M-M-R II Adverse Reactions

The following adverse reactions include those identified during clinical trials or reported during post-approval use of M-M-R II vaccine or its individual components.
Body as a Whole: Panniculitis; atypical measles; fever; headache; dizziness; malaise; irritability.
Cardiovascular System: Vasculitis.
Digestive System: Pancreatitis; diarrhea; vomiting; parotitis; nausea.
Hematologic and Lymphatic Systems: Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis.
Immune System: Anaphylaxis, anaphylactoid reactions, angioedema (including peripheral or facial edema) and bronchial spasm.
Musculoskeletal System: Arthritis; arthralgia; myalgia.
Nervous System: Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE); subacute sclerosing panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM); transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis; polyneuropathy; ocular palsies; paresthesia; syncope.
Respiratory System: Pneumonia; pneumonitis; sore throat; cough; rhinitis.
Skin: Stevens-Johnson syndrome; acute hemorrhagic edema of infancy; Henoch-Schönlein purpura; erythema multiforme; urticaria; rash; measles-like rash; pruritus; injection site reactions (pain, erythema, swelling and vesiculation).
Special Senses - Ear: Nerve deafness; otitis media.
Special Senses - Eye: Retinitis; optic neuritis; papillitis; conjunctivitis.
Urogenital System: Epididymitis; orchitis.
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 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. The table 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.