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Abstract: Background:: Oculo-respiratory syndrome (ORS) following influenza vaccination was identified in Canada in 2000. This report describes trends of ORS reported during four consecutive seasons 2000, 2001, 2002 and 2003 in the province of Quebec, Canada. Methods:: Data come from the vaccine-associated adverse event (VAAE) passive reporting system of the Province of Quebec. Results:: The rate of ORS reported per 100000 doses distributed declined from 46.6 in 2000 to 34.2, 20.6 and 9 in 2001, 2002 and 2003, respectively. There was no significant difference in rates for ORS between the two vaccines in use in Canada (Fluviral and Vaxigrip) both in 2001 and 2002. During the 4 years, incidence was highest in people aged 40–59 years and declined in older age groups. The clinical profile of ORS has remained remarkably stable over years. Overall, ocular, respiratory symptoms or facial edema were reported by 58%, 84% and 31% of patients, respectively, and 15% had symptoms including all three symptom categories. ORS lasted more than a week in 8–13% of the cases. Conclusion:: ORS is an adverse event that occurred with both influenza vaccines used in Canada. Its frequency has declined substantially but is still present after 4 years. It constitutes a clinical entity distinct from anaphylactic allergy. Unlike anaphylaxis, ORS does not constitute an absolute contraindication to further doses. [Copyright &y& Elsevier]

Oculo-respiratory syndrome (ORS), a new influenza vaccine associated adverse event, was identified in 2000. The 2000 case definition (ORS-2000) required the presence of bilateral red eyes or respiratory symptoms or facial edema occurring between 2 and 24 h following immunization and lasting ≤48 h. We compared clinical manifestations of cases outside these timelines. Cases were classified as ORS-early (onset <2 h after immunization), ORS-late (onset >24 h), ORS-persistors (duration >48 h).Overall, the distribution of symptoms was similar between ORS-2000 and other case categories. ORS-early and ORS-late had less ocular involvement, ORS-late and ORS-persistors had more cough and sore throat, ORS-early had more facial edema and ORS-late had less. In comparison to ORS-2000, ORS-early were younger whereas ORS-persistors and ORS-late were significantly older suggesting that clinical manifestations of ORS vary with age with a more rapid induction of symptoms in younger individuals and longer duration for older ones. [Copyright &y& Elsevier]

We assessed the occurrence of oculo-respiratory syndrome (ORS) following two influenza vaccines: Fluviral® (Shire Biologics) or Vaxigrip® (Aventis Pasteur). ORS was identified amongst 5.3 and 4.6% of recipients, respectively (P=0.54). With both vaccines, the risk of ORS was much greater in individuals who had ORS the previous year (2000) than in those without such history. In multivariate analysis, the odds ratio for ORS for patients with a prior history of ORS varied between 9.4 and 9.6 (P<0.001) whereas that comparing Fluviral® and Vaxigrip® varied between 1.5 and 1.9 (P=0.02–0.05). ORS is an adverse event that is present with more than one vaccine and may be present with any influenza vaccines to a greater or lesser degree. [Copyright &y& Elsevier]

A syndrome of red eyes and respiratory symptoms was noted following receipt of influenza vaccine in Canada during the 2000–2001 influenza season. We conducted intra-dermal skin testing to determine if oculo-respiratory syndrome (ORS) was related to failure of the splitting process during vaccine manufacturing, if it was associated with a particular viral strain and to identify individuals at risk for subsequent ORS reaction. Skin testing with minute quantities of vaccine antigen induced ORS symptoms at a higher rate amongst persons previously affected by this syndrome compared to previously unaffected persons. Skin test reaction size or quality could not identify persons at risk of ORS. Skin testing could not identify a specific strain or the stage in the manufacturing process during which the trigger may have been introduced. [Copyright &y& Elsevier]