title: Consumer reporting of adverse events following immunization.
abstract: Surveillance of adverse events following immunisation (AEFI) is an essential component of vaccine safety monitoring. The most commonly utilized passive surveillance systems rely predominantly on reporting by health care providers (HCP). We reviewed adverse event reports received in Victoria, Australia since surveillance commencement in July 2007, to June 2013 (6 years) to ascertain the contribution of consumer (vaccinee or their parent/guardian) reporting to vaccine safety monitoring and to inform future surveillance system development directions. Categorical data included were: reporter type; serious and non-serious AEFI category; and, vaccinee age group. Chi-square test and 2-sample test of proportions were used to compare categories; trend changes were assessed using linear regression. Consumer reporting increased over the 6 years, reaching 21% of reports received in 2013 (P<0.001), most commonly for children aged less than 7 years. Consumer reports were 5% more likely to describe serious AEFI than HCP (P=0.018) and 10% more likely to result in specialist clinic attendance (P<0.001). Although online reporting increased to 32% of all report since its introduction in 2010, 85% of consumers continued to report by phone. Consumer reporting of AEFI is a valuable component of vaccine safety surveillance in addition to HCP reporting. Changes are required to AEFI reporting systems to implement efficient consumer AEFI reporting, but may be justified for their potential impact on signal detection sensitivity.
authors.affiliation: SAEFVIC; Murdoch Childrens Research Institute; Melbourne; School of Population & Global Health; University of Melbourne; Melbourne, Victoria, Australia.
authors.forename: Hazel J
authors.initials: HJ
authors.lastname: Clothier
authors.forename: Gowri
authors.initials: G
authors.lastname: Selvaraj
authors.forename: Mee Lee
authors.initials: ML
authors.lastname: Easton
authors.forename: Georgina
authors.initials: G
authors.lastname: Lewis
authors.forename: Nigel W
authors.initials: NW
authors.lastname: Crawford
authors.forename: Jim P
authors.initials: JP
authors.lastname: Buttery
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D001315:Australia; D002648:Child; D006282:Health Personnel; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D008875:Middle Aged; D012017:Referral and Consultation
keywords: AEFI, Adverse event following immunization; HCP, Health care provider; adverse event; consumer; immunisation; safety; surveillance; vaccine