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The following adverse reactions are listed in decreasing order of severity, without regard to causality, within each body system category and have been reported during clinical trials, with use of the marketed vaccine, or with use of polyvalent vaccine containing mumps:

Body as a Whole

Fever; syncope; irritability.

Cardiovascular System

Vasculitis.

Digestive System

Pancreatitis; diarrhea; parotitis.

Endocrine System

Diabetes mellitus.

Hemic and Lymphatic System

Thrombocytopenia; purpura; lymphadenopathy; leukocytosis.

Immune System

Anaphylaxis and anaphylactoid reactions have been reported as well as related phenomena such as angioneurotic edema (including peripheral or facial edema) and bronchial spasm in individuals with or without an allergic history.

Nervous System

Encephalitis; Guillain-Barré Syndrome (GBS); febrile seizures; ocular palsies.

Cases of aseptic meningitis have been reported to VAERS following measles, mumps, and rubella vaccination. Although a causal relationship between the Urabe strain of mumps vaccine and aseptic meningitis has been shown, there are no data to link Jeryl Lynn mumps vaccine to aseptic meningitis.

Respiratory System

Cough; rhinitis.

Skin

Stevens-Johnson Syndrome; erythema multiforme; urticaria.

Local reactions including burning/stinging at injection site; wheal and flare.

Special Senses — Ear

Nerve deafness; otitis media.

Special Senses — Eye

Optic neuritis; papillitis; retrobulbar neuritis; conjunctivitis.

Urogenital System

Orchitis.

Other

Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established. No deaths or permanent sequelae were reported in a published post-marketing surveillance study in Finland involving 1.5 million children and adults who were vaccinated with M-M-R II during 1982-1993.³³

Under the National Childhood Vaccine Injury Act of 1986, health-care providers and manufacturers are required to record and report certain suspected adverse events occurring within specific time periods after vaccination. However, the U.S. Department of Health and Human Services (DHHS) has established a Vaccine Adverse Event Reporting System (VAERS) which will accept all reports of suspected events.³² A VAERS report form as well as information regarding reporting requirements can be obtained by calling VAERS 1-800-822-7967.

See DOSAGE AND ADMINISTRATION, Use With Other Vaccines.

Immunosuppressive Therapy

The immune status of patients about to undergo immunosuppressive therapy should be evaluated so that the physician can consider whether vaccination prior to the initiation of treatment is indicated (see CONTRAINDICATIONS and PRECAUTIONS). The ACIP has indicated that patients with leukemia in remission who have not received chemotherapy for at least 3 months may receive live virus vaccines. Short-term ( < 2 weeks), low- to moderate-dose systemic corticosteroid therapy, topical steroid therapy (e.g., nasal, skin), long-term alternate-day treatment with low to moderate doses of short-acting systemic steroid, and intra-articular, bursal, or tendon injection of corticosteroids are not immunosuppressive in their usual doses and do not contraindicate the administration of mumps vaccine.¹⁶

Immune Globulin

Administration of immune globulins concurrently with MUMPSVAX (mumps virus vaccine live) may interfere with the expected immune response.^16,29

See also PRECAUTIONS, General.

REFERENCES

16. Recommendations of the Immunization Practices Advisory Committee (ACIP), Mumps Prevention, MMWR 38(22): 388-400, June 9, 1989.

29. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatrics, 344-357, 1997.

32. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, Oct. 19, 1990.

32. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, Oct. 19, 1990.

33. Peltola, H.; et al.: The elimination of indigenous measles, mumps, and rubella from Finland by a 12-year, two dose vaccination program, N. Engl. J. Med. 331: 1397-1402, 1994.

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.