title: Spontaneous reports of vasculitis as an adverse event following immunization: A descriptive analysis across three international databases.
abstract: Vasculitides have been reported as adverse events following immunization (AEFI) following various vaccines. We describe reports of vasculitis to three international spontaneous reporting systems.
  
  
  
  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®. 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.
  
  
  
  We retrieved 1797 reports of vasculitis in EV, 1171 in VAERS, and 2606 in VigiBase®. 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.
  
  
  
  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.
authors.affiliation: Italian Medicines Agency, Rome, Italy. Electronic address: contact@brightoncollaboration.org.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Felicetti
authors.affiliation: Italian Medicines Agency, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Trotta
authors.affiliation: Italian Medicines Agency, Rome, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Bonetto
authors.affiliation: Italian Medicines Agency, Rome, Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Santuccio
authors.affiliation: Brighton Collaboration Foundation, Basel, Switzerland.
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Brauchli Pernus
authors.affiliation: Monash Children's Hospital-Clayton, Melbourne, Australia; Murdoch Children's Research Institute (MCRI) - Department of Paediatrics, Melbourne University, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Burgner
authors.affiliation: Uppsala Monitoring Centre, Uppsala, Sweden.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Chandler
authors.affiliation: University of Verona, Department of Medicine, Section of Dermatology and Venereology, Verona, Italy.
authors.forename: Giampiero
authors.initials: G
authors.lastname: Girolomoni
authors.affiliation: King's College Hospital, London, UK.
authors.forename: Robert D M
authors.initials: RD
authors.lastname: Hadden
authors.affiliation: USAID, Deliver Project, JSIPL, New Delhi, India.
authors.forename: Sonali
authors.initials: S
authors.lastname: Kochhar
authors.affiliation: Department of Vaccines Control, National Agency for Medicine & Medical Devices, Tirana, Albania.
authors.forename: Merita
authors.initials: M
authors.lastname: Kucuku
authors.affiliation: Centre for Pharmacovigilance, The Lombardy Region, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Monaco
authors.affiliation: Hacettepe University, Department of Pediatric Rheumatology, Ankara, Turkey.
authors.forename: Seza
authors.initials: S
authors.lastname: Ozen
authors.affiliation: Children's Mercy Hospital, Kansas City, MO, USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Pahud
authors.affiliation: Monash Children's and Royal Children's Hospitals, Melbourne, Australia.
authors.forename: Linny
authors.initials: L
authors.lastname: Phuong
authors.affiliation: Bio Farma Vaccine Institute, Bandung, West Java, Indonesia.
authors.forename: Novilia Sjafri
authors.initials: NS
authors.lastname: Bachtiar
authors.affiliation: Centre National Anti Poison et de Pharmacovigilance, Rabat, Morocco.
authors.forename: Amina
authors.initials: A
authors.lastname: Teeba
authors.affiliation: Department of Pediatrics, Dalhousie University, Halifax, NS, Canada.
authors.forename: Karina
authors.initials: K
authors.lastname: Top
authors.affiliation: Independent Consultant Vaccinologist, Wakefield, RI, USA.
authors.forename: Frederick
authors.initials: F
authors.lastname: Varricchio
authors.affiliation: MedImmune/AstraZeneca, Gaithersburg, MD, USA.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Wise
authors.affiliation: Immunology Unit, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Zanoni
authors.affiliation: University of Pittsburgh Medical Center and Neurology service, MSL, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.
authors.forename: Saša
authors.initials: S
authors.lastname: Živkovic
authors.affiliation: University of Basel Children's Hospital, Basel, Switzerland; Brighton Collaboration Foundation, Basel, Switzerland.
authors.forename: Jan
authors.initials: J
authors.lastname: Bonhoeffer
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D005260:Female; D014943:Global Health; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D014657:Vasculitis / Q000139:chemically induced* / Q000453:epidemiology*; D055815:Young Adult
keywords: Adverse event following immunization (AEFI); Eudravigilance; Immunization; Pharmacovigilance; Spontaneous reporting; VAERS; Vaccines; Vasculitis; VigiBase(®)