title: Lack of evidence for claims of farmers in south-eastern Germany regarding adverse reactions ascribed to BTV-8 vaccines.
abstract: Farmers in south-eastern Germany who claimed adverse reactions due to the application of BTV-8 vaccines during the compulsory vaccination programme in 2008/2009 were invited to participate in an epidemiological study to prove whether there was evidence for a plausible relationship between the immunizations and the reported symptoms. Ten farms were available for on-site visits; all other farmers (N = 120) who had registered to participate in the study were asked to complete a questionnaire and to provide evidence for the claimed adverse reactions. 25 questionnaires were returned. Although a wide range of symptoms were reported, in most cases the documentation of clinical signs, pathological alterations and fatalities was not sufficient to conclude on a causal relationship. Similarly, most of the suspected adverse events evaluated as pharmacovigilance reports had to be categorized as "unclassified due to insufficient information".
authors.affiliation: Friedrich-Loeffler-Institut, Wusterhausen. carolina.probst@fli.bund.de
authors.forename: Carolina
authors.initials: C
authors.lastname: Probst
authors.forename: Jörn M
authors.initials: JM
authors.lastname: Gethmann
authors.forename: Detlef
authors.initials: D
authors.lastname: Höreth-Böntgen
authors.forename: Klaus
authors.initials: K
authors.lastname: Cussler
authors.forename: Franz J
authors.initials: FJ
authors.lastname: Conraths
mesh_terms: D000818:Animals; D001819:Bluetongue / Q000517:prevention & control; D001820:Bluetongue virus; D002417:Cattle; D002418:Cattle Diseases / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control; D005858:Germany / Q000453:epidemiology; D007114:Immunization / Q000009:adverse effects / Q000706:statistics & numerical data / Q000662:veterinary*; D060735:Pharmacovigilance; D011795:Surveys and Questionnaires; D014765:Viral Vaccines / Q000009:adverse effects / Q000592:standards*
chemical_list: D014765:Viral Vaccines