Measles, Mumps, and Rubella Vaccine

Live, attenuated virus vaccine.1 11 Measles, mumps, and rubella virus vaccine live (MMR) is a fixed-combination vaccine containing measles, mumps, and rubella antigens and is used to stimulate active immunity to measles, mumps, and rubella.1 MMR also commercially available in the US as a fixed-combination vaccine containing measles, mumps, rubella, and varicella antigens (MMRV; ProQuad).66

Contraindications

MMR (M-M-RII) or MMRV (ProQuad)

• Hypersensitivity to the vaccine or any component, including gelatin.1 66 (See Gelatin Allergy under Cautions.)

• History of anaphylactic or anaphylactoid reaction to neomycin.1 66 (See Neomycin Allergy under Cautions.)

• Blood dyscrasias, leukemia, lymphomas of any type, or any other malignant neoplasms affecting the bone marrow or lymphatic system.1 66 (See Individuals with Altered Immunocompetence under Cautions.)

• Primary and acquired immunodeficiencies, including acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of HIV infection, cellular immune deficiency, hypogammaglobulinemia, and dysgammaglobulinemia.1 66 (See Individuals with Altered Immunocompetence under Cautions.)

• Immunosuppressive therapy (e.g., corticosteroids, antineoplastic agents, radiation).1 66 (See Specific Drugs and Laboratory Tests under Interactions.)

• Family history of congenital or hereditary immunodeficiency, unless immune competence has been demonstrated in the potential vaccine recipient.1 66 (See Individuals with Altered Immunocompetence under Cautions.)

• Febrile respiratory illness or other active febrile infection.1 66 (See Concomitant Illness under Cautions.)

• Active untreated tuberculosis.1 66 (See Tuberculosis under Cautions.)

• Pregnancy.1 66 (See Pregnancy under Cautions.)

Warnings/Precautions

Warnings

Because MMR and MMRV (ProQuad) contain live, attenuated viruses, they generally are contraindicated in individuals with altered immunocompetence, including those with primary or acquired immunodeficiencies or those receiving immunosuppressive therapy.1 8 11 50 66 (See Contraindications.)

Measles inclusion body encephalitis (MIBE), pneumonitis, and death related to disseminated measles vaccine virus infection have been reported in individuals with altered immunocompetence (e.g., AIDS) who received measles-containing vaccines.1 31 32 44

MMR is contraindicated in HIV-infected children, adolescents, and adults with evidence of severe immunosuppression (i.e., children <12 months of age with CD4+ T-cell count <750/mm3; children 1 through 5 years of age with CD4+ T-cell count <500/mm3; children ≥6 years of age, adolescents, and adults with CD4+ T-cell count <200/mm3; children <13 years of age with CD4+ T-cell percentage <15%).1 31 32 44 75 76 However, HIV-infected individuals are at increased risk for severe complications if infected with measles.11 31 32 44 76 Therefore, ACIP, AAP, NIH, IDSA, Pediatric Infectious Diseases Society, and others state that MMR can be used in HIV-infected children, adolescents, and adults who do not have evidence of severe immunosuppression.8 11 14 15 31 32 44 75 76 Do not use MMRV (ProQuad) in HIV-infected individuals;27 66 76 safety and efficacy of this fixed-combination vaccine not established in such individuals.66

ACIP states use of live virus vaccines can be considered in patients with leukemia, lymphoma, or other malignancies if the disease is in remission and chemotherapy was terminated at least 3 months prior to vaccination.11

Antibody responses to MMR and efficacy may be decreased in immunocompromised individuals.1 31 42 44

The presence of immunocompromised or HIV-infected individuals in a household does not preclude administration of MMR or MMRV (ProQuad) to other household members.8 14 27 44

Encephalitis, encephalopathy, MIBE, subacute sclerosing panencephalitis (SSPE), Guillain-Barré syndrome (GBS), aseptic meningitis, seizures, ataxia, polyneuritis, polyneuropathy, ocular palsies, and paresthesia reported rarely.1 44

