Suspected side effects reported in 0.45% of vaccine shots

A total of 740 reports of suspected side effects have been notified to the medicines regulator in the first month of Ireland’s Covid-19 vaccine rollout.

The reports, the vast majority of which resolved quickly, amounted to 0.45 per cent of the 161,500 doses administered up to January 18th.

The reports received include “a small number” involving anaphylaxis, a serious allergic reaction. In all cases, the people concerned recovered, the regulator says.

Anaphylaxis is a known side-effect, whose incidence in the United States has been estimated at 11 cases per million dose of the Pfizer/BioNTech vaccine.

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The Health Products Regulatory Authority (HPRA) says that, as for all vaccines, Covid-19 vaccines should be administered under close supervision with appropriate medical treatment available in case of such a reaction.

More general allergic reactions, including itchy rash, throat tightness and/or swelling of the face or tongue, have also been reported.

The HPRA says it has also received a small number of reports of elderly patients who had underlying conditions and died following vaccination. “These reports have been carefully reviewed and based on the information provided, have not raised any concern regarding the safe use of Comirnaty [Pfizer/BioNTech vaccine] in this population.”

“It can be expected that fatalities due to progression of underlying disease or natural causes will continue to occur, including following vaccination, however, this does not mean it was caused by the vaccine.”

Second dose

The regulator says it has started to receive reports following administration of the second dose of the Pfizer/BioNTech vaccine, with a small number including comment on “the impact of otherwise mild and moderate reactions on normal daily activities”.

“These effects are not unexpected and are in line with the known safety profile with systemic events [such as fatigue, headache, muscle pain, chills, joint pain and fever] observed to occur at an increased frequency and/or intensity after the second dose, in particular in younger age groups.”

The reporting experience to date supports the favourable assessment that the benefits of Covid-19 vaccines outweigh any risks, according to the latest safety update by the HPRA.

Commonly reported suspected side effects included dizziness, headache, tingling, itchiness, rash, nausea, muscle pain, rapid heartbeat and transient increases in blood pressure, it said.

“These reports are consistent with the types of events typically observed following vaccination, including those described in the product information for this vaccine. The majority were mild to moderate in nature and had resolved/were resolving at the time of reporting.”