| アブストラクト | BACKGROUND: Vasculitides have been reported as adverse events following immunization (AEFI) following various vaccines. We describe reports of vasculitis to three international spontaneous reporting systems. METHODS: All spontaneous reports of vasculitis following immunization between January 2003 and June 2014 were retrieved from Eudravigilance (EV), the Vaccine Adverse Event Reporting System (VAERS), and VigiBase((R)). A Standard MedDRA Query (SMQ) for vasculitis was used and vaccine types were categorized using the Anatomical Therapeutic Chemical classification system. We performed a descriptive analysis by source, sex, age, country, time to onset, vaccine, and type of vasculitis. RESULTS: We retrieved 1797 reports of vasculitis in EV, 1171 in VAERS, and 2606 in VigiBase((R)). Vasculitis was predominantly reported in children aged 1-17 years, and less frequently in the elderly (>65 years). The generic term "vasculitis" was the most frequently reported AEFI in this category across the three databases (range 21.9% to 27.5% of all reported vasculitis for vaccines). For the more specific terms, Henoch-Schoenlein Purpura (HSP) was most frequently reported, (19.1% on average), followed by Kawasaki disease (KD) (16.1% on average) and polymyalgia rheumatica (PMR) (9.2% on average). Less frequently reported subtypes were cutaneous vasculitis (CuV), vasculitis of the central nervous system (CNS-V), and Behcet's syndrome (BS). HSP, PMR and CuV were more frequently reported with influenza vaccines: on average in 29.3% for HSP reports, 61.5% for PMR reports and in 39.2% for CuV reports. KD was reported with pneumococcal vaccines in 32.0% of KD reports and with rotavirus vaccines in more than 20% of KD reports. BS was most frequently reported after hepatitis and HPV vaccines and CNS-V after HPV vaccines. CONCLUSION: Similar reporting patterns of vasculitides were observed in different databases. Implementation of standardized case definitions for specific vasculitides could improve overall data quality and comparability of reports. |
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| 投稿者 | Felicetti, Patrizia; Trotta, Francesco; Bonetto, Caterina; Santuccio, Carmela; Brauchli Pernus, Yolanda; Burgner, David; Chandler, Rebecca; Girolomoni, Giampiero; Hadden, Robert D M; Kochhar, Sonali; Kucuku, Merita; Monaco, Giuseppe; Ozen, Seza; Pahud, Barbara; Phuong, Linny; Bachtiar, Novilia Sjafri; Teeba, Amina; Top, Karina; Varricchio, Frederick; Wise, Robert P; Zanoni, Giovanna; Zivkovic, Sasa; Bonhoeffer, Jan |
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| 組織名 | Italian Medicines Agency, Rome, Italy. Electronic address:;contact@brightoncollaboration.org.;Italian Medicines Agency, Rome, Italy.;Brighton Collaboration Foundation, Basel, Switzerland.;Monash Children's Hospital-Clayton, Melbourne, Australia; Murdoch Children's;Research Institute (MCRI) - Department of Paediatrics, Melbourne University,;Australia.;Uppsala Monitoring Centre, Uppsala, Sweden.;University of Verona, Department of Medicine, Section of Dermatology and;Venereology, Verona, Italy.;King's College Hospital, London, UK.;USAID, Deliver Project, JSIPL, New Delhi, India.;Department of Vaccines Control, National Agency for Medicine & Medical Devices,;Tirana, Albania.;Centre for Pharmacovigilance, The Lombardy Region, Milan, Italy.;Hacettepe University, Department of Pediatric Rheumatology, Ankara, Turkey.;Children's Mercy Hospital, Kansas City, MO, USA.;Monash Children's and Royal Children's Hospitals, Melbourne, Australia.;Bio Farma Vaccine Institute, Bandung, West Java, Indonesia.;Centre National Anti Poison et de Pharmacovigilance, Rabat, Morocco.;Department of Pediatrics, Dalhousie University, Halifax, NS, Canada.;Independent Consultant Vaccinologist, Wakefield, RI, USA.;MedImmune/AstraZeneca, Gaithersburg, MD, USA.;Immunology Unit, Azienda Ospedaliera Universitaria Integrata Verona, Verona,;Italy.;University of Pittsburgh Medical Center and Neurology service, MSL, VA Pittsburgh;Healthcare System, Pittsburgh, PA, USA.;University of Basel Children's Hospital, Basel, Switzerland; Brighton;Collaboration Foundation, Basel, Switzerland. |
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