Measles, Mumps and Rubella Vaccines (MMR)

Adverse Events After MMR Vaccination

Adverse events associated with administration of MMR vaccine range from local pain, induration, and edema to rare systemic reactions such as anaphylaxis. Side effects tend to occur among vaccine recipients who are nonimmune and therefore are very rare after revaccination. Expert committees at the Institute of Medicine (IOM) recently reviewed all evidence concerning the causal relationship between MMR vaccination and various adverse events. The IOM determined that evidence establishes a causal relation between MMR vaccination and anaphylaxis, thrombocytopenia, febrile seizures, and acute arthritis. Although vasculitis, otitis media, conjunctivitis, optic neuritis, ocular palsies, Guillain-Barre syndrome, and ataxia have been reported after administration of MMR or its component vaccines and are listed in the manufacturer's package insert, no causal relationship has been established between these events and MMR vaccination.

Evidence does not support a causal association of administration of measles-containing vaccine with risk for Crohn disease, a hypothesis proposed by some researchers in the United Kingdom and Sweden. Other researchers have been unable to replicate the laboratory findings that were reported to support this hypothesized association. Concerns also have been raised about the methods used in the epidemiologic studies that suggested an association between Crohn disease and measles vaccination. Other data do not support an association between measles vaccination and risk for Crohn disease or other inflammatory bowel disease.

Infection with mumps virus may trigger the onset of diabetes mellitus in some persons. However, no association has been established between vaccination with MMR or other mumps virus vaccine and pancreatic damage or subsequent development of diabetes mellitus. Fever, Rash, Lymphadenopathy, or Parotitis

Measles, rubella, and mumps vaccines may cause fever after vaccination; the measles component of MMR vaccine is most often associated with this adverse event. Approximately 5% of children develop a temperature of greater than or equal to 103 F (greater than or equal to 39.4 C) after MMR vaccination. Such febrile reactions usually occur 7-12 days after vaccination and generally last 1-2 days. Most persons with fever are otherwise asymptomatic.

Measles- and rubella-containing vaccines (including MMR) can cause transient rashes, which usually appear 7-10 days after vaccination, in approximately 5% of vaccinated persons. Transient lymphadenopathy sometimes occurs following administration of MMR or other rubella-containing vaccine, and parotitis has been reported rarely following administration of MMR or other mumps-containing vaccine. Allergic Reactions

Hypersensitivity reactions, usually consisting of urticaria or a wheal and flare at the injection site, occur rarely after administration of MMR or any of its component vaccines. Immediate anaphylactic reactions to these vaccines are very rare. More than 70 million doses of MMR vaccine have been distributed in the United States since the Vaccine Adverse Events Reporting System (VAERS) was implemented in 1990. The reported rate of possible anaphylaxis after vaccination with measles-containing vaccine is less than 1 case per 1 million doses distributed (CDC, unpublished data). Allergic reactions including rash, pruritus, and purpura have been temporally associated with mumps vaccination but are uncommon, usually mild, and of brief duration. Thrombocytopenia

Surveillance of adverse reactions in the United States and other countries indicates that MMR vaccine can, in rare instances, cause clinically apparent thrombocytopenia within 2 months after vaccination. In prospective studies, the reported frequency of clinically apparent thrombocytopenia after MMR vaccination ranged from 1 case per 30,000 vaccinated children in Finland and Great Britain to 1 case per 40,000 in Sweden, with a temporal clustering of cases occurring 2-3 weeks after vaccination. Based on passive surveillance, the reported frequency of thrombocytopenia was approximately 1 case per 100,000 vaccine doses distributed in Canada and France, and approximately 1 case per 1 million doses distributed in the United States. The clinical course of these cases was usually transient and benign, although hemorrhage occurred rarely. The risk for thrombocytopenia during rubella or measles infection is much greater than the risk after vaccination. Based on case reports, the risk for MMR-associated thrombocytopenia may be increased for persons who have previously had immune thrombocytopenic purpura, particularly for those who had thrombocytopenic purpura after an earlier dose of MMR vaccine. Neurological Events