Adverse CNS reactions (encephalitis, encephalopathy) have been temporally associated with MMR, but causal relationship not established.1 44 Risk of serious neurologic disorders following measles vaccination is considerably less than the risk of encephalitis and encephalopathy associated with wild-type measles infection.1 8

Fever (≥39.4°C) may occur; usually is evident 6–12 days after MMR and lasts 1–2 days.8 Febrile seizures have occurred rarely following administration of measles-containing vaccine.1 8 31 44

MMR: Use caution in individuals with a history of cerebral injury, individual or family history of seizures, or any other condition in which fever-induced stress should be avoided.1 8 Those receiving anticonvulsants should continue such therapy after vaccination.8 Monitor patient for temperature elevations following vaccination.1

MMRV (ProQuad): Use caution in individuals with a history of cerebral injury, individual or family history of seizures, or any other condition in which fever-induced stress should be avoided.66 (See Use of Fixed Combinations under Cautions.)

Interim results from an ongoing study indicate that the relative risk for febrile seizures 5–12 days after a dose of MMRV (ProQuad) in children 12–60 months of age (99% were 12–23 months of age) is 2.3 times higher than that reported with concurrent administration of a dose of Varivax and a dose of MMR given during a single health-care visit.65 (See Use of Fixed Combinations under Cautions.)

Thrombocytopenia reported after administration of MMR or monovalent vaccines containing measles, mumps, or rubella antigens (monovalent vaccines no longer commercially available in the US).1 8 37 38 39 40 44 Thrombocytopenia has worsened in those with preexisting thrombocytopenia and may worsen with subsequent doses.1 39

Consider potential benefits and risks when considering use of MMR in patients who developed thrombocytopenia or had worsening of thrombocytopenia with a previous dose.1 Serologic testing for antibody to measles, mumps, and rubella can be used to determine whether additional doses are necessary to provide protection.1

MMR contains recombinant human albumin.1

MMRV (ProQuad) contains albumin human.66 Since albumin human is prepared from pooled human plasma, it is a potential vehicle for transmission of human viruses, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD) or variant CJD (vCJD).66

Sensitivity Reactions

Anaphylaxis, anaphylactoid reaction, bronchial spasm, rash, urticaria, angioedema (including peripheral or facial edema), erythema multiforme, and Stevens-Johnson syndrome reported rarely.1 31 44

Prior to vaccine administration, question recipient and/or parent or guardian concerning reactions to previous doses of the vaccine or similar preparations.1 66

Individuals who have a hypersensitivity reaction to the first dose should be tested for immunity to measles, mumps, and rubella; if results indicate immunity, a second dose is not necessary.8 Any individual with an anaphylactic reaction to a previous dose should not receive another dose, regardless of results of serologic testing.8

Epinephrine and other appropriate agents should be readily available in case anaphylaxis or similar reaction occurs.1 66

MMR and MMRV (ProQuad) contain hydrolyzed gelatin as a stabilizer,1 66 which may rarely result in hypersensitivity reactions in some individuals.31 34 35 44 Do not use in individuals with a history of anaphylactic reactions to gelatin or gelatin-containing products.1 11 31 44 66

Immediate reactions (i.e., wheezing and dyspnea with or without urticaria) and other reactions (i.e., erythema and swelling at injection site) have occurred and may be related to gelatin hypersensitivity.31 34

Although skin testing for gelatin sensitivity before administering a gelatin-containing vaccine can be considered, there are no specific protocols for this purpose.8 11 Because gelatin used in vaccines manufactured in the US usually is derived from porcine sources and food gelatin may be derived solely from bovine sources, a negative food history does not exclude the possibility of a reaction to the gelatin contained in the vaccine.8 44

MMR and MMRV (ProQuad) contain trace amounts of neomycin and are contraindicated in those with a history of anaphylactic reactions to neomycin.1 66

