Appropriate medical treatment and supervision must be available to
manage possible 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
Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent
should be based on careful consideration of the potential benefits and
risks.
If Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose
Quadrivalent are administered to immunocompromised persons, including
those receiving immunosuppressive therapy, the immune response may be
lower than expected.
Vaccination with Fluzone Quadrivalent, Flublok Quadrivalent, and
Fluzone High-Dose Quadrivalent may not protect all recipients.
Syncope (fainting) has been reported following vaccination with
Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent. Procedures
should be in place to avoid injury from fainting.
For Fluzone Quadrivalent, in children 6 months through 35 months of
age, the most common injection-site reactions were pain or tenderness,
erythema, and swelling; the most common solicited systemic adverse
reactions were irritability, abnormal crying, malaise, drowsiness,
appetite loss, myalgia, vomiting, and fever. In children 3 years
through 8 years of age, the most common injection-site reactions were
pain, erythema, and swelling; the most common solicited systemic
adverse reactions were myalgia, malaise, and headache. In adults 18
years and older, the most common injection-site reaction was pain; the
most common solicited systemic adverse reactions were myalgia,
headache, and malaise.
For Flublok Quadrivalent, in adults 18 through 49 years of age, the
most common injection-site reactions were tenderness and pain; the
most common solicited systemic adverse reactions were headache,
fatigue, myalgia, and arthralgia. In adults 50 years of age and older,
the most common injection-site reactions were tenderness and pain; the
most common solicited systemic adverse reactions were headache and
fatigue.
For Fluzone High-Dose Quadrivalent, 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, headache,
and malaise.
For Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose
Quadrivalent, other adverse reactions may occur.