Adverse neurological events after administration of MMR vaccine are rare. Reports of nervous system illness following MMR vaccination do not necessarily denote an etiologic relationship between the illness and the vaccine. Although several cases of sensorineural deafness have been reported after administration of MMR vaccine, evidence from these case reports (e.g., timing of onset and other features) is inadequate to accept or reject a causal relation between MMR vaccination and sensorineural deafness. Aseptic Meningitis

Aseptic meningitis has been clearly associated with administration of the Urabe strain mumps vaccine virus but not with the Jeryl Lynn strain, which is the only mumps vaccine used in the United States. Sentinel surveillance laboratories in the United Kingdom identified thirteen aseptic meningitis cases (91 cases per 1 million doses distributed) that occurred after administration of the Urabe strain vaccine during 1988-1992. Since the United Kingdom switched to Jeryl Lynn strain vaccine in 1992, no mumps vaccine-associated aseptic meningitis cases have been reported by the surveillance laboratories. Subacute Sclerosing Panencephalitis (SSPE)

Measles vaccination substantially reduces the occurrence of SSPE as evidenced by the near elimination of SSPE cases after widespread measles vaccination. SSPE has been reported rarely among children who had no history of natural measles infection, but who had received measles vaccine. Evidence indicates that at least some of these children had unrecognized measles infection before they were vaccinated and that the SSPE was directly related to the natural measles infection. The administration of live measles vaccine does not increase the risk for SSPE, even among persons who have previously had measles disease or received live measles vaccine. Encephalopathy/Encephalitis

Encephalitis with resultant residual permanent central nervous system (CNS) impairment (encephalopathy) develops in approximately 1 per 1,000 persons infected with measles virus. Whether attenuated live viral measles vaccine can also produce such a syndrome has been a concern since the earliest days of measles vaccine use. In 1994, the IOM noted that most data were from case reports, case series, or uncontrolled observational studies, and concluded that the evidence was inadequate to accept or reject a causal relation.

The British National Childhood Encephalopathy Study (NCES) identified a fourfold elevation in risk for encephalopathy or convulsions among children who received measles vaccine during 1976-1979, compared with the risk for these conditions among unvaccinated children. Among previously normal children, the attributable risk for acute encephalopathy or convulsions was 1 case per 87,000 vaccinations. Findings of a subsequent 10-year follow-up study of persons diagnosed with convulsions or acute encephalopathy in the NCES indicated little difference in risk for persisting neurological abnormality among those who had received measles vaccine compared with those who had not (E. Miller, personal communication).

Although cases of encephalopathy have been reported after administration of measles-containing vaccine, lack of a unique clinical syndrome or specific laboratory test has hampered causality assessment. However, four independent passive surveillance systems in the United States (i.e., CDC measles surveillance from 1963 to 1971, the Monitoring System for Adverse Events Following Immunizations {MSAEFI} from 1979 to 1990, the Vaccine Adverse Event Reporting System {VAERS} from 1991 to 1996, and the Vaccine Injury Compensation Program {VICP}) have reported cases of encephalopathy in which a similar timing of reported events following vaccine administration is apparent. In all four case series, onset of encephalopathies follows a non-random distribution with onset approximately 10 days after vaccination, a timing consistent with onset of encephalopathy after infection with wild measles virus. Although this pattern may be in part attributable to consistent biases of these passive surveillance systems, it is also consistent with a causal relationship between measles vaccine and encephalopathies. During the period these four systems have collected data, 166 cases of encephalopathy occurring 6-15 days after vaccination have been identified and an estimated 313 million doses of measles-containing vaccines have been distributed (i.e., approximately 1 case per 2 million doses distributed). Thus, encephalopathy occurs much less frequently after administration of measles vaccine than after measles infection. Febrile Seizures and Personal and Family History of Convulsions

MMR vaccination, like other causes of fever, may cause febrile seizures. The risk for such seizures is approximately 1 case per 3,000 doses of MMR vaccine administered. Studies have not established an association between MMR vaccination and residual seizure disorders. Although children with personal or family histories of seizures are at increased risk for idiopathic epilepsy, febrile seizures after vaccinations do not increase the probability that epilepsy or other neurologic disorders will subsequently develop in these children. Most convulsions that occur after measles vaccination are simple febrile seizures, which affect children who do not have other known risk factors for seizure disorders.

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