Initial U.S. Approval: 2012
FLUARIX QUADRIVALENT is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses… approved for use in persons aged 6 months and older.
CONTRAINDICATIONS
History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein…
Unsolicited adverse events occurring within 28 days of any vaccination were reported in 31%…
Postmarketing Experience
– Lymphadenopathy
– Tachycardia
– Vertigo
– Conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling.
– Abdominal pain or discomfort, swelling of the mouth, throat, and/or tongue.
– Asthenia, chest pain, influenza-like illness, feeling hot, injection site mass, injection site reaction, injection site warmth, body aches.
– Anaphylactic reaction including shock, anaphylactoid reaction, hypersensitivity, serum sickness.
– Injection site abscess, injection site cellulitis, pharyngitis, rhinitis, tonsillitis.
– Convulsion, encephalomyelitis, facial palsy, facial paresis, Guillain-Barré syndrome, hypoesthesia, myelitis, neuritis, neuropathy, paresthesia, syncope.
– Asthma, bronchospasm, dyspnea, respiratory distress, stridor.
– Angioedema, erythema, erythema multiforme, facial swelling, pruritus, Stevens-Johnson syndrome, sweating, urticaria.
– Henoch-Schönlein purpura, vasculitis.
[P]ropagated in embryonated chicken eggs.
Each 0.5-mL dose… contains… polysorbate 80… may also contain residual amounts of hydrocortisone… ovalbumin…