ProQuad Side Effects
Generic name: measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine
Medically reviewed by Drugs.com. Last updated on May 31, 2024.
Note: This document provides detailed information about ProQuad Side Effects associated with measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine. Some dosage forms listed on this page may not apply specifically to the brand name ProQuad.
Applies to measles virus vaccine / mumps virus vaccine / rubella virus vaccine / varicella virus vaccine: injectable powder for injection.
Important warnings
This medicine can cause some serious health issues
Your child should not receive a booster vaccine if he or she had a life threatening allergic reaction after the first shot.
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Call the doctor at once if your child has any of these serious side effects:
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a high fever;
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walking problems;
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seizures;
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severe skin problems or skin infection;
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fever, chills, cough with mucus, chest pain, feeling short of breath;
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stiff neck, light sensitivity;
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confusion; or
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easy bruising, purple or red spots under your skin.
Common side effects may include:
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pain, tenderness, soreness, redness, or swelling where the shot was given;
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fever;
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rash that looks like chickenpox; or
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irritability.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For healthcare professionals
Applies to measles virus vaccine/mumps virus vaccine/rubella virus vaccine/varicella virus vaccine: injectable powder for injection, subcutaneous powder for injection.
General adverse events
The most common adverse events were injection site reactions, swelling, irritability, and fever.[Ref]
Cardiovascular
- Rare (0.01% to 0.1%): Flushing, vasculitis (includes Henoch Schonlein purpura and Kawasaki syndrome)
- Postmarketing reports: Blood extravasation[Ref]
Dermatologic
- Very common (10% or more): Rash (up to 20.3%), erythema (up to 14.3%)
- Common (1% to 10%): Measles-like rash, varicella-like rash, viral exanthema
- Uncommon (0.1% to 1%): Viral rash, dermatitis (including contact and atopic), erythema, rubella-like rash, urticaria
- Rare (0.01% to 0.1%): Drug eruption, erythema multiforme
- Postmarketing reports: Cellulitis, atypical measles, 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, acute hemorrhagic edema[Ref]
Gastrointestinal
- Common (1% to 10%): Diarrhea, vomiting
- Uncommon (0.1% to 1%): Parotid swelling, gastroenteritis
- Rare (0.01% to 0.1%): Viral gastroenteritis, nausea
- Very rare (less than 0.01%): Mumps-like syndrome (including orchitis, epididymitis and parotitis)
- Postmarketing reports: Parotitis, abdominal pain, flatulence, hematochezia, mouth ulcer, lip abnormality[Ref]
Genitourinary
- Very rare (less than 0.01%): Orchitis, epididymitis[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, MMR (measles, mumps, and rubella) 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
- Rare (0.01% to 0.1%): Allergy, hypersensitivity
- Very rare (less than 0.01%): Allergic reactions (including anaphylactic and anaphylactoid reactions)
- Postmarketing reports: Anaphylaxis, angioneurotic edema, facial edema, peripheral edema, anaphylactoid reaction[Ref]
Local
- Very common (10% or more): Injection site pain, tenderness, soreness (up to 41.1%), injection site erythema (up to 27%), injection site swelling (up to 15.6%)
- Common (1% to 10%): Injection site bruising, injection site rash, injection site pruritus, injection site ecchymosis
- Uncommon (0.1% to 1%): Injection site induration, warmth, hemorrhage, mass, lump, malaise
- Rare (0.01% to 0.1%): Injection site discoloration, injection site reaction
- Postmarketing reports: Injection-site complaints (burning and/or stinging of short duration, eczema, edema, hive-like rash, discoloration, hematoma, induration, lump, vesicles, wheal, and flare), inflammation, venipuncture site hemorrhage, warm sensation, warm to touch[Ref]
Metabolic
- Uncommon (0.1% to 1%): Anorexia, decreased appetite[Ref]
Musculoskeletal
- Very common (10% or more): Swelling (up to 12%)
- Rare (0.01% to 0.1%): Arthralgia, arthritis
- Postmarketing reports: Musculoskeletal pain, myalgia, pain of the hip, leg stiffness, neck 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]
Nervous system
- Uncommon (0.1% to 1%): Somnolence, lethargy, febrile seizures
- Rare (0.01% to 0.1%): Ataxia, headache, febrile convulsions, encephalitis, cerebrovascular accident, cerebellitis, cerebellitis like symptoms (including transient gait disturbance and transient ataxia)
- Very rare (less than 0.01%): Guillain Barré syndrome, meningitis, 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, Guillain-Barre syndrome, cerebrovascular accident[Ref]
Encephalitis and encephalopathy have been reported 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 one 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 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]
Ocular
- Rare (0.01% to 0.1%): Conjunctivitis, tearing, visual discomfort
- Postmarketing reports: Edema of the eyelid, irritation, necrotizing retinitis (reported only in immunocompromised individuals), optic neuritis, retinitis, retrobulbar neuritis, papillitis, ocular palsies[Ref]
Other
- Very common (10% or more): Fever (up to 61.2%), redness (up to 31%)
- Common (1% to 10%): Viral infection
- Uncommon (0.1% to 1%): Asthenia, fatigue, ear infection/otitis, otitis media, pharyngitis
- Rare (0.01% to 0.1%): Flu like illness, influenza like illness, contusion
- Very rare (less than 0.01%): Kawasaki syndrome
- Postmarketing reports: Candidiasis, infection, ear pain, trauma, death[Ref]
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. Disseminated mumps and rubella vaccine virus infection have also been reported.[Ref]
Psychiatric
- Common (1% to 10%): Irritability
- Uncommon (0.1% to 1%): Abnormal crying, nervousness, insomnia, sleep disorder
- Rare (0.01% to 0.1%): Clinging
- Postmarketing reports: Agitation, apathy, nervousness[Ref]
Respiratory
- Common (1% to 10%): Rhinorrhea, cough, upper respiratory infection
- Uncommon (0.1% to 1%): Nasopharyngitis, rhinitis, nasal congestion, respiratory congestion, rhinorrhea
- Rare (less than 0.1%): Cough, bronchitis, tonsillitis
- Postmarketing reports: Influenza, respiratory infection, bronchial spasm, epistaxis, pneumonitis, pneumonia, pulmonary congestion, sinusitis, sneezing, sore throat, wheezing[Ref]
References
1. (2005) "Product Information. ProQuad (measles/mumps/rubella/varicella virus vaccine)." Merck & Co., Inc
2. Cerner Multum, Inc. "Australian Product Information."
3. (2022) "Product Information. ProQuad (measles/mumps/rubella/varicella virus vaccine)." Merck Sharp & Dohme (Australia) Pty Ltd
4. (2022) "Product Information. Priorix-Tetra (measles/mumps/rubella/varicella virus vaccine)." GlaxoSmithKline Australia Pty Ltd
5. (2023) "Product Information. ProQuad (measles/mumps/rubella/varicella virus vaccine)." Merck Sharp & Dohme LLC
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Further information
ProQuad side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.