M-M-R II Side Effects

The adverse reactions associated with the use of M-M-R II 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 day.
Rare: Body as a whole: Mild local reactions such as erythema, induration and tenderness; sore throat, malaise, atypical measles, irritability.
Cardiovascular: Vasculitis.
Digestive: Parotitis, nausea, vomiting, diarrhea.
Hematologic/Lymphatic: Regional lymphadenopathy, thrombocytopenia, purpura.
Hypersensitivity: Allergic reactions such as wheal and flare at injection site, anaphylaxis and anaphylactoid reactions, as well as related phenomena such as 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 as follows]), myalgia.
Nervous/Psychiatric: Febrile convulsions in children, afebrile convulsions or seizures, headache, dizziness, paresthesia, polyneuritis, polyneuropathy, Guillain-Barre syndrome, ataxia, acute disseminated encephalomyelitis (ADEM), transverse myelitis, aseptic meningitis (see as follows), measles inclusion body encephalitis (MIBE) (see Contraindications), encephalitis/encephalopathy (see as follows), syncope.
Respiratory System: Pneumonia, pneumonitis (see Contraindications), cough, rhinitis.
Skin: Erythema multiforme, Stevens-Johnson syndrome, Henoch-Schönlein purpura, Acute Hemorrhagic Edema of Infancy, vesiculation at injection site, swelling, pruritus.
Special senses: Forms of optic neuritis, including retrobulbar neuritis, papillitis, and retinitis; ocular palsies, otitis media, nerve deafness, conjunctivitis.
Urogenital: Epididymitis, 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 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 to 1993.
Unknown Frequency: Skin: Skin granuloma associated with vaccine derived rubella virus.
Arthralgia and/or arthritis: 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.
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 adult women. Even in older women (35 to 45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Subacute Sclerosing Panencephalitis (SSPE): There have been reports of 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 to 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.
Aseptic meningitis: 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.
Encephalitis/encephalopathy: Encephalitis/encephalopathy have been reported approximately once for every 3 million doses of the measles, mumps, and rubella vaccine manufactured by Merck Sharp & Dohme LLC, Rahway, NJ 07065 USA. Since 1978, post-marketing surveillance indicates that serious adverse events such as encephalitis and encephalopathy continue to be rarely reported. 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 (one per one thousand reported cases).
In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported (see Contraindications); disseminated mumps and rubella vaccine virus infection have also been reported.
Panniculitis: Panniculitis has been reported rarely following administration of measles vaccine.
In a randomized open-label clinical trial (NCT00432523), conducted in France and Germany, 752 children 12 months through 18 months of age received M-M-R II concomitantly administered with VARIVAX at a separate site, by either the intramuscular (n=374) or subcutaneous (n=378) route. In the overall population, 55.3% were male and the median age was 13.2 months. Local and systemic solicited adverse reactions were recorded by parents or guardians using standardized diary cards. Local solicited reactions were recorded for 4 days after vaccination, and systemic solicited adverse reactions were recorded for 42 days after vaccination. In the event that a participant experienced a rash or a mumps-like illness, parents and/or guardians were instructed to contact the investigator for an examination as soon as possible and no later than 72 hours following onset of symptoms. The nature of any rash was characterized by principal investigator either as a measles-like, rubella-like, varicella-like or "other". Study investigators reviewed the diary card with the participant or participant's legal guardian 42 days after vaccination to ensure consistency with protocol definitions. Table as follows presents the frequency of solicited adverse reactions based on the final assessment by the study investigators. (See table.)

Click on icon to see table/diagram/image

Unsolicited adverse events that occurred within 42 days following vaccination were recorded using diary cards supplemented by medical review. Data on unsolicited adverse events were transcribed into the study database during an on-site visit at day 42. The rates and types of reported adverse events (AEs) across groups were similar and included common clinical events that are often reported in the evaluated populations. Serious adverse events occurred at rates of 0.3% and 1% in the intramuscular and subcutaneous groups, respectively. One moderate intensity case of otitis media occurred in a participant in the subcutaneous group was considered related to the study vaccination.