Initial U.S. Approval: 2013
FLULAVAL 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…
6 [months] through 35 months…
Unsolicited adverse events occurring within 28 days of vaccination were reported in 46%…
The unsolicited adverse reactions that occurred most frequently (≥1%) for FLULAVAL QUADRIVALENT included upper respiratory tract infection, cough, diarrhea, pyrexia, vomiting, and rash.
Serious adverse events occurring during the study period (approximately 6 months) were reported in 2%…
3 through 8 years…
The frequency of unsolicited adverse events occurring within 28 days of vaccination was… 33%…
The unsolicited adverse reactions that occurred most frequently (≥1% for FLULAVAL QUADRIVALENT) included diarrhea, pyrexia, gastroenteritis, nasopharyngitis, upper respiratory tract infection, varicella, cough, and rhinorrhea.
Serious adverse events occurring within 28 days of any vaccination were reported in 0.7% of subjects who received FLULAVAL QUADRIVALENT…
3 through 17 years (mean age: 9 years)…
Unsolicited adverse events occurring within 28 days of vaccination were reported in 30%…
The unsolicited adverse reactions that occurred most frequently (≥1% for FLULAVAL QUADRIVALENT) included vomiting, pyrexia, bronchitis, nasopharyngitis, pharyngitis, upper respiratory tract infection, headache, cough, oropharyngeal pain, and rhinorrhea.
18 years and older (mean age: 50 years)…
Unsolicited adverse events occurring within 21 days of vaccination were reported in 19%…
The unsolicited adverse reactions that occurred most frequently (≥1% for FLULAVAL QUADRIVALENT) included nasopharyngitis, upper respiratory tract infection, headache, cough, and oropharyngeal pain.
Postmarketing Experience
– Lymphadenopathy.
– Eye pain, photophobia.
– Dysphagia, vomiting.
– Chest pain, injection site inflammation, asthenia, injection site rash, influenza-like symptoms, abnormal gait, injection site bruising, injection site sterile abscess.
– Allergic reactions including anaphylaxis, angioedema.
– Rhinitis, laryngitis, cellulitis.
– Muscle weakness, arthritis.
– Dizziness, paresthesia, hypoesthesia, hypokinesia, tremor, somnolence, syncope, Guillain-Barré syndrome, convulsions/seizures, facial or cranial nerve paralysis, encephalopathy, limb paralysis.
– Insomnia.
– Dyspnea, dysphonia, bronchospasm, throat tightness.
– Urticaria, localized or generalized rash, pruritus, sweating.
– Flushing, pallor.
…prepared from virus propagated in… embryonated hens’ eggs.
Each 0.5-mL dose may also contain residual amounts of ovalbumin… polysorbate 80…
FLULAVAL QUADRIVALENT has not been evaluated for carcinogenic, mutagenic potential, or male infertility in animals.