This criterion often leads to misunderstandings. Another criterion for classifying a case as serious is whether it is described as "medically important" or resulting in "temporary severe impairment". If the administration of a drug to a pregnant woman has led to an adverse reaction or damage in the newborn child, this situation should always be classified as serious. Cases are also considered to be serious if they have resulted in disability or permanent damage that caused substantial disruption to a person's ability to conduct normal life functions. It is always classified as serious if the suspected adverse reaction was life-threatening, resulted in hospitalisation or prolonged an existing hospitalisation, or in cases involving a fatal outcome. Internationally binding criteria exist for classifying a suspected adverse reaction to a drug or vaccine as "serious". Swissmedic is also consulting partner authorities in other countries on the issue and will provide information as soon as new and relevant findings are available. Swissmedic appeals to medical professionals reporting suspected cases of post-vaccine syndrome to provide details of the patient’s previous medical history and the diagnostic procedures followed so that it has a larger amount of medical information to evaluate. Given this lack of clarity, it is also not possible to provide reliable information on the number of reports received that involve the syndrome. For example, it is unclear which symptoms can be ascribed to post-vaccine syndrome, how long these symptoms have to persist before patients can be suspected to have the syndrome, and how it can be distinguished from long COVID in the light of the high rate of past SARS-CoV-2 infections. At present, there is no recognised standard definition of post-vaccine syndrome. Swissmedic treats reports of such cases very seriously and continually reviews the latest drug safety findings and medical science literature. The symptoms reported, which may result in significant impairment for some of the individuals affected, cover a broad spectrum and overlap in some cases with long COVID and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). In the context of COVID-19 vaccinations, certain highly heterogeneous and generally prolonged symptoms that have occurred in vaccinated individuals with a temporal relationship to vaccination are also referred to as “post-vaccine syndrome”. Information from Swissmedic on individual safety aspects Post-vaccine syndrome However, the Agency will continue to monitor COVID-19 vaccines closely and new information on risks and safety signals will be communicated via the usual channels (website, DHPCs). The vaccines authorised in Switzerland reliably reduce the risk of contracting severe COVID-19.įor some time now, Swissmedic has been receiving far fewer reports of suspected adverse reactions than when vaccination first started and will therefore provisionally cease publishing regular updates on reported adverse reactions to COVID-19 vaccines in their current form.
Thanks to the widespread use of COVID-19 vaccines, it is possible to continually gather up-to-date and comprehensive data on the risk-benefit ratio and include information on as-yet unknown rare side effects in the medicinal product information. The reports of suspected adverse drug reactions (ADR) to COVID-19 vaccinations are evaluated in collaboration with the regional pharmacovigilance centres and in particular with the Ticino reference centre (EOC cantonal hospital authority).Īccording to the World Health Organization (WHO), over 13 billion doses of coronavirus (SARS-CoV-2) vaccine had been administered worldwide as at 14 February 2023.
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