Note: This document contains side effect information about measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine. Some dosage forms listed on this page may not apply to the brand name ProQuad.

Applies to measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine: parenteral for injection for sub-q use.

Side effects include:

MMR: Fever, transient rash, injection site reactions (pain, induration, edema).

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

For Healthcare Professionals

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

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]

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]

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

Uncommon (0.1% to 1%): Lymphadenopathy

Very rare (less than 0.01%): Thrombocytopenia, thrombocytopenic purpura

Postmarketing reports: Aplastic anemia, lymphadenitis, regional lymphadenopathy, thrombocytopenia^[Ref]

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]

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

Very rare (less than 0.01%): Arthralgia, arthritis

Postmarketing reports: Musculoskeletal pain, myalgia, pain of the hip, leg, or neck, swelling, stiffness^[Ref]

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]

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]