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.

Anterior cervical discectomy and fusion with "mini-invasive" harvesting of iliac crest graft versus polyetheretherketone (PEEK) cages: a retrospective outcome analysis.

BACKGROUND: Limited outcome data suggested a minimal evidence for better clinical and radiographic outcome of polyetheretherketone cages compared with bone grafts in the anterior cervical discectomy and fusion. We proposed a "mini-invasive" surgical technique for harvesting iliac crest grafts that provides bicortical autografts of sufficient size to be used in multilevel cervical procedures and is not associated with long-term significant donor site pain. METHODS: All patients undergoing discectomy and fusion during a three years period were consecutively extracted from computer database and retrospectively evaluated by means of telephonic interview, independently from surgical procedure (iliac crest autograph or prosthesis). Two procedure-blinded neurologists retrieved baseline clinical-demographic data and pre-surgical scores of routinely performed scales for pain and functional abilities. Afterwards, a third blinded neurologist performed clinical follow up by a semi-structured interview including Verbal Analog Scale for pain and Neck Disability Scale for discomfort. RESULTS: 80 patients out of 115 selected cases completed the follow up. 40 patients had been treated by mini-invasive bone graft harvesting and 40 with PEEK cages for cervical fusion. VAS for both neck and arm pain were significantly reduced within groups. Patients did not complaint any significant pain and/or paraesthesias at donor site from the first week after intervention. Neck Disability Scale was significantly lower at the end of follow up in both groups. CONCLUSIONS: "Miniinvasive" bicortical autografts is a less invasive, inexpensive technique to harvest iliac graft that may produce a reduced amount of general and local donor-site complications without outcome differences with prosthetic cages.

Long-term survival in cerebellar glioblastoma multiforme. Case report.

Primary cerebellar glioblastoma multiforme (GBM) is a rare tumor in adults that accounts for just 1% of all cases of GBM. Cerebellar GBMs are not yet completely understood also as far as the prognosis. We report a case of cerebellar GBM in a 27-year-old woman. Magnetic resonance imaging (MRI) showed a 3x3.6 cm-sized, ill-defined, heterogeneously enhancing mass in the left cerebellum. GBM was histologically confirmed following radical surgery. Postoperative radiotherapy with concomitant and adjuvant temozolomide chemotherapy was subsequently administrated. She has no evidence of recurrence and is in good clinical conditions up-to date, three years after surgery.

Sneddon's Syndrome presenting with topographic disorientation.

A 32-year-old woman was admitted to our department for a progressive difficulty in topographic orientation, confirmed by an extensive battery of neuropsychological tests. All biochemical and immunological examinations of blood and cerebrospinal fluid and a cerebral MRI were normal, but a technetium-99m-ethyl cysteinate dimer-single photon emission CT (Tc-99m ECD-SPECT) scan showed bilateral parietal hypoperfusion. The patient refused to undergo other examinations, but 14 months later she returned to hospital for diffuse cutaneous livedo reticularis over her trunk and legs. This time the MRI showed small frontoparietal cortical-subcortical abnormalities suggestive of arterial ischemic infarctions. We made a diagnosis of Sneddon's Syndrome (SNS). SNS is characterized by the association of livedo reticularis and cerebrovascular disease; non-dermatological onset is extremely uncommon. To our knowledge, this is the first description of a patient presenting with cognitive impairment only and observed at such an early stage of the disease that a cerebral MRI was normal.