Title

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

Document Type

Article

Publication Date

12-12-2016

Identifier

PMID: 26392009 DOI: 10.1016/j.vaccine.2015.09.027

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.

Journal Title

Vaccine

Volume

34

Issue

51

First Page

6634

Last Page

6640

MeSH Keywords

Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Aged; Aged, 80 and over; Child; Child, Preschool; Databases, Factual; Female; Global Health; Humans; Immunization; Infant; Infant, Newborn; Male; Middle Aged; Prevalence; Vasculitis; Young Adult

Keywords

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

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