Ten years of vaccinovigilance in Italy: an overview of the pharmacovigilance data from 2008 to 2017.

Reporting and analysis of Adverse Events Following Immunization (AEFIs) are the cornerstones of vaccine safety surveillance prompting causality assessment and signal detection. This paper describes the impact of the Italian Pharmacovigilance System of vaccines over a 10-year period (2008-2017). The reporting rate (RR) per all distributed dose was calculated. Serious AEFIs and causality assessments for fatal cases were described. The main results from signal detection were reported. During the study period, 46,430 AEFIs were reported with an overall RR of 17.2 per 100,000 distributed doses. Italy showed the highest number of reports among European countries. Only 4.4% of the reports came from citizens. Of the total, 12.7% were classified as serious with a RR over the study period of 2.20 per 100,000 distributed doses. They were mainly related to hyperpyrexia and usually had a positive outcome. Fatal outcomes were reported in 0.3% of the cases and were primarily associated with the influenza vaccine in elderly patients. None of these outcomes had a consistent causal association with the vaccination. Febrile convulsions by the measles, mumps, rubella and varicella vaccines and intussusception by the rotavirus vaccine were among the highlighted signals. The reporting rate and the analysis of serious events from 10 years support the good risk/benefit profiles of vaccines.

[Echographic findings in a case of gastric leiomyoblastoma]. / Rilievi ecografici su un caso di leiomioblastoma gastrico.

Gastric leiomyoblastoma is a rare stomach tumour arising in the muscular tunica. Its prevalently oesophytic development makes diagnostic techniques that mainly concentrate on the intestinal lumen (digestive X-ray and endoscopy) of little use. A case is reported in which echography pointed diagnosis in the right direction by analysing a number of typical symptomatological signs.

[Hemobilia. The echographic findings in a dialyzed patient]. / Emobilia. Rilevamento ecografico in un paziente dializzato.

A case of gall bladder haematoma observed echographically in a dialysed patient is reported. The observation was probably related to the administration of anticoagulants during dialysis.

[The value of echotomographic data in mesenteric cysts]. / Il significato dei rilievi ecotomografici nelle cisti del mesentere.

The Authors report a case of chylous mesenteric cyst of great size in an adult patient. They stress the diagnostic value of roentgen and sonographic findings that are determinant for a correct preoperative diagnosis. Sonography is the most important diagnostic tool; it leads to identification and localization of the mass; moreover it gives other important information about its physic composition. The various pathology that have a similar sonographic relief are discussed and differential diagnostic characters are referred.