In this article we summarize suspected adverse events following immunization (AEFI) of pericarditis, myocarditis and perimyocarditis that were reported by our regional pharmacovigilance centre after COVID-19 mRNA-vaccination and discuss their association with these vaccines. Seventeen cases were reported between March and July 2021. Of these, nine had perimyocarditis, five myocarditis and three pericarditis. Twelve patients were male (71 %). The median age was 38 years (range 17 - 88). The most commonly observed presenting symptom was acute chest pain (65%). While 47% of the patients were previously healthy, 53% had at least one pre-existing comorbidity, with hypertension being the most prevalent (24%). The European Society of Cardiology diagnostic criteria for the reported AEFIs were fulfilled in twelve cases (71%). The AEFIs occurred after the first vaccine dose in six cases (35%), after the second vaccine dose in ten cases (59%) and after both doses in one case (6%). The median latency of all AEFIs taken together was 14 days (range 1 - 28) after the first vaccination and 3 days (range 1 - 17) after the second one. All patients except one were hospitalized (94%) with a median length of stay of 7.5 days (range 3 - 13). The majority of patients (n = 11, 65%) did not experience any complications, and 13 (77%) of the patients were recovered or recovering at the time of discharge. In 16 of the 17 cases (94%), the association between the AEFI and mRNA-vaccination was considered possible by the pharmacovigilance centre.
Telaprevir (TPV) is one of the NS3/4A serine protease inhibitors on the market for the treatment of chronic hepatitis C genotype 1 in combination with peginterferon alpha and ribavirin. Well-documented potential adverse reactions of TPV are hematological, skin, and gastro-intestinal disorders. Until now, there were no conclusive data from clinical trials about renal adverse reactions of TPV. We report here three cases of renal impairment that occurred after a few days of TPV treatment and resolved in about 2 weeks after stopping the drug. Two of the patients were hospitalized because of this serious adverse drug reaction. Therefore, renal impairment seems to be a new adverse drug reaction of TPV and clinicians should be aware of this potentially serious complication of chronic hepatitis C therapy.
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