Side Effects of Meruvax II (rubella vaccine)

Meruvax II (rubella vaccine) is a live attenuated (weakened) vaccine of the rubella virus used to prevent rubella infection (German measles).

Rubella is a highly contagious viral disease. In children, the disease is usually mild with fever and a rash. However, rubella is especially dangerous during pregnancy as it can cause miscarriage or serious birth defects. Rubella can be prevented with vaccination.

The vaccine works by stimulating the immune system to produce antibodies against the rubella virus. Meruvax II is no longer available in the U.S. and has been replaced with the measles, mumps, and rubella vaccine (MMR). The measles, mumps, and rubella vaccine is a single injection that contains all three vaccines, providing protection from all three infections.

Common side effects of Meruvax II include:

• fever,
• headache,
• dizziness,
• tiredness,
• irritability,
• diarrhea,
• vomiting,
• nausea,
• decreased platelet count,
• increased white blood cell count,
• allergic reactions,
• muscle pain,
• joint pain,
• numbness,
• rash, and
• eye problems.

Serious side effects of Meruvax II include:

• brain infection,
• Guillain-Barré syndrome,
• deafness, and
• death.

Drug interactions of Meruvax II include the tuberculin (TB) test.

Anyone who has had a life-threatening allergic reaction to gelatin should not receive Meruvax II.

Anyone who has had a life-threatening allergic reaction to the antibiotic neomycin should not receive Meruvax II because neomycin is used in the production process.

Patients with a weak immune system should not receive Meruvax II, including AIDS patients, patients receiving medicines that suppress the immune system, and people with cancer.

It is unknown if Meruvax II can cause birth defects. It should be avoided during pregnancy. Meruvax II passes into breast milk and should be used cautiously in breastfeeding mothers.

• Fever
• Headache
• Dizziness
• Tiredness
• Irritability
• Diarrhea
• Vomiting
• Nausea
• Decrease in platelet count
• Increase in white blood cell count
• Allergic reactions
• Muscle pain
• Joint pain
• Brain infection
• Guillain-Barré syndrome
• Numbness
• Rash
• Deafness
• Eye problems
• Death

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 rubella:

Body as a Whole

Fever; syncope; headache; dizziness; malaise; irritability.

Cardiovascular System

Vasculitis.

Digestive System

Diarrhea; vomiting; nausea.

Hemic and Lymphatic System

Thrombocytopenia; purpura; regional 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.

Musculoskeletal System

Arthritis; arthralgia; myalgia.

• 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: 12-26%) 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 women older than 35 years, these reactions are generally well tolerated and rarely interfere with normal activities. Myalgia and paresthesia have been reported rarely after administration of Meruvax (rubella virus vaccine live) II.

Nervous System

Encephalitis; Guillain-Barré syndrome (GBS); polyneuritis; polyneuropathy; paresthesia.

Respiratory System

Sore throat; cough; rhinitis.

Skin

Stevens-Johnson syndrome; erythema multiforme; urticaria; rash; pruritis

Local reactions including burning/stinging at injection site; wheal and flare; redness (erythema); pain; induration.

Special Senses — Ear

Nerve deafness; otitis media.

Special Senses — Eye

Optic neuritis; papillitis; retrobulbar neuritis; conjunctivitis.

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.
• 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.
• A VAERS report form as well as information regarding reporting requirements can be obtained by calling VAERS 1-800-822-7967. 31. Vaccine Adverse Event Reporting System — United States, MMWR 39(41): 730-733, October 19, 1990.

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.
• The ACIP has stated 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 rubella vaccine."

Immune Globulin

• Administration of immune globulins concurrently with Meruvax (rubella virus vaccine live) II may interfere with the expected immune response.