Reports of suspected adverse reactions to the COVID-19 vaccines in Switzerland – Update

To date, 63 side effect reports in connection with COVID-19 vaccinations in Switzerland have been evaluated

05.02.2021

As at 4 February 2021, Swissmedic, in collaboration with the regional pharmacovigilance centres, has evaluated 63 reports of suspected adverse drug reactions (ADR) to COVID-19 vaccinations in Switzerland. So far there is no evidence of new safety signals.

As at 4 February 2021, a total of 63 reports of suspected adverse drug reactions (ADR) in connection with the COVID-19 vaccinations in Switzerland have been evaluated and assessed at Swissmedic.

Of those patients affected, there were more women (57%) than men (32%), although the gender is not stated in some reports (11%).

37 reports (59%) were classified as not serious. The most commonly reported reactions in these non-serious reports were headache, chills, fever and pain at the injection site.

26 reports (41%) were classified as serious. The most common were breathing difficulties (dyspnoea), skin swelling (angioedema), skin rashes associated with allergic reactions and severe flu symptoms, including high fever or badly aching limbs. In six of the serious reports, fatalities were reported in patients aged between 85 and 92 with pre-existing illnesses. As far as is currently known, these deaths resulted from illnesses that commonly occur in this age range, including infections, cardiovascular events or diseases of the lungs and respiratory tract. Despite a chronological correlation, there is no concrete evidence to suggest that the vaccination was the cause of death.

The reports of adverse reactions received to date and subjected to careful analysis do not change the positive benefit-risk profile of the COVID-19 vaccines. Known side effects of COVID-19 vaccines are listed in the product information texts published at www.swissmedicinfo.ch.

Numerous other reports of suspected adverse reactions to COVID-19 vaccines have been received by Swissmedic, particularly in recent days. The information presented here will be updated as soon as new results on evaluated cases are available.

Internationally as well, fatalities in elderly people with pre-existing illnesses who have also received a COVID-19 vaccination are being carefully analysed. For this purpose, Swissmedic remains in regular contact with the drug regulatory authorities in other countries. To date, these investigations have also not shown any evidence of a causal connection.

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