Spontaneous reports of vasculitis as an adverse event following immunization: A descriptive analysis across three international databases

Patrizia Felicetti, Francesco Trotta, Caterina Bonetto, Carmela Santuccio, Yolanda Brauchli Pernus, David Burgner, Rebecca Chandler, Giampiero Girolomoni, Robert D.M. Hadden, Sonali Kochar, Merita Kucuku, Giuseppe Monaco, Seza Ozen, Barbara Pahud, Linny Kimly Phuong, Novilia Sjafri Bachtiar, Amina Teeba, Karina A. Top, Frederick Varricchio, Robert P. WiseGiovanna Zanoni, Saša Živkovic, Jan Bonhoeffer, for the Brighton Collaboration Vasculitis Working Group

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12 Citations (Scopus)

Abstract

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®. 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®. 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.

Original languageEnglish
Pages (from-to)6634-6640
Number of pages7
JournalVaccine
Volume34
Issue number51
DOIs
Publication statusPublished - 12 Dec 2016
Externally publishedYes

Keywords

  • Adverse event following immunization (AEFI)
  • Eudravigilance
  • Immunization
  • Pharmacovigilance
  • Spontaneous reporting
  • Vaccines
  • VAERS
  • Vasculitis
  • VigiBase

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