Neomycin allergy usually results in delayed-type (cell-mediated) hypersensitivity reactions manifested as contact dermatitis.1 8 11 66 An erythematous pruritic nodule or papule may be evident 48–96 hours after vaccination.1

ACIP and AAP state that vaccines containing trace amounts of neomycin should not be used in individuals with a history of anaphylactic reaction to neomycin, but use of such vaccines may be considered in those with a history of delayed-type neomycin hypersensitivity if benefits of vaccination outweigh risks.8 11

Manufacturer of MMRV (ProQuad) states that if use of this vaccine is considered medically necessary in an individual with a history of anaphylactic reactions to neomycin, an allergist or immunologist should be consulted and the vaccine should be given only in settings where anaphylactic reactions can be managed appropriately.66

MMR and MMR component of MMRV (ProQuad) is produced in chick embryo cell culture.1 11 66

Individuals with a history of anaphylactic, anaphylactoid, or other immediate hypersensitivity reactions (e.g., hives, swelling of the mouth or throat, difficulty breathing, hypotension, shock) after egg ingestion may be at increased risk of immediate-type hypersensitivity reactions after receiving vaccines containing traces of chick embryo antigen.1 66

Consider potential benefits versus possible risks before administering MMR or MMRV (ProQuad) to an individual with a history of anaphylactic or other immediate hypersensitivity reaction to egg ingestion.1 66 Use extreme caution and have adequate treatment readily available in case a reaction occurs.1 66

Most individuals with a history of anaphylactic reactions to eggs are at low risk for anaphylactic reactions to MMR or MMRV (ProQuad);1 8 11 17 18 19 20 21 22 23 24 25 26 31 44 66 skin testing using the vaccines has not been predictive of which individuals will have reactions.1 8 66

Individuals who have egg allergies that are not anaphylactic in nature generally are not at increased risk of hypersensitivity reactions to vaccines produced in chick embryo cell cultures.1 8 11 66 There is no evidence that individuals with allergies to chickens or feathers are at increased risk of allergic reactions to such vaccines.1 8 66

General Precautions

MMR and MMRV (ProQuad) contain live, attenuated virus.1 66 There is a theoretical risk that transmission of vaccine virus could occur between vaccinees and susceptible contacts.1 66

Transmission of live, attenuated measles or mumps virus from vaccinees to susceptible contacts has not been reported.1

Although small amounts of the live, attenuated rubella virus are excreted from the nose or throat of most vaccinees 7–28 days after vaccination, there is no evidence that the vaccine virus is transmitted to susceptible contacts.1 14 52 However, rubella vaccine virus can be transmitted to infants via breast milk.1 (See Lactation under Cautions.)

Risk for transmission of live, attenuated varicella virus from individuals who receive MMRV (ProQuad) to susceptible close contacts is greatest if recipient develops a varicelliform rash following vaccination and/or the vaccine recipient is immunocompromised.27 Transmission of vaccine virus from vaccinees without a varicella-like rash has been reported, but not confirmed.66

Arthralgia and, rarely, transient arthritis may occur following vaccination with MMR or monovalent rubella vaccine (monovalent vaccine no longer commercially available in the US).3 14 44 52

Arthritis and arthralgia occur in up to 26% of susceptible adult women.3 14 44 Symptoms usually begin 1–4 weeks after vaccination and persist for 1 day to 3 weeks.14 Although these symptoms generally are well tolerated and rarely interfere with normal activities, they may persist for months or, rarely, for years.3 14 44 Joint symptoms are infrequent and generally of brief duration in children; the incidence in adolescent girls appears to be greater than that in children but less than that in adult women.3 14 44

When the fixed-combination vaccine containing measles, mumps, and rubella antigens (MMR) or the fixed-combination vaccine containing measles, mumps, rubella, and varicella antigens (MMRV; ProQuad) is used, consider contraindications and cautions related to each antigen.1 66

There is some evidence that the relative risk for febrile seizures in children 12–60 months of age after a dose of MMRV (ProQuad) is higher than that reported when a dose of MMR and a dose of monovalent varicella vaccine (Varivax) are given during a single health-care visit.65 (See Fever or Febrile Seizures under Cautions.)

