Vasculitis as an adverse event following immunization - Systematic literature review.

Background: Several types of vasculitis have been observed and reported in temporal association withthe administration of various vaccines. A systematic review of current evidence is lacking.Objective: This systematic literature review aimed to assess available evidence and current reportingpractice of vasculitides as adverse events following immunization (AEFI).Methods: We reviewed the literature from 1st January 1994 to 30th June 2014. This review comprisesrandomized controlled trials, observational studies, case series, case reports, reviews and commentsregardless of vaccine and target population.Results: The initial search resulted in the identification of 6656 articles. Of these, 157 articles were assessedfor eligibility and 75 studies were considered for analysis, including 6 retrospective/observational stud-ies, 2 randomized controlled trials, 7 reviews, 11 case series, 46 case reports and 3 comments. Mostof the larger, higher quality studies found no causal association between vaccination and subsequentdevelopment of vasculitis, including several studies on Kawasaki disease and Henoch-Sch\uf6nlein purpura(IgA vasculitis). Smaller case series reported a few cases of vasculitis following BCG and vaccines againstinfluenza and hepatitis. Only 24% of the articles reported using a case definition of vasculitis

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

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\uae. 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\uae. 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