Fluzone Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Fluzone?

Fluzone (influenza virus) Vaccine is a "killed virus" vaccine used to prevent infection caused by influenza virus. The vaccine is redeveloped each year to contain specific strains of inactivated (killed) flu virus that are recommended by public health officials for that year.

What Are Side Effects of Fluzone?

Common side effects of Fluzone include:

injection site reactions (soreness, redness, swelling, bruising pain, or a lump) that may last for up to 1-2 days,
fever,
chills,
joint or muscle aches or pain,
headache,
tired feeling,
weakness, or
fussiness or crying in children.

Call your doctor at once if you have side effects of Fluzone including:

severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine),
high fever,
seizures (convulsions), or
unusual bleeding.

Dosage for Fluzone

The dosing of Fluzone is determined by the patient's age. Dosing is either 0.25 mL/Intramuscular, or 0.5 mL/Intramuscular, given in either one dose, or given as 2 doses at least 1 month apart.

What Drugs, Substances, or Supplements Interact with Fluzone?

Fluzone Vaccine may interact with phenytoin, theophylline, blood thinners, steroid medicines, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medicines to treat or prevent organ transplant rejection. Tell your doctor all medications and supplements you use.

Fluzone During Pregnancy or Breastfeeding

During pregnancy, Fluzone should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Fluzone (influenza virus) Vaccine Drug Center provides a comprehensive view of available drug information as well as related drugs, user reviews, supplements, and diseases and conditions articles.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

A Cold or The Flu? How to Tell the Difference See Slideshow

Fluzone Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

You should not receive a booster vaccine if you had a life threatening allergic reaction after the first shot.

Keep track of any and all side effects you have. If you receive an influenza virus vaccine in the future, you will need to tell the vaccination provider if the previous shot caused any side effects.

Influenza virus vaccine is made from "killed viruses" and will not cause you to become ill with the flu virus. You may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

Call your doctor at once if you have:

a light-headed feeling, like you might pass out;
severe weakness or unusual feeling in your arms and legs;
numbness, pain, tingling, burning or prickly feeling;
vision or hearing problems; or
a fever higher than 101 degrees F.

Common side effects may include:

pain, redness, tenderness, swelling, bruising, or a hard lump where the shot was given;
diarrhea, loss of appetite;
muscle pain;
headache, tiredness; or
fussiness, crying, or drowsiness in a child.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

QUESTION

Which illness is known as a viral upper respiratory tract infection? See Answer

Fluzone Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice.

Two clinical studies have evaluated the safety of Fluzone High-Dose.

Study 1 (NCT00391053, see http://clinicaltrials.gov) was a multi-center, double-blind pre-licensure trial conducted in the US. In this study, adults 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone (2006-2007 formulation). The study compared the safety and immunogenicity of Fluzone High-Dose to those of Fluzone. The safety analysis set included 2573 Fluzone High-Dose recipients and 1260 Fluzone recipients.

Table 1 summarizes solicited injection-site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards. Onset was usually within the first 3 days after vaccination and a majority of the reactions resolved within 3 days. Solicited injection-site reactions and systemic adverse events were more frequent after vaccination with Fluzone High-Dose compared to Fluzone.

Table 1: Study 1 : Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone High-Dose or Fluzone, Adults 65 Years of Age and Older

	Fluzone High-Dose (N^† =2569-2572) Percentage			Fluzone (N^† =1258-1260) Percentage
	Any	Moderate^‡	Severe^§	Any	Moderate^‡	Severe^§
Injection-Site Pain	35.6	3.7	0.3	24.3	1.7	0.2
Injection-Site Erythema	14.9	1.9	1.8	10.8	0.8	0.6
Injection-Site Swelling	8.9	1.6	1.5	5.8	1.3	0.6
Myalgia	21.4	4.2	1.6	18.3	3.2	0.2
Malaise	18.0	4.7	1.6	14.0	3.7	0.6
Headache	16.8	3.1	1.1	14.4	2.5	0.3
Fever ^¶(≥99.5°F)	3.6	1.1	0.0	2.3	0.2	0.1
*NCT00391053 ^†N is the number of vaccinated participants with available data for the events listed ^‡Moderate - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injectionsite erythema and Injection-site swelling: ≥2.5 cm to <5 cm; Fever: >100.4 °F to ≤102.2°F; Myalgia, Malaise, and Headache: interferes with daily activities ^§Severe - Injection-site pain: incapacitating, unable to perform usual activities; Injection-site erythema and Injection-site swelling: ≥5 cm; Fever: >102.2°F; Myalgia, Malaise, and Headache: prevents daily activities ^¶Fever - The percentage of temperature measurements that were taken by oral route or not recorded were 97.9% and 2.1%, respectively, for Fluzone High-Dose; and 98.6% and 1.4 %, respectively, for Fluzone

Within 6 months post-vaccination, 156 (6.1%) Fluzone High-Dose recipients and 93 (7.4%) Fluzone recipients experienced a serious adverse event (SAE). No deaths were reported within 28 days postvaccination. A total of 23 deaths were reported during Days 29 – 180 post-vaccination: 16 (0.6%) among Fluzone High-Dose recipients and 7 (0.6%) among Fluzone recipients. The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluzone High-Dose.

Study 2 (NCT01427309, see http://clinicaltrials.gov) was a multi-center, double-blind post-licensure efficacy trial conducted in the US and Canada over two influenza seasons. In this study, adults 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone (2011-2012 and 2012-2013 formulations). The study compared the efficacy and safety of Fluzone High-Dose to those of Fluzone. The safety analysis set included 15,992 Fluzone High-Dose recipients and 15,991 Fluzone recipients.

Within the study surveillance period (approximately 6 to 8 months post-vaccination), 1323 (8.3%) Fluzone High-Dose recipients and 1442 (9.0%) Fluzone recipients experienced an SAE. Within 30 days post-vaccination, 204 (1.3%) Fluzone High-Dose recipients and 200 (1.3%) Fluzone recipients experienced an SAE. The majority of these participants had one or more chronic comorbid illnesses. A total of 167 deaths were reported within 6 to 8 months post-vaccination: 83 (0.5%) among Fluzone High-Dose recipients and 84 (0.5%) among Fluzone recipients. A total of 6 deaths were reported within 30 days post-vaccination: 6 (0.04%) among Fluzone High-Dose recipients and 0 (0 %) among Fluzone recipients. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluzone High-Dose.

Post-Marketing Experience

The following events have been spontaneously reported during the post-approval use of Fluzone or Fluzone High-Dose. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone or Fluzone High- Dose.

Events Reported During Post-Approval Use of Fluzone

Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy
Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
Eye Disorders: Ocular hyperemia
Nervous System Disorders: Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell's palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia
Vascular Disorders: Vasculitis, vasodilatation/flushing
Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis, cough, wheezing, throat tightness
Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome
General Disorders and Administration Site Conditions: Pruritus, asthenia/fatigue, pain in extremities, chest pain
Gastrointestinal Disorders: Vomiting