Background: During the 2000-2001 season, an oculorespiratory syndrome (ORS) was identified in association with 1 manufacturer's influenza vaccine in Canada. ORS included bilateral red eyes, facial edema or respiratory symptoms beginning within 24 hours of influenza immunization. Few reports involved children. We assessed the rate of ORS in a pediatric cohort.
Methods: In February 2001, invitation to participate in an influenza vaccine safety survey was sent to the parents of children who attend a diabetes clinic. A questionnaire elicited influenza immunization history and adverse event experience beginning within 1 day of vaccination for the child with diabetes and up to 3 siblings. Follow-up telephone interviews collected information from those who failed to return a questionnaire by mail.
Results: Of the 959 households sent a questionnaire, 780 participated (81%). Among 780 children with diabetes, 418 (54%) received influenza vaccine in 2000. Adverse event experience was collected from an additional 242 immunized siblings. Among immunized children, 13% (95% confidence interval, 10-16%) experienced ORS, consisting primarily of respiratory symptoms. The majority (72%) resolved within 2 days. There was association between ORS and first time receipt of influenza vaccine (OR 2.7; 95% confidence interval, 1.6-4.4). Fewer parents of ORS-affected compared with unaffected children indicated that they were likely or very likely to have their child revaccinated (87 versus 97%; P < 0.001).
Conclusions: In 2000-2001, children experienced ORS in Canada at a rate comparable with that of adults. ORS should be incorporated into influenza vaccine safety monitoring and discussed with parents, especially those contemplating influenza vaccine for their child for the first time.