Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of the vaccine.
If Guillain-Barré syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone, Flublok, or Fluzone High-Dose should be based on careful consideration of the potential benefits and risks.
If Fluzone, Flublok, or Fluzone High-Dose are administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be attained.
Vaccination with Fluzone, Flublok, or Fluzone High-Dose may not protect all recipients.
Syncope (fainting) has been reported following vaccination with Fluzone, Flublok and Fluzone High-Dose. Procedures should be in place to avoid injury from fainting.
For Fluzone, in children 6 months through 8 years of age, the most common injection-site adverse reactions were pain or tenderness and redness; the most common solicited systemic adverse reactions were irritability, drowsiness (6 months through 35 months), and myalgia (3 years through 8 years). In adults 18 through 64 years of age, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were headache and myalgia. In adults over 65 years of age, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were headache, myalgia, and malaise.
For Flublok, in adults 18 through 64 years of age, the most common injection site adverse reaction was pain; the most common solicited systemic adverse reactions were headache, fatigue, and myalgia. In adults 65 years of age and older, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were fatigue and headache.
For Fluzone High-Dose, in adults 65 years of age and older, the most common injection-site reaction was pain; the most common solicited systemic adverse reactions were myalgia, malaise, and headache.
For Fluzone, Flublok, and Fluzone High-Dose, other adverse reactions may occur.
