Varivax Side Effects

Generic name: varicella virus vaccine

Note: This document contains side effect information about varicella virus vaccine. Some of the dosage forms listed on this page may not apply to the brand name Varivax.

Some side effects of Varivax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to varicella virus vaccine: subcutaneous powder for injection

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. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with chickenpox is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction while taking varicella virus vaccine (the active ingredient contained in Varivax) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• cough, tight feeling in your chest, breathing problems;

• seizure (black-out or convulsions);

• easy bruising or bleeding, unusual weakness;

• behavior changes; or

• high fever (within a few hours or a few weeks after the vaccine).

Less serious side effects include:

• redness, pain, or swelling where the shot was given;

• low fever;

• mild skin rash;

• runny or stuffy nose, cough, sore throat;

• headache, tired feeling;

• sleep problems (insomnia);

• joint or muscle pain; or

• nausea, vomiting, stomach pain, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to varicella virus vaccine: subcutaneous powder for injection

General

The most frequent side effects have included fever, injection site reactions, and varicella-like rash.

Local

Local side effects have included injection site pain, soreness, swelling, erythema, rash, pruritus, hematoma, induration, and stiffness in 19.3% of patients and a varicella-like rash at the injection in 3.8% of patients.

Other

Other side effects have included fever with oral temperature >=102 degrees F (39 degrees C) and febrile seizures (in <0.1% of children).

Dermatologic

Dermatologic side effects have included rash, contact rash, heat rash/prickly heat, eczema/dry skin/dermatitis, and itching; however, causality was not determined. A generalized varicella-like rash has been reported in 5.5% of adolescents and adults within 7 to 21 days after the first dose and in 0.9% within 0 to 23 days after the second dose. Stevens-Johnson syndrome, erythema multiforme, Henoch-Schoenlein purpura, secondary bacterial skin and soft tissue infections including impetigo and cellulitis, and herpes zoster have also been reported.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, loss of appetite, vomiting, teething, abdominal pain, nausea, and constipation; however, causality was not determined.

Hypersensitivity

Hypersensitivity reactions have included anaphylaxis, allergic rash, and hives.

Hematologic

Hematologic side effects have included thrombocytopenia.

Immunologic

Immunologic side effects have included chronic disseminated verrucous skin lesions associated with a herpes zoster infection which developed in a child who received immunosuppressive chemotherapy starting 5 days postvaccination. The herpes zoster infection developed 3 months after initiation of chemotherapy and then developed into verrucous lesions. DNA isolated from a lesion biopsy revealed the presence of the Oka vaccine strain of varicella virus, which was acyclovir-resistant.

Musculoskeletal

Musculoskeletal side effects have included myalgia and arthralgia; however, causality was not determined.

Nervous system

Nervous system side effects have included irritability, nervousness, fatigue, and disturbed sleep; however, causality was not determined. Encephalitis, cerebrovascular accident, transverse myelitis, Guillain-Barre syndrome, Bell's palsy, ataxia, nonfebrile seizures, dizziness, and paresthesia have also been reported.

Respiratory

Respiratory side effects have included upper and lower respiratory illness, cough, and pneumonitis (in <1% of children); however, causality was not determined.

Other

Headache, lymphadenopathy, otitis, eye complaints, and stiff neck have also been reported; however, causality was not determined.

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