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

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.

• Authors: Patrizia Felicetti, Francesco Trotta, Caterina Bonetto, Carmela Santuccio, Yolanda Brauchli Pernus, David Burgner, Rebecca Chandler, Giampiero Girolomoni, Robert D M Hadden, Sonali Kochhar, Merita Kucuku, Giuseppe Monaco, Seza Ozen, Barbara Pahud, Linny Phuong, Novilia Sjafri Bachtiar, Amina Teeba, Karina Top, Frederick Varricchio, Robert P Wise, Giovanna Zanoni, Saša Živkovic, Jan Bonhoeffer, Brighton Collaboration Vasculitis Working Group
• Journal: Vaccine (Vaccine) Vol. 34 Issue 51 Pg. 6634-6640 (12 12 2016) ISSN: 1873-2518 [Electronic] Netherlands
• PMID: 26392009 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Published by Elsevier Ltd.

Topics

• Adolescent
• Adult
• Adverse Drug Reaction Reporting Systems
• Aged
• Aged, 80 and over
• Child
• Child, Preschool
• Databases, Factual
• Female
• Global Health
• Humans
• Immunization (adverse effects)
• Infant
• Infant, Newborn
• Male
• Middle Aged
• Prevalence
• Vasculitis (chemically induced, epidemiology)
• Young Adult