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2007-08 INFLUENZA PREVENTION & CONTROL RECOMMENDATIONS
Adverse Events After Receipt of TIV
NOTE: For 2008-09 Influenza Prevention and Control Recommendations see Prevention & Control of Influenza - Recommendations of the Advisory Committee on Immunization Practices (ACIP) 2008. MMWR 2008 Jul 17; Early Release:1-60. (Also available as PDF, 586K).
NOTE: The text below is taken directly from Prevention & Control of Influenza - Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2007 Jul 13;56(RR06):1-54. Also available as PDF (720K).
In placebo-controlled studies among adults, the most frequent side effect of vaccination was soreness at the vaccination site (affecting 10%–64% of patients) that lasted <2 days. These local reactions typically were mild and rarely interfered with the person’s ability to conduct usual daily activities. One study reported that 20%–28% of children with asthma aged 9 months–18 years had local pain and swelling at the site of influenza vaccination, and another study reported that 23% of children aged 6 months–4 years with chronic heart or lung disease had local reactions. A blinded, randomized, cross-over study of 1,952 adults and children with asthma demonstrated that only self-reported “body aches” were reported more frequently after TIV (25.1%) than placebo-injection (20.8%). However, a placebo-controlled trial of TIV indicated no difference in local reactions among 53 children aged 6 months–6 years with high-risk medical conditions or among 305 healthy children aged 3–12 years. A recent retrospective study using medical records data from approximately 45,000 children aged 6–23 months provided evidence supporting overall safety of TIV in this age group. Vaccination was not associated with statistically significant increases in any medically attended outcome, and 13 diagnoses, including acute upper respiratory illness, otitis media and asthma, were significantly less common.
Fever, malaise, myalgia, and other systemic symptoms can occur after vaccination with inactivated vaccine and most often affect persons who have had no previous exposure to the influenza virus antigens in the vaccine (e.g., young children). These reactions begin 6–12 hours after vaccination and can persist for 1–2 days. Recent placebo-controlled trials demonstrate that among older persons and healthy young adults, administration of split-virus influenza vaccine is not associated with higher rates of systemic symptoms (e.g., fever, malaise, myalgia, and headache) when compared with placebo injections.
In a randomized cross-over study of children and adults with asthma, no increase in asthma exacerbations was reported for either age group. An analysis of 215,600 children aged <18 years and 8,476 children aged 6–23 months enrolled in one of five health maintenance organizations (HMOs) during 1993–1999 reported no increase in biologically plausible, medically attended events during the 2 weeks after inactivated influenza vaccination, compared with control periods 3–4 weeks before and after vaccination. In a study of 791 healthy children aged 1–15 years, post-vaccination fever was noted among 11.5% of those aged 1–5 years, 4.6% among those aged 6–10 years, and 5.1% among those aged 11–15 years.
Among children with high-risk medical conditions, one study of 52 children aged 6 months–3 years reported fever among 27% and irritability and insomnia among 25%; and a study among 33 children aged 6–18 months reported that one child had irritability and one had a fever and seizure after vaccination. No placebo comparison group was used in these studies.
Data regarding potential adverse events after influenza vaccination are available from the Vaccine Adverse Event Reporting System (VAERS). During January 1991–June 2006, of 25,805 reports of adverse events received by VAERS, 5,727 (22%) concerned children aged <18 years, including 1,070 (4%) children aged 6–23 months. The number of influenza vaccine doses received by children during this entire period is unknown. A recently published review of VAERS reports submitted after administration of TIV to children aged 6–23 months documented that the most frequently reported adverse events were fever, rash, injection-site reactions, and seizures; the majority of the limited number of reported seizures appeared to be febrile. Because of the limitations of passive reporting systems, determining causality for specific types of adverse events, with the exception of injection-site reactions, usually is not possible using VAERS data alone. However, a population-based study of TIV safety in children aged 6–23 months who were vaccinated during 1993–1999 identified no adverse events that had a plausible relationship to vaccination.
Immediate and presumably allergic reactions (e.g., hives, angioedema, allergic asthma, and systemic anaphylaxis) occur rarely after influenza vaccination. These reactions probably result from hypersensitivity to certain vaccine components; the majority of reactions probably are caused by residual egg protein. Although current influenza vaccines contain only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Manufacturers use a variety of different compounds to inactivate influenza viruses and add antibiotics to prevent bacterial contamination. Package inserts should be consulted for additional information.
Persons who have had hives or swelling of the lips or tongue, or who have experienced acute respiratory distress or who collapse after eating eggs should consult a physician for appropriate evaluation to help determine if vaccine should be administered. Persons who have documented immunoglobulin E (IgE)-mediated hypersensitivity to eggs, including those who have had occupational asthma related to egg exposure or other allergic responses to egg protein, also might be at increased risk for allergic reactions to influenza vaccine, and consultation with a physician before vaccination should be considered.
Hypersensitivity reactions to vaccine components can occur but are rare. Although exposure to vaccines containing thimerosal can lead to hypersensitivity, the majority of patients do not have reactions to thimerosal when it is administered as a component of vaccines, even when patch or intradermal tests for thimerosal indicate hypersensitivity. When reported, hypersensitivity to thimerosal typically has consisted of local delayed hypersensitivity reactions.
- Page last updated October 23, 2007
- Content Source: Coordinating Center for Infectious Diseases (CCID)
- National Center for Immunization and Respiratory Diseases (NCIRD)
