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Title: | Spontaneous reports of vasculitis as an adverse event following immunization: A descriptive analysis across three international databases. | Authors: | Felicetti P.;Chandler R.;Girolomoni G.;Hadden R.D.M.;Kochar S.;Kucuku M.;Monaco G.;Ozen S.;Pahud B.;Phuong L.;Bachtiar N.S.;Teeba A.;Top K.;Varricchio F.;Wise R.P.;Zanoni G.;Zivkovic S.;Bonhoeffer J.;Burgner D.;Brauchli Pernus Y.;Santuccio C.;Bonetto C.;Trotta F. | Institution: | (Felicetti, Trotta, Bonetto, Santuccio) Italian Medicines Agency, Rome, Italy (Brauchli Pernus, Bonhoeffer) Brighton Collaboration Foundation, Basel, Switzerland (Burgner) Monash Children's Hospital-Clayton, Melbourne, Australia (Burgner) Murdoch Children's Research Institute (MCRI) - Department of Paediatrics, Melbourne University, Australia (Chandler) Uppsala Monitoring Centre, Uppsala, Sweden (Girolomoni) University of Verona, Department of Medicine, Section of Dermatology and Venereology, Verona, Italy (Hadden) King's College Hospital, London, United Kingdom (Kochar) USAID, Deliver Project, JSIPL, New Delhi, India (Kucuku) Department of Vaccines Control, National Agency for Medicine & Medical Devices, Tirana, Albania (Monaco) Centre for Pharmacovigilance, The Lombardy Region, Milan, Italy (Ozen) Hacettepe University, Department of Pediatric Rheumatology, Ankara, Turkey (Pahud) Children's Mercy Hospital, Kansas City, MO, United States (Phuong) Monash Children's and Royal Children's Hospitals, Melbourne, Australia (Bachtiar) Bio Farma Vaccine Institute, Bandung, West Java, Indonesia (Teeba) Centre National Anti Poison et de Pharmacovigilance, Rabat, Morocco (Top) Department of Pediatrics, Dalhousie University, Halifax, NS, Canada (Varricchio) Independent Consultant Vaccinologist, Wakefield, RI, United States (Wise) MedImmune/AstraZeneca, Gaithersburg, MD, United States (Zanoni) Immunology Unit, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy (Zivkovic) University of Pittsburgh Medical Center and Neurology service, MSL, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States (Bonhoeffer) University of Basel Children's Hospital, Basel, Switzerland | Issue Date: | 14-Dec-2016 | Copyright year: | 2016 | Publisher: | Elsevier Ltd | Place of publication: | United Kingdom | Publication information: | Vaccine. 34 (51) (pp 6634-6640), 2016. Date of Publication: 12 Dec 2016. | Journal: | Vaccine | 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.Copyright © 2015 | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1016/j.vaccine.2015.09.027 | PubMed URL: | 26392009 [http://www.ncbi.nlm.nih.gov/pubmed/?term=26392009] | ISSN: | 0264-410X | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/39750 | Type: | Article | Subjects: | middle aged mucocutaneous lymph node syndrome/si [Side Effect] newborn papillomavirus infection/dt [Drug Therapy] papillomavirus infection/pc [Prevention] pneumococcal infection/dt [Drug Therapy] pneumococcal infection/pc [Prevention] polyarteritis nodosa/si [Side Effect] preschool child priority journal purpura/si [Side Effect] rheumatic polymyalgia/si [Side Effect] Rotavirus infection/dt [Drug Therapy] Rotavirus infection/pc [Prevention] school child skin disease/si [Side Effect] skin tuberculosis/si [Side Effect] temporal arteritis/si [Side Effect] tetanus/dt [Drug Therapy] tetanus/pc [Prevention] *vaccination vasculitic rash/si [Side Effect] *vasculitis/si [Side Effect] vasculitis/si [Side Effect] virus infection/dt [Drug Therapy] virus infection/pc [Prevention] yellow fever/dt [Drug Therapy] yellow