tetano
Editor, Senior Moderator
Vaccine. 2015 Sep 18. pii: S0264-410X(15)01293-1. doi: 10.1016/j.vaccine.2015.09.027. [Epub ahead of print]
[h=1]Spontaneous reports of vasculitis as an adverse event following immunization: A descriptive analysis across three international databases.[/h] Felicetti P[SUP]1[/SUP], Trotta F[SUP]2[/SUP], Bonetto C[SUP]2[/SUP], Santuccio C[SUP]2[/SUP], Pernus YB[SUP]3[/SUP], Burgner D[SUP]4[/SUP], Chandler R[SUP]5[/SUP], Girolomoni G[SUP]6[/SUP], Hadden RD[SUP]7[/SUP], Kochar S[SUP]8[/SUP], Kukucu M[SUP]9[/SUP], Monaco G[SUP]10[/SUP], Ozen S[SUP]11[/SUP], Pahud B[SUP]12[/SUP], Phuong L[SUP]13[/SUP], Bachtiar NS[SUP]14[/SUP], Teeba A[SUP]15[/SUP], Top K[SUP]16[/SUP], Varricchio F[SUP]17[/SUP], Wise RP[SUP]18[/SUP], Zanoni G[SUP]19[/SUP], ?ivkovic S[SUP]20[/SUP], Bonhoeffer J[SUP]21[/SUP]; Brighton Collaboration Vasculitis Working Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Vasculitides have been reported as adverse events following immunization (AEFI) following various vaccines. We describe reports of vasculitis to three international spontaneous reporting systems.
[h=4]METHODS:[/h] 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[SUP]?[/SUP]. 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.
[h=4]RESULTS:[/h] We retrieved 1797 reports of vasculitis in EV, 1171 in VAERS, and 2606 in VigiBase[SUP]?[/SUP]. 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.
[h=4]CONCLUSION:[/h] 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. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Adverse event following immunization (AEFI); Eudravigilance; Immunization; Pharmacovigilance; Spontaneous reporting; VAERS; Vaccines; Vasculitis; VigiBase(?)
PMID: 26392009 [PubMed - as supplied by publisher]
[h=1]Spontaneous reports of vasculitis as an adverse event following immunization: A descriptive analysis across three international databases.[/h] Felicetti P[SUP]1[/SUP], Trotta F[SUP]2[/SUP], Bonetto C[SUP]2[/SUP], Santuccio C[SUP]2[/SUP], Pernus YB[SUP]3[/SUP], Burgner D[SUP]4[/SUP], Chandler R[SUP]5[/SUP], Girolomoni G[SUP]6[/SUP], Hadden RD[SUP]7[/SUP], Kochar S[SUP]8[/SUP], Kukucu M[SUP]9[/SUP], Monaco G[SUP]10[/SUP], Ozen S[SUP]11[/SUP], Pahud B[SUP]12[/SUP], Phuong L[SUP]13[/SUP], Bachtiar NS[SUP]14[/SUP], Teeba A[SUP]15[/SUP], Top K[SUP]16[/SUP], Varricchio F[SUP]17[/SUP], Wise RP[SUP]18[/SUP], Zanoni G[SUP]19[/SUP], ?ivkovic S[SUP]20[/SUP], Bonhoeffer J[SUP]21[/SUP]; Brighton Collaboration Vasculitis Working Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Vasculitides have been reported as adverse events following immunization (AEFI) following various vaccines. We describe reports of vasculitis to three international spontaneous reporting systems.
[h=4]METHODS:[/h] 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[SUP]?[/SUP]. 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.
[h=4]RESULTS:[/h] We retrieved 1797 reports of vasculitis in EV, 1171 in VAERS, and 2606 in VigiBase[SUP]?[/SUP]. 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.
[h=4]CONCLUSION:[/h] 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. Published by Elsevier Ltd.
[h=4]KEYWORDS:[/h] Adverse event following immunization (AEFI); Eudravigilance; Immunization; Pharmacovigilance; Spontaneous reporting; VAERS; Vaccines; Vasculitis; VigiBase(?)
PMID: 26392009 [PubMed - as supplied by publisher]