When the first dose of MMR and first dose of varicella vaccine (Varivax) are indicated in infants and children 12 through 47 months of age, ACIP states that providers considering use of MMRV (ProQuad) should advise the parent or caregiver about the benefits and risks associated with MMRV (ProQuad) compared with the individual component vaccines.72 Although MMRV (ProQuad) results in 1 less injection, it is associated with a higher risk for fever and febrile seizures on days 5 through 12 after the first dose in children 12 through 23 months of age (i.e., 1 extra febrile seizure for every 2300–2600 doses of MMRV [ProQuad]).72 ACIP states that if providers face any barriers to clearly communicating these benefits and risks (e.g., language barrier), then MMR and monovalent varicella vaccine (Varivax) should be administered instead of MMRV (ProQuad).72

When the first dose of MMR and first dose of varicella vaccine (Varivax) are indicated in children ≥48 months of age and when second doses are indicated in those 15 months through 12 years of age, ACIP states that use of MMRV (ProQuad) generally is preferred over separate injections of the component vaccines;72 considerations should include provider assessment (e.g., number of injections, vaccine availability, likelihood of improved coverage, likelihood of patient return, storage and cost considerations), patient preference, and potential for adverse effects.72

The manufacturer recommends that MMRV (ProQuad) be used with caution in individuals with a history of cerebral injury, personal or family history of seizures, or any other condition in which fever-induced stress should be avoided.66 The ACIP states that a personal or family (i.e., sibling, parent) history of seizures is a precaution for use of MMRV (ProQuad).72 Studies suggest that children with a personal or family history of febrile seizures or family history of epilepsy are at increased risk for febrile seizures compared with children who do not have such histories.72 ACIP states that children with a personal or family history of seizures generally should receive a dose of MMR and a dose of varicella vaccine (Varivax) because the risks of using MMRV (ProQuad) in these children generally outweigh the benefits.72

Safety and efficacy of MMRV (ProQuad) in HIV-infected individuals not established;27 66 do not use this fixed-combination vaccine in HIV-infected individuals.27 76

MMR: May not protect all individuals from measles, mumps, and rubella.1 Safety and efficacy for postexposure prophylaxis following exposure to measles, mumps, or rubella not established.1

MMRV (ProQuad): May not protect all individuals from measles, mumps, rubella, and varicella.66 Safety and efficacy for postexposure prophylaxis after exposure to measles, mumps, rubella, or varicella not established.66

Immunity induced by measles, mumps, and rubella antigens is long-term in most individuals and may be lifelong.8 14 44 52 Although antibody levels may wane, revaccination usually results in an anamnestic immune response.58 60 61

Prevaccination serologic testing is not required before vaccination unless such testing is considered cost-effective.8 44 46 52 There is no evidence of increased risk of adverse effects if MMR is given to individuals already immune to measles, mumps, and rubella.8 52

When testing for mumps immunity, presence of mumps immunoglobulin G (IgG) by any commonly used serologic assay is acceptable evidence of mumps immunity.44 52 Those with equivocal serologic test results should be considered susceptible to mumps.44 52

The only reliable evidence of previous rubella infection is the presence of rubella IgG antibody.8 44 52 54 Although tests for IgM antibody have been used to diagnose acute and recent rubella infection, IgM tests should not be used to determine rubella immunity since false-positive results can occur.54 Occasionally an individual with a history of documented vaccination against rubella will have negative antibody results; such individuals may receive MMR and do not need to be retested for immunity.52 Those with equivocal serologic test results should be considered susceptible to rubella.44

Postvaccination serologic testing to confirm an immune response after vaccination with MMR is not recommended.44

A decision to administer or delay vaccination in an individual with a current or recent febrile illness depends on the severity of symptoms and etiology of the illness.1 11