fever/pc [Prevention] young adult bacterial vaccine/ae [Adverse Drug Reaction] bacterial vaccine/dt [Drug Therapy] encephalitis vaccine/ae [Adverse Drug Reaction] encephalitis vaccine/dt [Drug Therapy] Haemophilus influenzae vaccine/ae [Adverse Drug Reaction] Haemophilus influenzae vaccine/dt [Drug Therapy] hepatitis vaccine/ae [Adverse Drug Reaction] hepatitis vaccine/dt [Drug Therapy] influenza vaccine/ae [Adverse Drug Reaction] influenza vaccine/dt [Drug Therapy] measles vaccine/ae [Adverse Drug Reaction] measles vaccine/dt [Drug Therapy] Meningococcus vaccine/ae [Adverse Drug Reaction] Meningococcus vaccine/dt [Drug Therapy] Pneumococcus vaccine/ae [Adverse Drug Reaction] Pneumococcus vaccine/dt [Drug Therapy] Rotavirus vaccine/ae [Adverse Drug Reaction] Rotavirus vaccine/dt [Drug Therapy] tetanus toxoid/ae [Adverse Drug Reaction] tetanus toxoid/dt [Drug Therapy] *vaccine/ae [Adverse Drug Reaction] varicella zoster vaccine/ae [Adverse Drug Reaction] virus vaccine/ae [Adverse Drug Reaction] virus vaccine/dt [Drug Therapy] Wart virus vaccine/ae [Adverse Drug Reaction] Wart virus vaccine/dt [Drug Therapy] yellow fever vaccine/ae [Adverse Drug Reaction] yellow fever vaccine/dt [Drug Therapy] varicella zoster vaccine/dt [Drug Therapy] Behcet disease/si [Side Effect] brain vasculitis/si [Side Effect] central nervous system disease/si [Side Effect] child Churg Strauss syndrome/si [Side Effect] controlled study encephalitis/dt [Drug Therapy] encephalitis/pc [Prevention] female granulomatosis/si [Side Effect] Haemophilus infection/dt [Drug Therapy] Haemophilus infection/pc [Prevention] hepatitis/dt [Drug Therapy] hepatitis/pc [Prevention] adolescent adult aged anaphylactoid purpura/si [Side Effect] arteritis/si [Side Effect] article bacterial infection/dt [Drug Therapy] bacterial infection/pc [Prevention] herpes zoster/dt [Drug Therapy] herpes zoster/pc [Prevention] human hypersensitivity/si [Side Effect] infant influenza/dt [Drug Therapy] influenza/pc [Prevention] major clinical study male measles/dt [Drug Therapy] measles/pc [Prevention] meningococcosis/dt [Drug Therapy] meningococcosis/pc [Prevention] child Churg Strauss syndrome / side effect controlled study encephalitis / drug therapy / prevention female granulomatosis / side effect Haemophilus infection / drug therapy / prevention hepatitis / drug therapy / prevention herpes zoster / drug therapy / prevention human hypersensitivity / side effect infant influenza / drug therapy / prevention major clinical study male measles / drug therapy / prevention meningococcosis / drug therapy / prevention middle aged mucocutaneous lymph node syndrome / side effect newborn papillomavirus infection / drug therapy / prevention pneumococcal infection / drug therapy / prevention polyarteritis nodosa / side effect preschool child priority journal purpura / side effect rheumatic polymyalgia / side effect Rotavirus infection / drug therapy / prevention school child skin disease / side effect skin tuberculosis / side effect temporal arteritis / side effect tetanus / drug therapy / prevention *vaccination vasculitic rash / side effect *vasculitis / *side effect vasculitis / side effect virus infection / drug therapy / prevention yellow fever / drug therapy / prevention adult adolescent young adult aged anaphylactoid purpura / side effect arteritis / side effect Article bacterial infection / drug therapy / prevention Behcet disease / side effect brain vasculitis / side effect central nervous system disease / side effect |
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