The adverse reactions associated with the use of M-M-R II vaccine are those which have been reported following administration of the monovalent or combination vaccines.
Common: Burning and/or stinging of short duration at the injection site.
Occasional: Body as a Whole: Fever (101°F [38.3°C] or higher).
Skin: Rash or measles-like rash usually minimal but may be generalized. Generally, fever, rash or both appear between the 5th and the 12th days.
Rare: Body as a Whole: Mild local reactions eg, erythema, induration and tenderness; sore throat, malaise, atypical measles, syncope, irritability.
Digestive: Parotitis, nausea, vomiting, diarrhea.
Hematologic/Lymphatic: Regional lymphadenopathy, thrombocytopenia, purpura.
Hypersensitivity: Allergic reactions eg, wheal and flare at injection site, anaphylaxis and anaphylactoid reactions, as well as related phenomena eg, angioneurotic edema (including peripheral or facial edema) and bronchial spasm, urticaria in individuals with or without an allergic history.
Musculoskeletal: Arthralgia and/or arthritis (usually transient and rarely chronic [see following text]), myalgia.
Nervous/Psychiatric: Febrile convulsions in children, afebrile convulsions or seizures, headache, dizziness, paresthesia, polyneuritis, Guillain-Barre syndrome, ataxia, aseptic meningitis (see following text), measles inclusion body encephalitis (MIBE) (see Contraindications).
Encephalitis/encephalopathy have been reported approximately once for every 3 million doses. In no case has it been shown that reactions were actually caused by vaccine. The risk of such serious neurological disorders following live measles virus vaccine administration remains far less than that for encephalitis and encephalopathy with wild-type measles (1/2000 reported cases).
Respiratory System: Pneumonia, pneumonitis (see Contraindications), cough, rhinitis.
Skin: Erythema multiforme, Stevens-Johnson syndrome, vesiculation at injection site, swelling, pruritis.
Special Senses: Forms of optic neuritis, including retrobulbar neuritis, papillitis and retinitis; ocular palsies, otitis media, nerve deafness, 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 in healthy individuals (see Contraindications). 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.
Arthralgia and/or arthritis (usually transient and rarely chronic) and polyneuritis are features of infection with wild-type rubella and vary in frequency and severity with age and sex, being greatest in adult females and least in prepubertal children.
Chronic arthritis has been associated with infection with wild-type 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.
Post-marketing surveillance of the >200 million doses of M-M-R and M-M-R II that have been distributed worldwide over 25 years (1971-1996) indicates that serious adverse events such as encephalitis and encephalopathy continue to be rarely reported.
There have been reports of subacute sclerosing panencephalitis (SSPE) in children who did not have a history of infection with wild-type measles but did receive measles vaccine. Some of these cases may have resulted from unrecognized measles in the 1st 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 1 case per million vaccine doses distributed. This is far less than the association with infection with wild-type measles, 6-22 cases of SSPE per million cases of measles. The results of a retrospective case-controlled study conducted by the Centers for Disease Control and Prevention suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE.
Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination. Although a causal relationship between the Urabe strain of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn mumps vaccine to aseptic meningitis.
Panniculitis has been reported rarely following administration of measles vaccine.