The Irish Health Products Regulatory Authority (HPRA) has published its second safety update on COVID-19 vaccines, after vaccinations in Ireland with the AstraZeneca COVID-19 vaccine [AZD-1222], BioNTech COVID-19 vaccine [tozinameran; Comirnaty] and Moderna COVID-19 vaccine [mRNA-1273], concluding that national data continue to support a favourable benefit-risk profile for these vaccines.
In total, 147 700 first doses and 13 800 second doses of COVID-19 vaccines were administered in Ireland as of 27 January 2021. The HPRA had received 740 reports of suspected adverse events (AEs) as of 28 January, and the most frequently reported AEs were in line with those generally associated with vaccination and were described in COVID-19 product information.
The most frequently reported suspected AEs (≥1% of total AEs) in Ireland were: dizziness and headache; numbness and paraesthesia; weakness, tiredness, chills and fever; exanthema, pruritus and urticaria; nausea, diarrhoea and vomiting; muscle pain, musculoskeletal pain and limb pain; injection site pain and injection site redness; and lymphadenopathy. Systemic AEs were reported at an increased frequency or intensity after the second dose of tozinameran, particularly in younger patients.
Reports of signs and symptoms of allergic reactions included itchy rash, throat tightness and swelling of the face or tongue, and a small number of these were classified by the HPRA as anaphylaxis. The HPRA is continuing to monitor a small number of reports of facial paralysis and Bell's palsy. It has reviewed a small number of reports of deaths after vaccination with tozinameran in elderly patients with underlying conditions, and says that these reports have not raised any concerns regarding the safety of the vaccine in this population.
HPRA. Safety Update: COVID-19 Vaccines - Overview of National Reporting Experience - 4 February 2021. Internet Document : 4 Feb 2021. Available from: URL: https://www.hpra.ie/homepage/medicines/safety-notices/item?t=/safety-update-covid-19-vaccines-overview-of-national-reporting-experience-4-february-2021&id=cbec0e26-9782-6eee-9b55-ff00008c97d0
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Second HPRA safety update on COVID-19 vaccines. Reactions Weekly 1843, 4 (2021). https://doi.org/10.1007/s40278-021-91106-7