ACIP states that minor acute illness, such as mild diarrhea or mild upper respiratory tract infection (with or without fever), generally does not preclude vaccination, but defer vaccination in individuals with moderate or severe acute illness (with or without fever).11

Although it has been theorized that there is a link between the antigens contained in MMR and neurodevelopmental disorders in children (autism),77 78 evidence has been insufficient to support an association between neurodevelopmental disorders and MMR.77 78 79 In 2004, the Immunization Safety Review Committee of the Institute of Medicine (IOM) examined the hypothesis that MMR is causally associated with autism and concluded that the evidence favors rejection of a causal relationship between MMR and autism.78

Theoretical risk that measles vaccination might exacerbate untreated tuberculosis.11

MMR and MMRV (ProQuad) are contraindicated in individuals with active untreated tuberculosis.1 66

Defer MMR or MMRV (ProQuad) in patients with active, untreated tuberculosis until antituberculosis therapy has been initiated.1 8 11 66 Tuberculin skin test reactivity in the absence of active tuberculosis is not a contraindication to live, attenuated virus vaccines.11 Tuberculin skin test is not a prerequisite for administration of MMR or MMRV (ProQuad).8 44 66 (See Specific Drugs and Laboratory Tests under Interactions.)

Improper storage or handling of vaccines may result in loss of vaccine potency and reduced immune response in vaccinees.1 53

Do not administer MMR or MMRV (ProQuad) that has been mishandled or has not been stored at the recommended temperature.1 53 66 (See Storage under Stability.)

Protect lyophilized and reconstituted vaccine from light at all times;1 53 66 exposure to light may inactivate the vaccine virus.1 53 66

Avoid freezing or exposing the diluent supplied by the manufacturer to freezing temperatures;1 53 66 diluent may be refrigerated or stored at room temperature.1 53 66 (See Storage under Stability.)

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.53

Discard reconstituted MMR vaccine if not used within 8 hours; do not freeze.1 53 Discard reconstituted MMRV (ProQuad) vaccine if not used within 30 minutes; do not freeze.66 (See Storage under Stability.)

Specific Populations

Category C.1 66

Contraindicated during pregnancy.1 11 44 50 66

Manufacturer states pregnancy should be avoided for 3 months after vaccination.1 66 ACIP, AAP and others state avoid pregnancy for 1 month following vaccination.8 11 52

Routine pregnancy testing before administering MMR not recommended.11 If a pregnant woman is vaccinated or became pregnant within 1–3 months after vaccination, advise her of the theoretical risks to the fetus.1 2 11 44 66 Inadvertent vaccination during pregnancy should not be regarded as a reason to consider termination of pregnancy.11 44

Not known whether measles or mumps vaccine virus is distributed into milk.1 Rubella vaccine virus is distributed into milk and may be transmitted to breast-fed infants; infants may have serologic evidence of rubella infection without severe disease.1 Manufacturer recommends caution in nursing women.1

ACIP and AAP state breast-feeding is not a contraindication to MMR since live vaccines appear to pose no special problems for the mother or her nursing infant.8 11 14 44

MMR: Safety and efficacy not established in children <6 months of age.1 8

MMRV (ProQuad): Safety and efficacy not established in children <12 months of age or children or adolescents ≥13 years of age.66

Routine immunization against measles, mumps, and rubella is initiated at 12 through 15 months of age.8 44 Infants 6 through 11 months of age may receive MMR if protection against measles is considered necessary (e.g., for measles outbreak control, for travelers).8 9 44 70 Infants <6 months of age usually have partial or complete protection against measles because of maternally derived antibodies.8 44

There is some evidence that infants born to mothers who had wild-type measles may not develop sustained antibody levels if vaccinated at <12 months of age and later revaccinated.1

MMR: Clinical studies did not include sufficient numbers of seronegative individuals ≥65 years of age to determine whether these individuals respond differently than younger individuals.1 Other reported clinical experience has not identified differences in responses between geriatric and younger individuals.1

