Applies to measles virus vaccine / mumps virus vaccine / rubella virus vaccine: powder for solution, powder for suspension.

Serious side effects

Along with its needed effects, measles virus vaccine/mumps virus vaccine/rubella virus vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking measles virus vaccine/mumps virus vaccine/rubella virus vaccine:

More common

• Difficulty in breathing or swallowing
• fever over 39 °C (102 °F)
• itching, especially of the feet or hands
• reddening of the skin, especially around the ears
• swelling of the eyes, face, or inside of the nose
• unusual tiredness or weakness

Less common

• Difficulty in moving
• joint pain
• muscle pain or stiffness

Incidence not known

• Back pain, sudden and severe
• black, tarry stools
• bleeding gums
• blindness or vision changes
• blood in the urine or stools
• bloody nose
• burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
• burning of the face or mouth
• change in walking and balance
• chest tightness
• clumsiness or unsteadiness
• confusion
• cough
• dizziness
• drowsiness
• fainting
• fast heartbeat
• fever
• general feeling of illness
• heavier menstrual periods
• inability to move the arms and legs
• irritability
• large, flat, blue, or purplish patches in the skin
• muscle weakness, sudden and progressing
• nausea
• pain in the stomach, groin, or scrotum
• pain or burning with urination
• painful knees and ankles
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• raised red swellings on the skin, the buttocks, legs, or ankles
• seizures
• severe headache
• skin rash
• stiff neck or back
• stomach pain
• sudden numbness and weakness in the arms and legs
• swelling of the scrotum
• swollen, painful, or tender lymph glands on the side of the face or neck
• unusual bleeding or bruising
• vomiting
• weakness in the hands or feet

Other side effects

Some side effects of measles virus vaccine/mumps virus vaccine/rubella virus vaccine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• loss of appetite
• sleepiness

Less common

• Runny nose
• sore throat
• vague feeling of bodily discomfort

For Healthcare Professionals

Applies to measles virus vaccine / mumps virus vaccine / rubella virus vaccine: injectable powder for injection, subcutaneous powder for injection.

General

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

Local

Very common (10% or more): Redness at the injection site, injection site pain, injection site swelling

Common (1% to 10%): Injection site bruising, burning and/or stinging at injection site

Uncommon (0.1% to 1%): Injection site rash

Postmarketing reports: Vesicles at injection site, wheal and flare at injection site^[Ref]

Other

Very common (10% or more): Fever equal to or greater than 38C (rectal) or 37.5C (axillary/oral)

Common (1% to 10%): Fever over 39.5C (rectal) or 39C (axillary/oral)

Uncommon (0.1% to 1%): Otitis media, injury

Rare (less than 0.1%): Death from various and in some cases unknown causes

Postmarketing reports: Malaise, peripheral edema, papillitis, swelling, tenderness^[Ref]

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Dizziness

Rare (less than 0.1%): Febrile convulsions

Postmarketing reports: Encephalitis, cerebellitis, cerebellitis like symptoms (including transient gait disturbance and transient ataxia), Guillain-Barre syndrome, transverse myelitis, peripheral neuritis, subacute sclerosing panencephalitis, afebrile convulsions or seizures, encephalopathy, measles inclusion body encephalitis, paresthesia, polyneuritis, polyneuropathy, optic neuritis, retrobulbar neuritis, syncope^[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, pharyngitis, bronchitis, cough, respiratory disorder, rhinitis

Uncommon (0.1% to 1%): Nasopharyngitis, rhinorrhea, laryngitis, stridor, epistaxis, sinusitis

Rare (less than 0.1%): Pneumonia, pneumonitis

Postmarketing reports: Bronchial spasm, sore throat^[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Urticaria, dermatitis, eczema, pruritus, herpes simplex, herpes zoster, skin exfoliation, nail disorder

Frequency not reported: Panniculitis

Postmarketing reports: Erythema multiforme, panniculitis, purpura, skin induration, Stevens-Johnson syndrome, pruritus^[Ref]

Psychiatric

Common (1% to 10%): Nervousness

Uncommon (0.1% to 1%): Abnormal crying, insomnia

Postmarketing reports: Irritability^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea

Uncommon (0.1% to 1%): Parotid gland enlargement, vomiting, gastrointestinal disorder, toothache, enteritis, gastroenteritis, stomatitis, stomatitis aphthous, abdominal pain

Rare (less than 0.1%): Nausea

Frequency not reported: Pancreatitis^[Ref]

Hematologic

Uncommon (0.1% to 1%): Lymphadenopathy, anemia

Rare (less than 0.1%): Thrombocytopenia, thrombocytopenic purpura

Frequency not reported: Leukocytosis^[Ref]

Immunologic

Uncommon (0.1% to 1%): Viral infection

Frequency not reported: Atypical measles

Postmarketing reports: Meningitis, measles-like syndrome, mumps-like syndrome (including orchitis, epididymitis, and parotitis)^[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis

Postmarketing reports: Ocular palsies, retinitis^[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia

Frequency not reported: Diabetes mellitus^[Ref]

Hypersensitivity

Rare (less than 0.1%): Allergic reactions

Postmarketing reports: Anaphylactic reactions (including related phenomenon such as angioneurotic edema, facial edema, and peripheral edema), anaphylactoid reaction^[Ref]

Cardiovascular

Rare (less than 0.1%): Vasculitis^[Ref]

Genitourinary

Rare (less than 0.1%): Epididymitis, orchitis^[Ref]

Musculoskeletal

Postmarketing reports: Arthralgia, arthritis, myalgia^[Ref]

The vaccine has rarely been associated with chronic joint symptoms. The incidence of arthritis and arthralgia is generally higher in adult women than in children (women, 12% to 26%; children, 0% to 3%), and symptoms tend to be more marked and of longer duration, persisting for months or years (rare). In adolescent girls, the incidence of reactions appears to be intermediate between those seen in children and in women. These reactions are generally well tolerated and rarely interfere with normal activities, even in women over 35 years old.^[Ref]