In the context of the H1N1 pandemic and the Pandemrix vaccination campaign, an increased number of narcolepsy cases were noted in several countries. In Sweden, this phenomenon was attributed to the effect of the Pandemrix vaccination in the first place. Interestingly, Denmark, a neighboring country, also had an increased incidence during this period, despite a low vaccination rate. Additionally, studies from China indicated that narcolepsy could occur as a consequence of the H1N1 infection itself. Against these background factors, and due to the clinical impression that narcolepsy patients who were vaccinated tend to dominate in the Swedish narcolepsy polyclinic, we performed an analysis of the increase with a specific interest in age and sex distribution. We also aimed to validate the origin of the excess cases, post hoc. Materials & Methods: The data for narcolepsy patients (ICD code G 47.4) distributed by sex and age at 5-year intervals, annually between 2005 and 2017, was retrieved from the National Patient Register. Information on the total population was collected from the Swedish Population Register and was used for calculations of the narcolepsy prevalence. Results: The number of narcolepsy cases increased markedly from 2009 to 2014 compared to the period before 2009. A particular increase in 2011 among children and teenagers was observed, which resulted in increased cases among the age group 20-39 years in the following years. The sex ratio did not change significantly during the study period. The excess cases found in our study exceeded the number of patients who so far (December 2023) received economic compensation for vaccine side effects (n=450). Conclusions: Our results confirm an association between the increased prevalence of narcolepsy cases and the Pandemrix vaccination. Consequently, the effect of the virus itself cannot be ruled out as a contributing factor. The delayed timing in diagnostics is crucial when determining the number of cases with onset during the pandemic.

The aim of this study was to develop, implement, and evaluate a new auxiliary enterprise risk management framework and process to serve as an enabler to the global ISO 31000 risk framework and ISO 31010 processes. This framework has been designed particularly for use within high-risk environments and those characterized by volatility, uncertainty, complexity, and ambiguity (VUCA). This paper proposes a methodology for optimization of structured sharing and grass-roots management of all available risk-sentience information with the assessed potential to develop into an identifiable risk in the future. The author introduces new risk terminology including risk-sentience, risk-sentience information, and risk-sentience management. The process involved the development of the Theory of Risk-Sentience (ToRS), Risk-Sentience Auxiliary Framework (RSAF) and a risk-sentience management process referred to as LUOMEAR (Learning from Uncertainties, Others Mistakes, Experiences and Anecdotal Reporting). Manchester Patient Safety Framework (MaPSaF), SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis, and a newly developed Risk-Sentience Fertility Checklist were used to conduct pre and post-trial evaluations. The findings include positive adjustments in safety culture, components of commitment to quality, communication and team-working around safety issues, access to evolving risk-information, and efficient sharing and management of recorded risk-information. Recommendations are made for more extensive application of both the proposed auxiliary risk framework and process within high-risk sectors to further explore its effectiveness and scope.