MMRV (ProQuad): Not indicated in adults, including geriatric adults.66

Common Adverse Effects

MMR: Fever,1 31 44 52 transient rash,1 31 44 52 injection site reactions (pain, induration, edema).1 44

MMRV (ProQuad): Adverse effects similar to those reported when varicella vaccine and MMR are administered simultaneously at separate sites,66 but higher incidence of fever (≥38.9°),66 febrile seizures,65 and measles-like rash.66

• MMR is a fixed-combination preparation containing measles, mumps, and rubella virus vaccines live.1 Antigens contained in MMR are identical to those contained in monovalent measles, mumps, and rubella virus vaccines (monovalent vaccines no longer commercially available in the US).1

• MMR also is commercially available in the US as a fixed-combination vaccine containing measles, mumps, rubella, and varicella antigens (MMRV; ProQuad).66

• MMR stimulates active immunity to measles, mumps, and rubella by inducing production of specific IgG and IgM antibodies.1 11 52 MMRV (ProQuad) stimulates active immunity to measles, mumps, rubella, and varicella by inducing production of specific antibodies.66

• Vaccination with MMR produces an inapparent or mild, noncommunicable infection followed by antibody production.44 Vaccine-induced antibody titers generally are lower than those stimulated by natural measles, mumps, or rubella infection.14 44

• Individuals who fail to respond to the first dose of MMR generally respond to a second dose.44 52

• A single dose of MMR results in measles antibody in approximately 95% of children who receive the dose at 12 months of age and 98% of those who receive the dose at 15 months of age.8 44 52 Following a second dose given at least 4 weeks after the first, >99% of individuals have evidence of measles immunity.8 44 52

• A single dose of MMR is 75–95% effective in preventing mumps.10 44 Substantially higher levels of protection occur following a second dose.10

• A single dose of MMR given at ≥12 months of age results in production of rubella antibody and protection against clinical and symptomatic infection in >90–95% of vaccinees.8 14 44 52

• Clinical studies in healthy children 12–23 months of age indicate that those who received a single dose of MMRV (ProQuad) developed antibody levels against measles, mumps, rubella, and varicella that were similar to levels attained in children who received a single dose of MMR and a single dose of varicella vaccine (Varivax) concomitantly at separate sites.66

• Prior to administration of each vaccine dose, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s legal representative as required by the National Childhood Vaccine Injury Act (VISs are available at ).1 13 66

• Advise patient and/or patient’s parent or guardian of the risks and benefits of vaccination against measles, mumps, and rubella.1

• Importance of receiving the complete immunization series (2 doses in children and adolescents, 1 or 2 doses in adults) to ensure highest level of protection against measles, mumps, and rubella.1 5 8 52

• Advise patient that MMR may not provide protection in all vaccinees.1

• Advise postpubertal females receiving MMR that arthralgia and/or arthritis may occur 2–4 weeks after vaccination and that joint symptoms usually are self-limited.1

• Advise patient they should not receive MMR if they have a disease that weakens the immune system (e.g., cancer, HIV/AIDS) or are receiving treatment that may weaken the immune system (e.g., cancer treatment with radiation or drugs, corticosteroids).1

• Importance of contacting clinicians if a hypersensitivity reaction (difficulty breathing, hoarseness, wheezing, hives, paleness, weakness, fast heart beat, dizziness) or other moderate or severe reaction (high fever, behavior changes) occur following a dose.13 Clinicians or individuals can report any adverse reactions that occur following vaccination to Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or .1 13

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Advise women to avoid pregnancy for 1–3 months following a dose of MMR.1 13

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Applies to measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine: subcutaneous powder for injection

General

The most common adverse events were injection site reactions and fever.[Ref]

Other

Deaths have been reported following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals. Death as a direct consequence of disseminated measles vaccine virus infection has been reported in severely immunocompromised individuals in whom a measles-containing vaccine is contraindicated and who were inadvertently vaccinated.[Ref]

