Published online June 1, 2006
PEDIATRICS Vol. 117 No. 6 June 2006, pp. 1963-1971 (doi:10.1542/10.1542/peds.2005-2607)

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Solicited Adverse Events After Influenza Immunization Among Infants, Toddlers, and Their Household Contacts

Danuta M. Skowronski, MD^a, Karen Jacobsen, CRA^b, Jocelyne Daigneault, RN, MSc^c, Valencia P. Remple, RN, MSN^a, Linda Gagnon, RN, MSN^c, Patricia Daly, MD^d, Gillian Arsenault, MD^e, Monique Landry, MD^f, Karen Pielak, RN, MSN^a, Bernard Duval, MD^g, Theresa Tam, MBBS^h and Gaston De Serres, MD^g

^a British Columbia Centre for Disease Control, Vancouver, British Columbia, Canada
^b Westcoast Clinical Research, Coquitlam, British Columbia, Canada
^c Direction de Santé Publique, Chicoutimi, Quebec, Canada
^d Vancouver Coastal Health Authority, Vancouver, British Columbia, Canada
^e Fraser Health Authority, Surrey, British Columbia, Canada
^f Direction Générale de la Santé Publique, Ministère de la Santé et des Services Sociaux du Québec, Québec, Québec, Canada
^g Institut National de Santé Publique du Québec, Québec, Québec, Canada
^h Public Health Agency of Canada, Ottawa, Ontario, Canada

OBJECTIVES. We assessed adverse events, including oculorespiratory syndrome, following influenza immunization during the first year of a publicly-funded program for infants, toddlers and their household members in Canada.

METHODS. Parents bringing infants and toddlers for influenza immunization to clinics in Quebec or British Columbia consented to structured telephone interview 5 to 10 days later. One adult provided information for all household members. Symptom experience commencing before and after immunization was assessed. Non-immunized persons also served as a comparison group for immunized household members.

RESULTS. Sample included 690 immunized infants and toddlers and 1801 household members, 1374 immunized. Only fussiness, fever, decreased appetite, drowsiness, and nasal congestion/coryza were reported for >5% of infants/ toddlers within 72 hours of immunization, but only arm discomfort was reported among >5% of immunized household contacts. In multivariate analysis, muscle ache was the only systemic symptom reported more often by immunized household members compared to non-immunized persons. Oculorespiratory symptoms were infrequent and there was no difference between immunized and non-immunized household members in their report. Less than 1% of adults required time off work because of adverse events following influenza immunization in the household. Less than 2% of subjects experiencing an adverse event following influenza immunization were considered unlikely to be vaccinated again.

CONCLUSION. Influenza vaccine is well-tolerated by infants, toddlers and their household members. Post-marketing observational designs are an expedient way to assess adverse events following influenza immunization. These methods should be established and rehearsed annually in preparation for a pandemic.

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Key Words: influenza • trivalent inactivated vaccine • immunization • adverse events • infants • toddlers

Abbreviations: ORS—oculorespiratory syndrome • AEFII—adverse event following influenza immunization • TIV—trivalent inactivated vaccine • OR—odds ratio • CI—confidence interval

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Accepted Dec 27, 2005.

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