M-R-VAX II SIDE EFFECTS

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 M-R-VAX (measles and rubella 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; 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. Afebrile convulsions or seizures have occurred rarely following vaccination with live attenuated measles vaccine. 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, papillitis, and retinitis 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 measles and rubella virus vaccines given individually indicates that encephalitis and other nervous system reactions have occurred very rarely. These might occur also with M-R-VAX (measles and rubella virus vaccine live) II.

Experience from more than 80 million doses of all live measles vaccines given in the U.S. through 1975 indicates that significant central nervous system reactions such as encephalitis and encephalopathy, occurring within 30 days after vaccination, have been temporally associated with measles vaccine very rarely. In no case has it been shown that reactions were actually caused by vaccine. The Center for Disease Control has pointed out that “a certain number of cases of encephalitis may be expected to occur in a large childhood population in a defined period of time even when no vaccines are administered”. However, the data suggest the possibility that some of these cases may have been caused by measles vaccines. The risk of such serious neurological disorders following live measles virus vaccine administration remains far less than that for encephalitis and encephalopathy with natural measles (one per two thousand reported cases).

There have been rare reports of ocular palsies, Guillain-Barr© syndrome, or ataxia occurring after immunization with vaccines containing live attenuated measles virus. The ocular palsies have occurred approximately 3-24 days following vaccination. No definite causal relationship has been established between these events and vaccination. Isolated reports of polyneuropathy including Guillain-Barr© syndrome have also been reported after immunization with rubella-containing vaccines.

There have been reports of subacute sclerosing panencephalitis (SSPE) in children who did not have a history of natural measles but did receive measles vaccine. Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination. Based on estimated nationwide measles vaccine distribution, the association of SSPE cases to measles vaccination is about one case per million vaccine doses distributed. This is far less than the association with natural measles, 6-22 cases of SSPE per million cases of measles. The results of a retrospective case-controlled study conducted by the Center for Disease Control suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE.

Local reactions characterized by marked swelling, redness and vesiculation at the injection site of attenuated live measles virus vaccines, and systemic reactions including atypical measles, have occurred in persons who received killed measles vaccine previously. M-R-VAX (measles and rubella virus vaccine live) II was not given under this condition in clinical trials. Rarely, more severe reactions that require hospitalization, including prolonged high fevers and extensive local reactions, have been reported. Panniculitis has been reported rarely following administration of measles vaccine.

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.