Initial U.S. Approval: 20XX*
[I]ndicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses… [and] approved for use in persons 65 years of age and older.
CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, including egg protein.
Unsolicited non-serious adverse events were reported in 279 (15.7%) recipients…
Within 180 days post-vaccination… 4.5%… experienced a serious adverse event (SAE).
Postmarketing Experience
– Thrombocytopenia, lymphadenopathy
– Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
– Ocular hyperemia
– Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia
– Vasculitis, vasodilatation
– Dyspnea, cough, wheezing, throat tightness, oropharyngeal pain, and rhinorrhea
– Vomiting
– Stevens-Johnson syndrome
– Pruritus, asthenia/fatigue, chest pain, chills
[P]repared from influenza viruses propagated in embryonated chicken eggs.
[C]hemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100)**…
Fluzone High-Dose Quadrivalent has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.
Inactive ingredients include formaldehyde and octylphenol ethoxylate.