Covid-19 Vaccines: Is the Seriousness Criterion "Medically Important" Applied Correctly in Reports and Are There Differences between HCPs and Non-HCPs?: An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Introduction: During the Covid-19 vaccination campaign, Swissmedic received approximately 50% of the spontaneous reports from health care professionals (HCP) and 50% directly from patients/consumers. The rate of adverse drug reactions (ADRs) following Covid-19 vaccination categorized as "serious" by the reporters is approximately 35% in Switzerland and thus significantly higher than e.g. in the US (6.6%), while rates of reports with fatal outcome are comparable (1.4% vs. 1.3%) (1). A high proportion of the cases labelled as "serious" in Switzerland was classified based on the category "medically important". Since this criterion is used very commonly but is less distinct than the other seriousness criteria, we aimed to analyze whether it is used correctly by the reporters and whether differences between healthcare professionals and patients/consumer can be identified. Objective: To evaluate the appropriate usage of the seriousness criterion "medically important" in spontaneous ADR reports submitted by health care professionals compared to non-health care professionals following immunization with a Covid-19 vaccine. Methods: All serious ADR reports received between the 1st of January 2021 and 31st of December 2021 following immunization with a Covid-19 vaccine were extracted from the Swiss database. Cases categorized as "medically important" were further analyzed. We extracted the preferred terms (PT) according to the medical dictionary for regulatory activities (MedDRA) (2) of the reported ADRs and matched them with the important medical event terms list (IME list) (3). Results: From a total of 11,115 ADR reports, 4,125 (37.1%) were classified as "serious". 2,773 (67.2%) of the serious cases were reported by HCPs and 1,352 (32.8%) by non-HCPs. In 2,260 (55%) reports, the seriousness was based solely on the criterion "medically important". 755 (33.4%) of these reports would also be classified as "serious" according to the IME List. 498 (39%) reports by HCP and 257 (26%) by non-HCP match with the IME list. The proportion of correctly categorized ADRs is significantly higher (p < 0.0001) in reports from HCPs compared to non-HCPs. Conclusion: Only approximately one third of the cases, which were classified as "medically important" and thus reported as "serious", would also be classified as such according to the IME list. The proportion of correctly categorized ADRs is significantly higher in reports from HCPs. Additional information and training for HCPs appears necessary to achieve a higher rate of appropriate seriousness categorization in ADR reports. The usage of the category "medically important" in reports by patients/consumers requires general revision.