Surveillance of adverse events following immunization related to human papillomavirus vaccines: 12 years of vaccinovigilance in Southern Italy.

摘要: Objectives: Human papillomavirus (HPV) vaccines have proved to be effective in preventing cervical carcinoma. Although their safety profile resembled those of any other vaccine, few clinical studies showed that HPV might also induce severe adverse events. Methods: The authors aimed investigate the vaccines, by analyzing individual case reports (ICSRs) a suspected event following immunization (AEFI) concerning were sent Italian Pharmacovigilance Spontaneous Reporting System (RNF) Campania Region from January 2007 September 2018. Results: During study period, 82 ICSRs, covering 181 AEFIs, related RNF Region. mean age patients who experienced an AEFI after vaccinations was 13 ± 4.5 years. majority ICSRs reported AEFIs considered as not serious (82%) and had favorable outcome (93%). Conclusion: overall results demonstrated that, except for cases, reflect already summary product characteristics. did identify new issues or serious, rare unexpected medically confirmed vaccines.