Recommended Topic Related To:

Fluzone

"Dec. 3, 2012 -- The U.S. flu season is here -- the earliest start since the "moderately severe" season of 2003.

Just as in 2003, the nasty H3N2 flu bug is causing most cases so far.

"This could be a bad flu year," warned CDC"...

Fluzone

Fluzone Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Fluzone (influenza virus) Vaccine is 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. It is a "killed virus" vaccine. Common side effects include soreness/redness/swelling/bruising at the injection site that may last for up to 1-2 days. Fever, muscle aches, headache or weakness may also occur.

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

Our Fluzone (influenza virus) Vaccine Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Fluzone in Detail - Patient Information: Side Effects

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

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 after receiving this vaccine. If you ever need to receive influenza virus vaccine in the future, you will need to tell your doctor if the previous shot caused any side effects.

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

Call your doctor at once if you have:

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

Common side effects may include:

  • low fever, chills;
  • mild fussiness or crying;
  • redness, bruising, pain, swelling, or a lump where the vaccine was injected;
  • headache, tired feeling; or
  • joint or muscle pain.

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.

Read the entire detailed patient monograph for Fluzone (Influenza Virus Vaccine) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Fluzone FDA Prescribing Information: Side Effects
(Adverse Reactions)

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.

Children 6 Months through 8 Years of Age

In a multi-center study conducted in the US, children 6 months through 35 months of age received two 0.25 mL doses of Fluzone, and children 3 years through 8 years of age received two 0.5 mL doses of Fluzone, irrespective of previous influenza vaccination history. The two doses (20062007 formulation) were administered 26 to 30 days apart. The safety analysis set included 97 children 6 months through 35 months of age and 163 children 3 years through 8 years of age. Table 2 and Table 3 summarize solicited injection site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards.

Table 2: Frequency of Solicited Injection Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone, Children 6 Through 35 Months of Age

  Dose 1
(Na=90-92) Percentage
Dose 2
(Na=86-87) Percentage
Any Moderateb Severec Any Moderateb Severec
Injection-Site Tenderness 47.3 8.8 0.0 56.3 3.4 1.1
Injection-Site Erythema 29.3 0.0 0.0 32.2 1.1 0.0
Injection-Site Swelling 16.7 0.0 0.0 14.9 0.0 0.0
Injection-Site Induration 14.4 0.0 0.0 16.1 0.0 0.0
Injection-Site Ecchymosis 14.4 1.1 0.0 14.9 2.3 0.0
Feverd 11.0 4.4 0.0 10.3 3.4 1.1
Vomiting 6.6 1.1 0.0 8.1 5.8 0.0
Crying Abnormal 31.9 11.0 0.0 18.6 7.0 2.3
Drowsiness 26.4 1.1 0.0 26.7 4.7 0.0
Appetite Lost 23.1 8.8 0.0 19.8 5.8 1.2
Irritability 42.9 19.8 1.1 34.9 17.4 4.7
a N is the number of vaccinated subjects with available data for the events listed
b Moderate - Injection-site tenderness: cries and protests when injection site is touched; Injection-site erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 2.5 cm to < 5 cm; Fever: > 101.3°F to ≤ 103.1°F; Vomiting: 2 to 5 episodes per 24 hours; Crying abnormal: 1 to 3 hours; Drowsiness: not interested in surroundings or did not wake up for a meal; Appetite lost: missed 1 or 2 feeds completely; Irritability: requiring increased attention
c Severe - Injection-site tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Injection-site erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 5 cm; Fever: > 103.1°F; Vomiting: ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: > 3 hours; Drowsiness: sleeping most of the time or difficulty to wake up; Appetite lost: refuses ≥ 3 feeds or refuses most feeds; Irritability: inconsolable
d Fever - Any Fever: ≥ 100.4°F. The percentage of temperature measurements that were taken by rectal, axillary, or oral routes, or not recorded were 69.2%, 17.6%, 13.2%, and 0.0%, respectively, for Dose 1; and 69.0%, 13.8%, 16.1%, and 1.1%, respectively, for Dose 2

Table 3: Frequency of Solicited Injection Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone, Children 3 Through 8 Years of Age

