(MEASLES, MUMPS, and
RUBELLA VIRUS VACCINE LIVE)

ADVERSE REACTIONS
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 monovalent or bivalent vaccine containing measles, mumps, or rubella:
Body as a Whole
Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability.
Cardiovascular System
Vasculitis.
Digestive System
Pancreatitis; diarrhea; vomiting; parotitis; nausea.
Endocrine System
Diabetes mellitus.
Hemic and Lymphatic System
Thrombocytopenia (see WARNINGS, Thrombocytopenia); purpura; regional lymphadenopathy;
leukocytosis.
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Immune System
Anaphylaxis and anaphylactoid reactions have been reported as well as related phenomena such as
angioneurotic edema (including peripheral or ****** edema) and bronchial spasm in individuals with or
without an allergic history.
Musculoskeletal System
Arthritis; arthralgia; myalgia.
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 ***, 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.
Chronic arthritis has been associated 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: 12-26%),{17,56,57} 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.
Nervous System
Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) (see
CONTRAINDICATIONS); 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.
Encephalitis and encephalopathy have been reported approximately once for every 3 million doses of
M-M-R II or measles-, mumps-, and rubella-containing vaccine administered since licensure of these
vaccines.
The risk of serious neurological disorders following live measles virus vaccine administration remains
less than the risk of encephalitis and encephalopathy following infection with wild-type measles (1 per
1000 reported cases).{58,59}
In severely immunocompromised individuals who have been inadvertently vaccinated with measlescontaining vaccine; measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct
consequence of disseminated measles vaccine virus infection have been reported (see
CONTRAINDICATIONS). In this population, disseminated mumps and rubella vaccine virus infection have
also been 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 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 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.{60}
Cases of aseptic meningitis have been reported to VAERS 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.
Respiratory System
Pneumonia; pneumonitis (see CONTRAINDICATIONS); sore throat; cough; rhinitis.
Skin
Stevens-Johnson syndrome; erythema multiforme; urticaria; rash; measles-like rash; pruritis.
Local reactions including burning/stinging at injection site; wheal and flare; redness (erythema);
swelling; induration; tenderness; vesiculation at injection site; Henoch-Schönlein purpura; acute
hemorrhagic edema of infancy.
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Special Senses — Ear
Nerve deafness; otitis media.
Special Senses — Eye
Retinitis; optic neuritis; papillitis; retrobulbar neuritis; conjunctivitis.
Urogenital System
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.{61}
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.{49}
A VAERS report form as well as information regarding reporting requirements can be obtained by calling
VAERS 1-800-822-7967.