Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is not approved for use in children <24 months of age. In a clinical trial with FluMist, among children 6-23 months of age, wheezing requiring bronchodilator therapy or with significant respiratory symptoms occurred in 5.9% of FluMist recipients compared to 3.8% of active control (injectable influenza vaccine made by Sanofi Pasteur Inc.) recipients (Relative Risk 1.5, 95% CI: 1.2, 2.1). Wheezing was not increased in children ≥24 months of age. Hypersensitivity, including anaphylactic reaction, has been reported during post-marketing experience with FluMist.
Food and Drug Administration
Food and Drug Administration
Novartis Influenza A (H1N1) 2009 Monovalent Vaccine Insert
Anaphylaxis has been reported after administration of FLUVIRIN. Although FLUVIRIN and Influenza A (H1N1) 2009 Monovalent Vaccine contain only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis. The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than 1 additional case/1 million persons vaccinated.
Food and Drug Administration
Sanofi Pasteur Influenza A (H1N1) 2009 Monovalent Vaccine Insert
Anaphylaxis has been reported after administration of influenza vaccines. Although Influenza A (H1N1) 2009 Monovalent Vaccine contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis. The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than 1 additional case/1 million persons vaccinated. Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported.
Food and Drug Administration
CSL Influenza A (H1N1) 2009 Monovalent Vaccine Insert
Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. The adverse reactions described have been included in this section because they: 1) represent reactions that are known to occur following immunizations generally or influenza immunizations specifically; 2) are potentially serious; or 3) have been reported frequently.