Very common (10% or more): Fever (up to 61.2%)
Common (1% to 10%): Viral infection
Uncommon (0.1% to 1%): Malaise, fatigue
Rare (0.01% to 0.1%): Otitis media
Very rare (less than 0.01%): Kawasaki syndrome
Postmarketing reports: Candidiasis, infection, ear pain, trauma, death[Ref]

Local

Very common (10% or more): Injection site pain/tenderness/soreness (up to 41.1%), injection site erythema (27%), injection site swelling (15.6%)
Common (1% to 10%): Injection site bruising, injection site rash, injection site pruritus
Postmarketing reports: Extravasation, injection-site complaints (burning and/or stinging of short duration, eczema, edema/swelling, hive-like rash, discoloration, hematoma, induration, lump, vesicles, wheal and flare), inflammation, venipuncture site hemorrhage, warm sensation, warm to touch[Ref]

Dermatologic

Very common (10% or more): Rash (up to 20.3%)
Common (1% to 10%): Measles-like rash, varicella-like rash, viral exanthema
Very rare (less than 0.01%): Erythema multiforme
Postmarketing reports: Atypical measles, cellulitis, herpes zoster, measles, skin infection, varicella (vaccine strain), Henoch-Schonlein purpura, herpes simplex, impetigo, panniculitis, pruritus, purpura, skin induration, Stevens-Johnson syndrome, sunburn, varicella-like rash, roughness/dryness[Ref]

Respiratory

Common (1% to 10%): Rhinorrhea, cough, upper respiratory infection
Uncommon (0.1% to 1%): Nasopharyngitis, rhinitis
Rare (less than 0.1%): Cough, bronchitis
Postmarketing reports: Influenza, respiratory infection, bronchial spasm, epistaxis, pneumonitis, pneumonia, pulmonary congestion, sinusitis, sneezing, sore throat, wheezing[Ref]

Nervous system

Encephalitis and encephalopathy have been reported approximately once for every 3 million doses of the combination of measles, mumps, and rubella vaccine. Some of these cases may have been caused by measles vaccines. The risk of serious neurological disorders for encephalitis and encephalopathy with wild-type measles is 1 per 2000 reported cases.

There have been reports of subacute sclerosing panencephalitis (SSPE) in children with no history of infection with wild-type measles but who 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 measles vaccine distribution in the United States (US), the association of SSPE cases to measles vaccination is about one case per million vaccine doses distributed. The association with wild-type measles virus infection is 6 to 22 cases of SSPE per million cases of measles.

Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination. Although a causal relationship between other strains of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn (TM) mumps vaccine to aseptic meningitis.[Ref]

Uncommon (0.1% to 1%): Somnolence, lethargy
Rare (0.01% to 0.1%): Febrile seizures
Very rare (less than 0.01%): Meningitis, encephalitis, cerebrovascular accident, cerebellitis, cerebellitis like symptoms, Guillain Barré syndrome, transverse myelitis, peripheral neuritis
Postmarketing reports: Acute disseminated encephalomyelitis (ADEM), afebrile convulsions or seizures, aseptic meningitis, ataxia, Bell's palsy, convulsion, dizziness, dream abnormality, encephalitis, encephalopathy, febrile seizure, headache, hypersomnia, measles inclusion body encephalitis, ocular palsies, paresthesia, polyneuritis, polyneuropathy, subacute sclerosing panencephalitis, syncope, transverse myelitis, tremor, nerve deafness[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, vomiting
Uncommon (0.1% to 1%): Parotid swelling
Very rare (less than 0.01%): Mumps-like syndrome
Postmarketing reports: Parotitis, abdominal pain, flatulence, hematochezia, mouth ulcer, lip abnormality[Ref]

Psychiatric

Common (1% to 10%): Irritability
Uncommon (0.1% to 1%): Abnormal crying, nervousness, insomnia, somnolence
Postmarketing reports: Agitation, apathy, nervousness[Ref]

