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

RESULTS: We retrieved 1797 reports of vasculitis in EV, 1171 in VAERS, and 2606 in VigiBase

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(®)

Collection

Infectious Diseases

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