Spontaneous reports of vasculitis as an adverse event following immunization: A descriptive analysis across three international databases.
PMID: 26392009 DOI: 10.1016/j.vaccine.2015.09.027
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.
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
Adverse event following immunization (AEFI); Eudravigilance; Immunization; Pharmacovigilance; Spontaneous reporting; VAERS; Vaccines; Vasculitis; VigiBase(®)
Felicetti, Patrizia; Trotta, Francesco; Bonetto, Caterina; Santuccio, Carmela; Brauchli Pernus, Yolanda; Burgner, David; Chandler, Rebecca; Girolomoni, Giampiero; Hadden, Robert D M; Kochhar, Sonali; Kucuku, Merita; Monaco, Giuseppe; Ozen, Seza; Pahud, Barbara A.; Phuong, Linny; Bachtiar, Novilia Sjafri; Teeba, Amina; Top, Karina; Varricchio, Frederick; Wise, Robert P.; Zanoni, Giovanna; Živkovic, Saša; Bonhoeffer, Jan; and Brighton Collaboration Vasculitis Working Group, "Spontaneous reports of vasculitis as an adverse event following immunization: A descriptive analysis across three international databases." (2016). Manuscripts, Articles, Book Chapters and Other Papers. 530.