Hematologic

Cases of thrombocytopenia have been reported after use of measles; measles, mumps, and rubella (MMR); and varicella vaccination. Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination. In addition, individuals who experienced thrombocytopenia following the first dose of MMR may develop thrombocytopenia with repeat doses.[Ref]

Uncommon (0.1% to 1%): Lymphadenopathy
Very rare (less than 0.01%): Thrombocytopenia, thrombocytopenic purpura
Postmarketing reports: Aplastic anemia, lymphadenitis, regional lymphadenopathy, thrombocytopenia[Ref]

Hypersensitivity

Very rare (less than 0.01%): Allergic reactions (including anaphylactic and anaphylactoid reactions)
Postmarketing reports: Anaphylaxis and related phenomena such as angioneurotic edema, facial edema, and peripheral edema, anaphylaxis in individuals with or without an allergic history[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia[Ref]

Musculoskeletal

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. Recipients of rubella vaccine may develop chronic joint symptoms. Arthralgia and/or arthritis, and polyneuritis after wild-type rubella virus infection vary in frequency and severity with age and gender, being greatest in adult females and least in pre-pubertal children. Following vaccination in children, reactions in joints are uncommon (0 to 3%) and of brief duration. In women, incidence rates for arthritis and arthralgia are higher than those seen in children (12 to 26%), and the reactions tend to be more marked and of longer duration (e.g., months or years). In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and adult women.[Ref]

Very rare (less than 0.01%): Arthralgia, arthritis
Postmarketing reports: Musculoskeletal pain, myalgia, pain of the hip, leg, or neck, swelling, stiffness[Ref]

Genitourinary

Very rare (less than 0.01%): Orchitis, epididymitis[Ref]

Ocular

Postmarketing reports: Edema of the eyelid, irritation, necrotizing retinitis (reported only in immunocompromised individuals), optic neuritis, retinitis, retrobulbar neuritis[Ref]

Some side effects of measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

1 dose (0.5 mL) subcutaneously in the outer deltoid or higher anterolateral thigh

Comments:
-The first dose is usually administered at 12 to 15 months of age.
-A second dose, if needed, is usually administered at 4 to 6 years of age.

Use: Active immunization for the prevention of measles, mumps, rubella, and varicella in children 12 months through 12 years of age.

Some live virus vaccines have caused birth defects in animals. It is unknown whether this vaccine can cause fetal harm or affect reproduction capacity. Currently available live virus vaccines have not caused teratogenic effects in humans. Use caution as live virus vaccines have been shown to cross the placenta and infect the fetus. Contracting wild-type measles during pregnancy increased rates of spontaneous abortion, stillbirth, congenital defects, and prematurity. There are no adequate studies of the vaccine strain of measles virus in pregnancy. However, it is prudent to assume that the vaccine strain is capable of inducing adverse fetal effects. Mumps infection during the first trimester may increase the rate of spontaneous abortion. Although mumps vaccine virus can infect the placenta and fetus, there is no evidence that it causes congenital malformations in humans. In a 10 year survey of over 700 women who received rubella vaccine within 3 months before or after conception (of whom 189 received the Wistar RA 27/3 strain), none of the newborns had rubella-like birth defects. Wild-type varicella can cause congenital varicella infection. A pregnancy registry maintained from 1995 to 2013 tracked over 800 women who received varicella containing vaccines within 3 months prior to or during pregnancy; none of the infants had abnormalities consistent with varicella syndrome. All exposures to varicella containing vaccines during pregnancy or within three months prior to conception should be reported as suspected adverse reactions at www.vaers.hhs.gov. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

Use is contraindicated. AU TGA pregnancy category: B2 US FDA pregnancy category: Contraindication Comments: -Avoid pregnancy for 3 months after vaccination. -Test women of childbearing age for rubella antibodies prior to pregnancy; offer rubella vaccine to all non-pregnant seronegative women.