mean vaccines caused the adverse effects
and says the reports it receives are referred to as “suspected” side effects as a result.

Reports may describe events which occurred in an individual after they were vaccinated, but which could have occurred even if vaccination had not taken place.

According to the HPRA, commonly reported suspected side-effects from Pfizer/BioNTech’s Covid-19 vaccine (those comprising 1% or more of all suspected cases), are consistent with the types of events typically observed following vaccination.

These include dizziness, headache, numbness, pins and needles, weakness, tiredness, feeling unwell, chills, fever, itchiness, rash, hives, nausea, diarrhoea, vomiting, joint pain, muscle pain, limb pain, injection site pain, enlarged lymph nodes, rapid heart beat and transient increases in blood pressure.

A HPRA spokeswoman confirmed to TheJournal.ie that today’s update does not include any reports of deaths in Ireland following vaccination against Covid-19.

“The majority were mild to moderate in nature and had resolved/were resolving at the time of reporting,” the authority said.

A relatively small number of reports describing signs and symptoms of allergic reactions, including itchy rash, throat tightness and swelling of the face or tongue were also reported, but all individuals have recovered since.

None of the reports received to date have been confirmed by the HPRA as anaphylaxis.

The HPRA also said it received a small number of reports describing facial paralysis or conditions associated with temporary weakness in the muscles on one side of the face following the administration of the Pfizer/BioNTech vaccine.

The authority noted that at the time these symptoms were reported to it, the onset of these symptoms was recent. It is seeking further information for each report, including to confirm if symptoms have resolved in the individuals concerned.

Meanwhile, the authority also said that given a very small number of reports of suspected side-effects relating to the Moderna vaccine, further details are not currently available.

However, it added that those reports are consistent with those typically observed with other vaccines and included in product information supplied to recipients.

Although the Pfizer/BioNTech vaccine began to be administered a number of weeks ago, the rollout of the Moderna vaccine began last weekend.

Batches of vaccines were administered to GPs across the country at vaccination centres in three locations, with just a limited number of Moderna vaccines used so far. 

At a briefing of the National Public Health Emergency Team (NPHET) on Monday, the HPRA’s Dr Lorraine Nolan said that a rigorous process was ongoing to monitor the safety of Covid-19 vaccines and that the benefits of vaccines “continue to outweigh the risks”.

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“Internationally, there have been reports of anaphylaxis associated with the use of messenger RNA vaccines,” she said.

“Anaphylaxis is a known effect that can happen with vaccination, particularly for those with a history of serious allergic reaction. It is important to stress that this is very rare. And as is the case for all vaccines, vaccination centres are well prepared for such events.

“As always, when discussing potential side effects, we must remember the risks they present is significantly outweighed by the health risk posed by the virus itself.

“However, it is vital that this information is not misconstrued, or inadvertently interpreted to become misinformation.”

The side-effects reported by the HPRA today in relation to the Pfizer/BioNTech vaccine are consistent with those seen during Phase 3 trials of the jab, when the frequency of serious adverse events was low (<0.5%).

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