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

Applies to varicella virus vaccine: powder for suspension.

Serious side effects of Varivax

Along with its needed effects, varicella virus vaccine (the active ingredient contained in Varivax) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking varicella virus vaccine:

More common

• Fever over 39°C (102°F)

Less common

• Blue lips and fingernails
• chest pain or tightness
• chickenpox-like skin rash
• coughing that sometimes produces a pink frothy sputum
• decreased urine output
• difficult, fast, or noisy breathing
• dilated neck veins
• extreme tiredness or weakness
• general feeling of discomfort or illness
• increased sweating
• irregular breathing
• irregular heartbeat
• irritability
• pale skin
• swelling of the ankles, face, fingers, feet, or lower legs
• weight gain

Rare

• Black, tarry stools
• blood in the urine or stools
• chills
• confusion
• cough
• difficulty with breathing or swallowing
• fever
• hives
• itching, especially of the feet or hands
• muscle or joint pain
• pinpoint red spots on the skin
• reddening of the skin, especially around the ears
• seizures with high fever
• severe or continuing headache
• stiff neck
• swelling of the glands in the neck
• thickening of bronchial secretions
• unusual bleeding or bruising
• unusual tiredness or weakness, sudden and severe
• vomiting

Incidence not known

• Back pain, sudden and severe
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody nose
• blurred vision
• bruising more easily
• dizziness
• fast heartbeat
• headache
• heavier menstrual periods
• inability to move the arms and legs
• inability to speak
• large, flat, blue, or purplish patches in the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of bladder control
• muscle spasm or jerking of all extremities
• painful blisters on the trunk of the body
• painful knees and ankles
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• raised red swellings on the skin, buttocks, legs, or ankles
• red, irritated eyes
• red skin lesions, often with a purple center
• seizures
• shakiness and unsteady walk
• skin rash
• slurred speech
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain
• sudden loss of consciousness
• sudden numbness and weakness in the arms and legs
• swollen or painful glands
• temporary blindness
• tingling of the hands or feet
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual weight gain or loss
• weakness in the arm or leg on one side of the body, sudden and severe
• weakness of the muscles in your face

Other side effects of Varivax

Some side effects of varicella virus vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Fever of 37.7°C (100°F) or higher, but not above 39°C (102°F)
• hives, itching, pain, redness, soreness, tenderness, or warmth at the injection site

Less common

• Common cold
• congestion
• constipation
• cracked, dry, or scaly skin
• diaper rash
• diarrhea
• disturbed sleep
• dry skin
• earache
• heat rash or prickly heat
• lack or loss of strength
• loss of appetite
• muscle ache, cramp, or stiffness
• nausea
• nervousness
• runny nose
• skin rash, encrusted, scaly, and oozing
• sneezing
• sore throat
• stuffy nose
• swelling
• swollen joints
• teething

Incidence not known

• Bacterial skin infections
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• difficulty with moving
• dryness or soreness of the throat
• hoarseness
• pain, redness, swelling, tenderness, or warmth on the skin
• red rash with watery, yellow-colored, or pus-filled blisters
• thick yellow to honey-colored crusts
• voice changes

For Healthcare Professionals

Applies to varicella virus vaccine: injectable powder for injection, subcutaneous powder for injection.

General

The most common adverse events were injection site reactions and fever.^[Ref]

Other

Very common (10% or more): Fever (27%), otitis media (12%)

Uncommon (0.1% to 1%): Otitis, viral infection, asthenia, hematoma, malaise

Rare (less than 0.1%): Ear pain, infection, candidiasis, non-venomous bite/sting, heaviness

Frequency not reported: Insect bites^[Ref]

Local

Very common (10% or more): Injection site complaints (pain/soreness, swelling and/or erythema, rash, pruritus, hematoma, induration, stiffness) (32.5%)

Common (1% to 10%): Varicella-like rash (injection site)

Uncommon (0.1% to 1%): Injection site ecchymosis, induration

Rare (less than 0.1%): Extravasation, injection site eczema, lump, warmth, stiffness, pain/tenderness/soreness, warm sensation, warm to touch, venipuncture site hemorrhage^[Ref]

Respiratory

Very common (10% or more): Upper respiratory infection (26.9%), cough (11%)

Common (1% to 10%): Rhinorrhea

Uncommon (0.1% to 1%): Nasal congestion, respiratory congestion, influenza, pharyngitis

Rare (less than 0.1%): Pneumonitis, sinusitis, sneezing, pulmonary congestion, epistaxis, rhinitis, wheezing, bronchitis, respiratory infection, pneumonia, flu-like illness

Frequency not reported: Upper respiratory illness, lower respiratory illness^[Ref]

Dermatologic

Common (1% to 10%): Varicella-like rash (generalized), rash, measles/rubella-like rash

Uncommon (0.1% to 1%): Varicella, viral exanthema, contact dermatitis, diaper rash, erythema, miliaria rubra, pruritus, urticaria

Rare (less than 0.1%): Flushing, vesicle, atopic dermatitis, eczema, acne, herpes simplex, contusion, dermatitis, drug eruption, impetigo, skin infection, measles, sunburn, lump, warmth, discoloration, inflammation, roughness/dryness, hive-like rash, hyperpigmentation

Postmarketing reports: Varicella (vaccine strain), Stevens-Johnson syndrome, erythema multiforme, Henoch-Schonlein purpura, secondary bacterial infections of skin and soft tissue including cellulitis, herpes zoster^[Ref]

Psychiatric

Common (1% to 10%): Irritability

Uncommon (0.1% to 1%): Crying, insomnia, sleep disorder

Rare (less than 0.1%): Apathy, nervousness, agitation, dream abnormality, emotional changes

Frequency not reported: Disturbed sleep^[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Gastroenteritis, diarrhea, vomiting

Rare (less than 0.1%): Abdominal pain, nausea, flatulence, hematochezia, mouth ulcer, lip abnormality

Frequency not reported: Constipation, cold/canker sore^[Ref]

Nervous system

Uncommon (0.1% to 1%): Headache, somnolence, fatigue

Rare (less than 0.1%): Febrile seizures, hypersomnia, gait abnormality, tremor

Postmarketing reports: Encephalitis, cerebrovascular accident, transverse myelitis, Guillain-Barré syndrome, Bell's palsy, ataxia, non-febrile seizures, aseptic meningitis, dizziness, paresthesia^[Ref]

Hematologic

Rare (less than 0.1%): Lymphadenopathy, lymphadenitis, thrombocytopenia

Postmarketing reports: Aplastic anemia, idiopathic thrombocytopenic purpura^[Ref]

Hypersensitivity

Frequency not reported: Allergic reactions (including allergic rash, hives)

Postmarketing reports: Anaphylaxis (including anaphylactic shock) and related phenomena such as angioneurotic edema, facial edema, and peripheral edema; anaphylaxis in individuals with or without an allergic history^[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis

Rare (less than 0.1%): Acute conjunctivitis, tearing, edema of the eyelid, irritation

Frequency not reported: Eye complaints

Postmarketing reports: Necrotizing retinitis (in immunocompromised individuals)^[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia^[Ref]

Musculoskeletal

Rare (less than 0.1%): Musculoskeletal pain, myalgia, stiffness, pain of the hip, leg, or neck

Frequency not reported: Chills, stiff neck, arthralgia^[Ref]