  Dose 1
(Na=150-151) Percentage
Dose 2
(Na=144-145) Percentage
Any Moderateb Severec Any Moderateb Severec
Injection-Site Pain 59.3 8.0 0.0 62.1 9.7 0.7
Injection-Site Erythema 27.8 3.3 0.7 27.6 2.1 0.7
Injection-Site Swelling 19.9 5.3 0.0 14.5 2.8 0.0
Injection-Site Induration 16.6 2.0 0.0 11.7 1.4 0.0
Injection-Site Ecchymosis 12.6 0.7 0.7 15.2 0.7 0.0
Injection-Site Pruritus 7.3 - - 13.2 - -
Feverd 11.9 2.6 2.0 9.7 1.4 1.4
Headache 16.7 2.0 0.7 11.8 1.4 1.4
Malaise 20.0 2.7 1.3 14.6 4.2 0.7
Myalgia 28.0 5.3 0.0 17.4 4.2 0.0
a N is the number of vaccinated subjects with available data for the events listed
b Moderate - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injectionsite erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 2.5 cm to < 5 cm; Fever: > 100.4°F to ≤ 102.2°F; Headache, Malaise, and Myalgia: interferes with daily activities
c Severe - Injection-site pain: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Injection-site erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 5 cm; Fever: > 102.2°F; Headache, Malaise, and Myalgia: prevents daily activities
d Fever - Any Fever: ≥ 99.5°F. The percentage of temperature measurements that were taken by oral or axillary routes, or not recorded were 93.4%, 6.6%, and 0.0%, respectively, for Dose 1; and 93.1%, 6.2%, and 0.7%, respectively, for Dose 2
“-” Indicates information was not collected

During the period from the first vaccination through 6 months following the second vaccination, there were no serious adverse events considered to be caused by vaccination and no deaths reported in this study.

Adults

Adults 18 through 64 years of age received Fluzone (2008-2009 formulation) in a multi-center trial conducted in the US. The safety analysis set included 1421 Fluzone recipients. Table 4 summarizes solicited injection-site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards.

Table 4: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone, Adults 18 Through 64 Years of Age

  (Na=1392-1394)
Percentage
Any Grade 2b Grade 3c
Injection-Site Erythema 13.2 2.1 0.9
Injection-Site Induration 10.0 2.3 0.5
Injection-Site Swelling 8.4 2.1 0.9
Injection-Site Pain 53.7 5.8 0.8
Injection-Site Pruritus 9.3 0.4 0.0
Injection-Site Ecchymosis 6.2 1.1 0.4
Headache 30.3 6.5 1.6
Myalgia 30.8 5.5 1.4
Malaise 22.2 5.5 1.8
Shivering 6.2 1.1 0.6
Feverd 2.6 0.4 0.2
a N is the number of vaccinated subjects with available data for the events listed
b Grade 2 - Injection-site erythema, Injection-site induration, Injection-site swelling, and Injection-site ecchymosis: ≥ 2.5 cm to < 5 cm; Injection-site pain and Injection-site pruritus: sufficiently discomforting to interfere with normal behavior or activities; Fever: > 100.4°F to ≤ 102.2°F; Headache, Myalgia, Malaise, and Shivering: interferes with daily activities
c Grade 3 - Injection-site erythema, Injection-site induration, Injection-site swelling, and Injection-site ecchymosis: ≥ 5 cm; Injection-site pain: incapacitating, unable to perform usual activities; Injection-site pruritus: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Fever: > 102.2°F; Headache, Myalgia, Malaise, and Shivering: prevents daily activities
d Fever - Any Fever: ≥ 99.5°F. The percentage of temperature measurements that were taken by oral or axillary routes, or not recorded were 99.6%, 0.0%, and 0.4%, respectively

Within 28 days and 6 months post-vaccination, a serious adverse event was reported by 5 (0.4%) and 20 (1.4%) Fluzone recipients, respectively. No serious adverse event was considered to be caused by vaccination. No deaths were reported during the 6 months post-vaccination.

Geriatric Adults

Adults 65 years of age and older received Fluzone (2006-2007 formulation) in a multi-center, double-blind trial conducted in the US. The safety analysis set included 1260 Fluzone recipients.

Table 5 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.

Table 5: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone, Adults 65 Years of Age and Older

  Na=1258-1260
Percentage
Any Moderateb Severec
Injection-Site Pain 24.3 1.7 0.2
Injection-Site Erythema 10.8 0.8 0.6
Injection-Site Swelling 5.8 1.3 0.6
Myalgia 18.3 3.2 0.2
Malaise 14.0 3.7 0.6
Headache 14.4 2.5 0.3
Feverd 2.3 0.2 0.1
a N is the number of vaccinated subjects with available data for the events listed
b 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
c Severe - Injection-site pain: incapacitating, unable to perform usual activities; Injection-site erythema and Injectionsite swelling: ≥ 5 cm; Fever: > 102.2°F; Myalgia, Malaise, and Headache: prevents daily activities
d Fever - Any Fever: ≥ 99.5°F. The percentage of temperature measurements that were taken by oral route or not recorded were 98.6% and 1.4%, respectively

Within 6 months post-vaccination, 93 (7.4%) Fluzone recipients experienced a serious adverse event (N=1260). No deaths were reported within 28 days post-vaccination. A total of 7 deaths were reported during the period Day 29-180 post-vaccination: 7 (0.6%) among Fluzone recipients (N=1260). The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. No deaths were considered to be caused by vaccination.

Post-Marketing Experience

The following events have been spontaneously reported during the post-approval use of Fluzone. 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.

Read the entire FDA prescribing information for Fluzone (Influenza Virus Vaccine) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Living Better

Find the secrets to longer life.