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- Clinician Information:
Biavax Side Effects Center
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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Biavax FDA Prescribing Information: Side Effects
Burning and/or stinging of short duration at the injection site have been reported.
The adverse clinical reactions associated with the use of BIAVAX (rubella and mumps virus vaccine live) II are those expected to follow administration of the monovalent vaccines given separately. These may include malaise, sore throat, cough, rhinitis, headache, dizziness, fever, rash, nausea, vomiting or diarrhea; mild local reactions such as erythema, induration, tenderness and regional lymphadenopathy; parotitis, orchitis, nerve deafness, thrombocytopenia and purpura; allergic reactions such as wheal and flare at the injection site or urticaria; polyneuritis; and arthralgia and/or arthritis (usually transient and rarely chronic).
Anaphylaxis and anaphylactoid reactions have been reported.
Vasculitis has been reported rarely.
Moderate fever [101-102.9°F (38.3-39.4°C)] occurs occasionally, and high fever [above 103°F (39.4°C)] occurs less commonly. On rare occasions, children developing fever may exhibit febrile convulsions. Syncope, particularly at the time of mass vaccination, has been reported. Rash occurs infrequently and is usually minimal, but rarely may be generalized. Erythema multiforme has also been reported rarely.
Forms of optic neuritis, including retrobulbar neuritis and papillitis may infrequently follow viral infections, and have been reported to occur 1 to 3 weeks following inoculation with some live virus vaccines.
Clinical experience with live attenuated rubella and mumps virus vaccines given individually indicates that encephalitis and other nervous system reactions have occurred very rarely. These might occur also with BIAVAX (rubella and mumps virus vaccine live) II.
Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of natural rubella and vary in frequency and severity with age and sex, being greatest in adult females and least in prepubertal children. This type of involvement as well as myalgia and paresthesia have also been reported following administration of MERUVAX II (Rubella Virus Vaccine Live).
Chronic arthritis has been associated with natural rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues. Only rarely have vaccine recipients developed chronic joint symptoms.
Following vaccination in children, reactions in joints are uncommon and generally of brief duration. In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (children: 0-3%; women: 12-20%), and the reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of months or on rare occasions for years. In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and in adult women. Even in older women (35-45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Read the entire FDA prescribing information for Biavax (Rubella and Mumps Virus Vaccine Live) »
Additional Biavax Information
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