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. 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.
For illustrative purposes only.
