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Vaccine. 2016 Dec 12;34(51):6634-6640. doi: 10.1016/j.vaccine.2015.09.027. Epub 2015 Sep 21.

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

Author information

1
Italian Medicines Agency, Rome, Italy. Electronic address: contact@brightoncollaboration.org.
2
Italian Medicines Agency, Rome, Italy.
3
Brighton Collaboration Foundation, Basel, Switzerland.
4
Monash Children's Hospital-Clayton, Melbourne, Australia; Murdoch Children's Research Institute (MCRI) - Department of Paediatrics, Melbourne University, Australia.
5
Uppsala Monitoring Centre, Uppsala, Sweden.
6
University of Verona, Department of Medicine, Section of Dermatology and Venereology, Verona, Italy.
7
King's College Hospital, London, UK.
8
USAID, Deliver Project, JSIPL, New Delhi, India.
9
Department of Vaccines Control, National Agency for Medicine & Medical Devices, Tirana, Albania.
10
Centre for Pharmacovigilance, The Lombardy Region, Milan, Italy.
11
Hacettepe University, Department of Pediatric Rheumatology, Ankara, Turkey.
12
Children's Mercy Hospital, Kansas City, MO, USA.
13
Monash Children's and Royal Children's Hospitals, Melbourne, Australia.
14
Bio Farma Vaccine Institute, Bandung, West Java, Indonesia.
15
Centre National Anti Poison et de Pharmacovigilance, Rabat, Morocco.
16
Department of Pediatrics, Dalhousie University, Halifax, NS, Canada.
17
Independent Consultant Vaccinologist, Wakefield, RI, USA.
18
MedImmune/AstraZeneca, Gaithersburg, MD, USA.
19
Immunology Unit, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy.
20
University of Pittsburgh Medical Center and Neurology service, MSL, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.
21
University of Basel Children's Hospital, Basel, Switzerland; Brighton Collaboration Foundation, Basel, Switzerland.

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.

KEYWORDS:

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

PMID:
26392009
DOI:
10.1016/j.vaccine.2015.09.027
[Indexed for MEDLINE]

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